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    Company profile for Kaken Pharmaceuticals

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    About

    The origin of KAKEN PHARMACEUTICAL Co., Ltd., can be traced back to the Institute of Physical and Chemical Research ( Riken ), established in 1917. The Company started pharmaceutical business with full-scale development of penicillin and streptomycin based on Riken's own technologies in 1948. 　The new headquarters were opened in 1998 in Bunkyo Green Court, an urban community center in Tokyo, Japan, where KAKEN's origin, Rik...
    The origin of KAKEN PHARMACEUTICAL Co., Ltd., can be traced back to the Institute of Physical and Chemical Research ( Riken ), established in 1917. The Company started pharmaceutical business with full-scale development of penicillin and streptomycin based on Riken's own technologies in 1948. 　The new headquarters were opened in 1998 in Bunkyo Green Court, an urban community center in Tokyo, Japan, where KAKEN's origin, Riken, started. 　KAKEN's ongoing quest is to bring smiles and happiness to as many people as possible. For this purpose, the Company strives to improve the quality of life of patients through the development and distribution of superior drugs.

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    Kaken Pharmaceuticalsjapan Flag
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    20th Floor, Bunkyo Green Court
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    +81-3-5977-5002
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    "50 Years of Innovation: Mikart

    mic"50 Years of Innovation: Mikart's legacy and what's next in CDMO excellence"

    This week, SpeakPharma interviews Michael Kallelis, CEO of Mikart, a leading contract development and manufacturing organization (CDMO) celebrating its 50th anniversary in the pharmaceutical industry. Based in the United States, Mikart has built a reputation for technical expertise, flexible business terms, and specialized capabilities in pharmaceutical development services. In this exclusive interview, Kallelis discusses how Mikart maintains its competitive edge through its Pharmaceutical Development Services team, quality control framework, and commitment to customized business solutions. Kallelis also explores the company's focus on liquid suspensions manufacturing, driven by growing demand from aging populations and pediatric patients, and explains how Mikart balances traditional family business values with modern innovation. HIGHLIGHTS// celebrating its 50th anniversary/ reputation for technical expertise/ how Mikart maintains its competitive edge Mikart is celebrating 50 years in business this year — what are some of the major milestones that have shaped the company's journey?  Over our 50-year history, we've celebrated many memorable milestones, but one of the most significant in recent years has been achieving our growth objectives. This success was driven by the strategic expansion of our Pharmaceutical Development Services team, the completion of full aggregate serialization in our packaging department, modernization of our IT systems, enhanced productivity, and our ability to attract both new and returning customers. HIGHLIGHTS// expansion of our Pharmaceutical Development Services team/ completion of full aggregate serialization/ attract both new and returning customers How has Mikart maintained its competitive edge in a constantly evolving pharmaceutical landscape? Our customers consistently tell us that what sets us apart is our technical expertise, high service level, and flexible, customized business terms. At the core of our competitiveness is our focus on Pharmaceutical Development Services (PDS). Mikart's PDS opinion leaders are actively engaged in business development and form early, collaborative relationships with our customers' technical teams. From the outset, our prospects and clients work directly with Mikart's experienced formulation chemists, analytical method developers, and process-oriented engineers to design robust, reproducible, and efficient processes. This hands-on development approach is supported by a comprehensive quality control testing framework — covering raw material testing, in-process checks, on-site microbiological testing, and in-house stability studies. Oversight is provided by our robust Quality Management System, managed by a dedicated Quality Assurance and Regulatory Affairs team. The result is disciplined problem-solving, timely FDA submissions, and a "right-first-time" philosophy that accelerates time-to-market. We operate with a strong sense of urgency and consistently deliver a high level of customer satisfaction. What truly differentiates Mikart is our commitment to customized business terms that eliminate common roadblocks seen with other CDMOs. Our secret sauce is our exceptional service and flexibility in helping our customers bring innovative medicines to patients. HIGHLIGHTS// technical expertise, high service level/ flexible, customized business terms/ comprehensive quality control testing framework/ dedicated Quality Assurance and Regulatory Affairs team/ timely FDA submissions/ accelerates time-to-market What capabilities or services does Mikart offer today that didn't exist 10 or 20 years ago? Mikart was an early leader in serialization, implementing full capabilities well ahead of the industry timeline. This proactive approach has kept our packaging team in high demand. We also upgraded our tablet compression equipment to enhance both speed and reliability. To support growing development needs, we invested in new lab-scale development equipment, unit dose cup filling, sachet packaging, low-humidity suites, and a brand-new suite dedicated to closed-system manufacturing of liquids and suspensions. Most recently, we launched a multi-million dollar expansion of our packaging lines to support higher-speed tablet filling, powder-in-bottle formats, and new liquid fill capabilities. HIGHLIGHTS// early leader in serialization/ upgraded our tablet compression equipment/ multi-million dollar expansion of our packaging lines Why are liquid suspensions becoming such a key focus, and how is Mikart positioned? Formulating suspensions is a complex process that requires specialized expertise and equipment. According to our customers, few mid-market CDMOs do it well — and Mikart is one of them. There is growing industry demand for high-quality suspension manufacturing, driven by the needs of the aging baby boomer population and pediatric patients. For both groups, swallowing tablets or capsules can be difficult, making oral liquid suspensions a more practical alternative. In addition to being easier to administer, suspensions offer pharmacological advantages and can improve dosing compliance. Enhanced flavoring techniques further improve the patient experience — especially for children and infants — by making medicines more palatable. HIGHLIGHTS// growing industry demand for high-quality suspension manufacturing/ suspensions offer pharmacological advantages/ improve dosing compliance How does Mikart balance tradition with innovation to meet modern customer demands?  At Mikart, we work hard to preserve the values of a traditional family business, even as we continue to modernize. Our goal is to make every customer feel like they are our top priority. Each customer is supported by a dedicated project manager who serves as their primary point of contact, along with direct access to key team members across departments. This structure ensures our customers are never isolated from our subject matter experts and can get timely, accurate answers to their questions. We're also mindful of the "technology trap" — the tendency to pursue every new innovation at the expense of focus and efficiency. Instead, we rely on market data and customer trends to guide our investments, enabling us to concentrate our resources and capital on technologies that meet real market needs. HIGHLIGHTS// customer is supported by a dedicated project manager/ customers are never isolated from our subject matter experts/ we rely on market data and customer trends to guide our investments/ meet real market needs Looking ahead, what's in store for Mikart in the next 5-10 years? Mikart's strategic plan is now in full motion, and with the momentum we've built, 50 percent growth is within reach. This projection is backed by a strong pipeline of annual FDA filings, a growing customer base, and a robust portfolio of active Pharmaceutical Development Services projects. As we grow, we remain committed to delivering exceptional service and continuously evolving to meet the changing needs of our customers. With renewed political emphasis on domestic manufacturing for the US market, we are ideally positioned to support the rapid, cost-effective development and production of high-quality medicines here at home. As we approach our 50th anniversary in the CDMO industry, we celebrate our legacy and look forward with optimism to the opportunities ahead in the next 5 to 10 years. HIGHLIGHTS// 50 percent growth is within reach/ strong pipeline of annual FDA filings 

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    https://www.pharmacompass.com/speak-pharma/50-years-of-innovation-mikart-s-legacy-and-what-s-next-in-cdmo-excellence

    PharmaCompass
    17 Jul 2025
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    VLOG #PharmaReel

    [Sponsored by another company]

    ReelPharmaVersatile Source for Prostaglandin APIsVersatile Source for Prostaglandin APIs

    Versatile Source for Prostaglandin APIs
    Versatile Source for Prostaglandin APIs

    reelVersatile Source for Prostaglandin APIs

    This PharmaReel spotlights Cayman Pharma’s expertise in Prostaglandin APIs, backed by Czech NCA (SUKL, USKVBL) and USFDA approvals. With patented technology, process excellence, and quality focus, Cayman is a trusted partner for reliable CDMO services.

    Impressions: 7941

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    FDA approvals drop 24% in H1 2025; GSK’s UTI med, Vertex’s non-opioid painkiller lead pack of first-in-class meds

    FDA approvals drop 24% in H1 2025; GSK’s UTI med, Vertex’s non-opioid painkiller lead pack of first-in-class meds

    It has been a turbulent year for the US Food and Drug Administration (FDA), marked by reductions in both staff and budget, shake-ups at the top and a reduction in inspections. This upheaval has clearly impacted the functioning of the agency, with reports of missed deadlines and reduced responsiveness. This disruption resulted in a slowdown in new drug approvals in the first half of 2025 (H1 2025), as opposed to the same period last year. Incidentally, drug approvals in H1 2024 were also down by 19 percent compared to H1 2023. FDA’s Center for Drug Evaluation and Research (CDER) approved 16 novel drugs in H1 2025, down from 21 in H1 2024, a decline of nearly 24 percent. Of these, nine were small molecules and seven were biologics. The period saw eight first-in-class therapies get CDER’s approval, as opposed to 17 in H1 2024. FDA’s Center for Biologics Evaluation and Research (CBER) approved seven biologics in H1 2025, compared to eight in the same period last year. In comparison, both Health Canada and the European Medicines Agency (EMA) reported a strong rebound in approvals and authorizations, respectively. Health Canada approved 20 drugs in H1 2025, as opposed to 10 in H1 2024. Similarly, EMA authorized 19 new therapies in H1 2025, compared to 15 in H1 2024. Notably, EMA’s pending decisions increased to 25 in H1 2025, from 14 in the same period last year, while conditional authorizations remained static at five. This underscores EMA’s active regulatory pipeline, suggesting that more drugs could be approved in Europe soon.   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available) Vertex’s non-opioid painkiller, GSK’s antibiotic for UTI, Merck’s RSV antibody bag FDA nods Oncology remained the single largest category in H1 2025 with seven new drugs being approved by the FDA, followed by four rare diseases and disorders and as many infections and infective diseases.  The eight drugs that were designated first-in-class in H1 2025 are: Journavx (Suzetrigine), Imaavy (nipocalimab), Emrelis (telisotuzumab vedotin), Blujepa (gepotidacin mesylate), Qfitlia (fitusiran), Avmapki Fakzynja Co-Pack (avutometinib potassium/defactinib hydrochloride), Tryptyr (acoltremon), and Andembry (garadacimab). In January, a new class of non-opioid pain therapy made a debut — FDA approved Vertex Pharmaceuticals’ Journavx (suzetrigine). This first-in-class oral analgesic could bring in US$ 2.9 billion in sales for Vertex by 2030. The half year also saw a new oral antibiotic — GSK’s Blujepa (gepotidacin) — for treating uncomplicated urinary tract infections (uUTIs) bag FDA approval. This is the first new antibiotic for uUTIs in nearly three decades. It treats infections caused by resistant pathogens such as E. coli and K. pneumoniae. In June, Merck’s Enflonsia (clesrovimab), a long-acting monoclonal antibody, won FDA approval to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants entering their first RSV season. A single 105 mg dose provides protection for about five months, the length of a typical RSV season. Enflonsia could bring in US$844 million in annual sales by 2030.   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)  FDA approves four meds for rare diseases, including SpringWorks’ Gomekli, Novartis’ Vanrafia In H1 2024, rare genetic diseases had witnessed some significant approvals. The trend continued in H1 2025. In February, Gomekli (mirdametinib), developed by SpringWorks Therapeutics, became the first approved therapy for neurofibromatosis type 1 (a genetic disorder that causes tumors to grow on nerve tissues) in adult and pediatric patients who have symptomatic plexiform neurofibromas (benign, complex nerve tumors) not amenable to complete resection. Analysts expect peak sales of around US$ 0.8 billion by 2030. Post this approval, SpringWorks got acquired by Merck KGaA for approximately US$ 3.9 billion. The same month, Ono Pharma-owned Deciphera’s Romvimza (vimseltinib) became the first oral therapy approved for another rare disease known as symptomatic tenosynovial giant cell tumor. This is a benign but aggressive growth that can be painful. This new drug offers patients an option beyond surgery. In March, Sanofi’s Qfitlia (fitusiran) was approved for routine prophylaxis in hemophilia A or B, with or without inhibitors. And in April, Novartis’ Vanrafia (atrasentan) was granted accelerated approval for IgA nephropathy (a chronic autoimmune kidney disease), which is at the risk of rapid progression. Vanrafia could bring in sales of over US$ 735 million by 2030. Johnson & Johnson secured approval for Imaavy (nipocalimab-aahu) for generalized myasthenia gravis (a chronic autoimmune disease that causes muscle weakness) in adults and adolescents. Imaavy’s sales could cross US$1.17 billion by 2030. Rare diseases continue to attract regulatory attention, with the trend carrying into the current quarter. July witnessed two noteworthy rare-disease approvals — Ekterly (garadacimab), CSL’s once-monthly prophylactic treatment for hereditary angioedema (a genetic disorder that causes recurrent episodes of swellings), and Sephience (pegvaliase-abcx), BioMarin’s new therapy for phenylketonuria (a rare metabolic disorder).   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)  FDA greenlights new oncology therapies, including Astra’s Datroway, AbbVie’s Emrelis The field of oncology saw some notable new drug approvals. In January, Datroway (datopotamab deruxtecan), an antibody-drug conjugate (ADC) developed by AstraZeneca and Daiichi Sankyo, was granted approval for adults with unresectable or metastatic, hormone receptor-positive, HER2-negative breast cancer. Later, in June, the FDA granted accelerated approval  to AstraZeneca;s Datroway for adults with locally advanced or metastatic, EGFR-mutated non-small cell lung cancer. The drug’s peak annual sales are projected at about US$ 4.2 billion by 2030. In May, Emrelis (telisotuzumab vedotin-tllv), AbbVie’s ADC was granted FDA’s accelerated approval. Emrelis treats locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) characterized by significantly increased levels of the c-Met protein in cancer cells. FDA also approved a companion diagnostic test — Roche's Ventana — in May to determine the c-Met protein biomarker status in order to identify patients eligible for Emrelis.  The same month, FDA also granted accelerated approval to Verastem’s Avmapki Fakzynja Co-pack, a dual oral therapy for adults with KRAS‑mutated recurrent low‑grade serous ovarian cancer (LGSOC). This novel regimen combines two inhibitors — avutometinib and defactinib — to disrupt critical signaling pathways that fuel tumor growth. In ophthalmology, Alcon re-entered the prescription pharmaceutical market with Tryptry (acoltremon), a first-in-class TRPM8 agonist for dry eye disease, which stimulates corneal nerves to increase tear production.   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)  Our view The changes in the FDA are clearly having a far-reaching impact on the global pharmaceutical industry. There have been reports of drugmakers losing confidence in the FDA, which has been a gold standard for drug regulation. Some American biotechs are shifting early trials outside of the US. With EMA and Health Canada authorizing/approving a larger number of drugs in H1 2025, we do see some changes underway that may eventually reshape drug development.  
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    Impressions: 2115

    https://www.pharmacompass.com/radio-compass-blog/fda-approvals-drop-24-in-h1-2025-gsk-s-uti-med-vertex-s-non-opioid-painkiller-lead-pack-of-first-in-class-meds

    #PharmaFlow by PHARMACOMPASS
    28 Aug 2025
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    NEWS #PharmaBuzz

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    Kaken Strengthens Late-Stage HAE Portfolio with $32 M Astria Deal
    Kaken Strengthens Late-Stage HAE Portfolio with $32 M Astria Deal

    09 Aug 2025

    // FIERCE BIOTECH

    https://www.fiercebiotech.com/biotech/kaken-strengthens-late-stage-hae-portfolio-32m-japanese-deal-astrias-navenibart

    FIERCE BIOTECH
    09 Aug 2025
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    KalVista sells Japanese rights for HAE drug to Kaken
    KalVista sells Japanese rights for HAE drug to Kaken

    08 Apr 2025

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20250408053048/en/KalVista-Pharmaceuticals-Enters-Into-Licensing-Agreement-With-Kaken-Pharmaceutical-to-Commercialize-Sebetralstat-for-HAE-in-Japan

    BUSINESSWIRE
    08 Apr 2025
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    Whitehawk Completes Sale of Aadi Subsidiary to Kaken Pharma
    Whitehawk Completes Sale of Aadi Subsidiary to Kaken Pharma

    26 Mar 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/whitehawk-therapeutics-completes-strategic-transformation-with-successful-closing-of-sale-of-aadi-subsidiary-to-kaken-pharmaceuticals-302411424.html

    PR NEWSWIRE
    26 Mar 2025
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    Alumis and Kaken Pharma Collaborate on ESK-001 in Japan
    Alumis and Kaken Pharma Collaborate on ESK-001 in Japan

    25 Mar 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/03/25/3048418/0/en/Alumis-and-Kaken-Pharmaceutical-Announce-Collaboration-and-Licensing-Agreement-for-ESK-001-in-Dermatology-in-Japan.html

    GLOBENEWSWIRE
    25 Mar 2025
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    Kaken, J&J ink potential $1.2B-plus STAT6 deal
    Kaken, J&J ink potential $1.2B-plus STAT6 deal

    28 Dec 2024

    // PRESS RELEASE

    https://www.jnj.com/media-center/press-releases/johnson-johnson-to-license-novel-oral-assets-further-strengthening-commitment-to-atopic-dermatitis

    PRESS RELEASE
    28 Dec 2024
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    bitBiome and Kaken sign agreement on discovery of drugs for infectious diseases
    bitBiome and Kaken sign agreement on discovery of drugs for infectious diseases

    29 Mar 2023

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/bitbiome-and-kaken-pharmaceuticals-sign-joint-research-agreement-on-the-discovery-of-drugs-for-infectious-diseases-301781763.html

    PR NEWSWIRE
    29 Mar 2023
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    ALL APIs

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    read-moreClick the button for full data set

    01

    Butenafine Hydrochloride

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Coatings Trends
    Not Confirmed
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    Butenafine Hydrochloride

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Coatings Trends
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 11296

    Submission : 1995-01-09

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF10389

    Registrant's Address : 2-28-8 Honkomagome, Bunkyo-ku, Tokyo

    Initial Date of Registration : 2005-07-27

    Latest Date of Registration :

    EU-WC NDC arrow-down
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    NDC Package Code : 51265-363

    Start Marketing Date : 1996-12-31

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2023-03-23

    Registration Number : 20230323-211-J-1455

    Manufacturer Name : Kaken Pharmaceutical Co., Ltd. Shizuoka Factory

    Manufacturer Address : 301-banchi, Gensuke, Fujieda-City, Shizuoka 426-8646, Japan

     VMF Others AUDIT
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    02

    Dofetilide

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Coatings Trends
    Not Confirmed
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    Dofetilide

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Coatings Trends
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    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 30794

    Submission : 2018-05-30

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    03

    Efinaconazole

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Coatings Trends
    Not Confirmed
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    Efinaconazole

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Coatings Trends
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21870

    Submission : 2008-07-25

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    04

    Efinaconazole

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Coatings Trends
    Not Confirmed
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    Efinaconazole

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Coatings Trends
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 27081

    Submission : 2013-05-24

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Stock Recap
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    05

    Efinaconazole

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Coatings Trends
    Not Confirmed
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    Efinaconazole

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Coatings Trends
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37590

    Submission : 2022-12-02

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    06

    Sofpironium Bromide

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Coatings Trends
    Not Confirmed
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    Sofpironium Bromide

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 31310

    Submission : 2017-09-22

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    07

    Medium / medium additive · bFGF So...

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Coatings Trends
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    Medium / medium additive · bFGF So...

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Coatings Trends
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 228MF40013

    Registrant's Address : 2-28-8 Honkomagome, Bunkyo-ku, Tokyo

    Initial Date of Registration : 2016-05-26

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    08

    Pronase

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Coatings Trends
    Not Confirmed
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    Pronase

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Coatings Trends
    Not Confirmed
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    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF10390

    Registrant's Address : 2-28-8 Honkomagome, Bunkyo-ku, Tokyo

    Initial Date of Registration : 2005-07-27

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    09

    Efinaconazole

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Coatings Trends
    Not Confirmed
    arrow

    Efinaconazole

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Coatings Trends
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20533

    Submission : 2007-05-01

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    10

    Pralmorelin

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Coatings Trends
    Not Confirmed
    arrow

    Pralmorelin

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Coatings Trends
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10256

    Submission : 1993-05-24

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    USDMF

    read-more
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    01

    Buteneafine Hydrochloride

    Japan
    Coatings Trends
    Not Confirmed
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    02

    Efinaconazole

    Japan
    Coatings Trends
    Not Confirmed
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    03

    Efinaconazole\k

    Japan
    Coatings Trends
    Not Confirmed
    arrow

    04

    Kp-102

    Japan
    Coatings Trends
    Not Confirmed
    arrow

    05

    Kp-103

    Japan
    Coatings Trends
    Not Confirmed
    arrow

    06

    Kp-103/b

    Japan
    Coatings Trends
    Not Confirmed
    arrow

    07

    Kp-470

    Japan
    Coatings Trends
    Not Confirmed
    arrow

    08

    Sofpironium Bromide

    Japan
    Coatings Trends
    Not Confirmed
    arrow

    09

    Kp-413 Drug Submstance

    Japan
    Coatings Trends
    Not Confirmed
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    10

    Manufacturing Site, Facilities, Pers...

    Japan
    Coatings Trends
    Not Confirmed
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    Manufacturing Site, Facilities, Pers...

    Japan
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    Not Confirmed
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    Kaken Pharmaceuticals

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 11297

    Submission : 1995-01-09

    Status : Inactive

    Type : II

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    Drugs in Development

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    KalVista Licenses Sebetralstat to Kaken for HAE Market in Japan

    Details:

    Under the licensing agreement, Kaken will holds the rights of KVD900 (sebetralstat) in Japan. It is being evaluated for the treatment of hereditary angioedema.


    Lead Product(s): Sebetralstat,Inapplicable

    Therapeutic Area: Genetic Disease Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Recipient: KalVista Pharmaceuticals

    Deal Size: $22.0 million Upfront Cash: $11.0 million

    Deal Type: Licensing Agreement April 08, 2025

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    01

    Kaken Pharmaceuticals

    Japan
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    Coatings Trends
    Not Confirmed

    Kaken Pharmaceuticals

    Japan
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    Coatings Trends
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    Lead Product(s) : Sebetralstat,Inapplicable

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase III

    Recipient : KalVista Pharmaceuticals

    Deal Size : $22.0 million

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    KalVista Licenses Sebetralstat to Kaken for HAE Market in Japan

    Details : Under the licensing agreement, Kaken will holds the rights of KVD900 (sebetralstat) in Japan. It is being evaluated for the treatment of hereditary angioedema.

    Product Name : Undisclosed

    Product Type : Other Small Molecule

    Upfront Cash : $11.0 million

    April 08, 2025

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    Whitehawk Finalizes Aadi Sale To Kaken In Strategic Transformation

    Details:

    Through the divestment, Kaken assumes ownership of FYARRO (sirolimus protein-bound particles for injectable suspension) used to treat adults with malignant perivascular epithelioid cell tumor.


    Lead Product(s): Sirolimus Protein-bound Particle,Inapplicable

    Therapeutic Area: Oncology Brand Name: Fyarro

    Study Phase: Approved FDFProduct Type: Antibiotic

    Recipient: Whitehawk Therapeutics

    Deal Size: $100.0 million Upfront Cash: $100.0 million

    Deal Type: Divestment March 26, 2025

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    02

    Kaken Pharmaceuticals

    Japan
    arrow
    Coatings Trends
    Not Confirmed

    Kaken Pharmaceuticals

    Japan
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    Coatings Trends
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    Lead Product(s) : Sirolimus Protein-bound Particle,Inapplicable

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Recipient : Whitehawk Therapeutics

    Deal Size : $100.0 million

    Deal Type : Divestment

    DEALS_DEV arrow-down

    Whitehawk Finalizes Aadi Sale To Kaken In Strategic Transformation

    Details : Through the divestment, Kaken assumes ownership of FYARRO (sirolimus protein-bound particles for injectable suspension) used to treat adults with malignant perivascular epithelioid cell tumor.

    Product Name : Fyarro

    Product Type : Antibiotic

    Upfront Cash : $100.0 million

    March 26, 2025

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    Alumis, Kaken Partner on ESK-001 for Dermatology in Japan

    Details:

    The collaboration aims to develop, manufacture and commercialize ESK-001, a highly selective, next-gen oral TYK2 inhibitor, for dermatology indications in Japan.


    Lead Product(s): ESK-001,Inapplicable

    Therapeutic Area: Dermatology Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Recipient: Alumis

    Deal Size: $180.0 million Upfront Cash: $40.0 million

    Deal Type: Collaboration March 25, 2025

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    03

    Kaken Pharmaceuticals

    Japan
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    Coatings Trends
    Not Confirmed

    Kaken Pharmaceuticals

    Japan
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    Coatings Trends
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    Lead Product(s) : ESK-001,Inapplicable

    Therapeutic Area : Dermatology

    Highest Development Status : Phase III

    Recipient : Alumis

    Deal Size : $180.0 million

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Alumis, Kaken Partner on ESK-001 for Dermatology in Japan

    Details : The collaboration aims to develop, manufacture and commercialize ESK-001, a highly selective, next-gen oral TYK2 inhibitor, for dermatology indications in Japan.

    Product Name : Undisclosed

    Product Type : Other Small Molecule

    Upfront Cash : $40.0 million

    March 25, 2025

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    Kaken, J&J Ink Potential $1.2B-Plus STAT6 Deal

    Details:

    Johnson gains an exclusive license to Kaken’s STAT6 program, including lead candidate KP-723, a preclinical STAT6 inhibitor, for autoimmune and allergic diseases, including atopic dermatitis.


    Lead Product(s): KP-723,Inapplicable

    Therapeutic Area: Dermatology Brand Name: Undisclosed

    Study Phase: PreclinicalProduct Type: Other Small Molecule

    Sponsor: Johnson & Johnson

    Deal Size: $1,247.5 million Upfront Cash: $30.0 million

    Deal Type: Licensing Agreement December 26, 2024

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    04

    Kaken Pharmaceuticals

    Japan
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    Coatings Trends
    Not Confirmed

    Kaken Pharmaceuticals

    Japan
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    Coatings Trends
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    Lead Product(s) : KP-723,Inapplicable

    Therapeutic Area : Dermatology

    Highest Development Status : Preclinical

    Partner/Sponsor/Collaborator : Johnson & Johnson

    Deal Size : $1,247.5 million

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Kaken, J&J Ink Potential $1.2B-Plus STAT6 Deal

    Details : Johnson gains an exclusive license to Kaken’s STAT6 program, including lead candidate KP-723, a preclinical STAT6 inhibitor, for autoimmune and allergic diseases, including atopic dermatitis.

    Product Name : Undisclosed

    Product Type : Other Small Molecule

    Upfront Cash : $30.0 million

    December 26, 2024

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    Numab and Kaken Collaborate On ND081 for Inflammatory Bowel Disease

    Details:

    The collaboration aims to develop ND081, a potential first-in-class multi-specific antibody for the treatment of inflammatory bowel disease (IBD).


    Lead Product(s): ND081,Inapplicable

    Therapeutic Area: Gastroenterology Brand Name: Undisclosed

    Study Phase: PreclinicalProduct Type: Other Large Molecule

    Recipient: Numab Therapeutics

    Deal Size: Undisclosed Upfront Cash: $14.6 million

    Deal Type: Collaboration November 15, 2024

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    05

    Kaken Pharmaceuticals

    Japan
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    Coatings Trends
    Not Confirmed

    Kaken Pharmaceuticals

    Japan
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    Coatings Trends
    Not Confirmed
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    Lead Product(s) : ND081,Inapplicable

    Therapeutic Area : Gastroenterology

    Highest Development Status : Preclinical

    Recipient : Numab Therapeutics

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Numab and Kaken Collaborate On ND081 for Inflammatory Bowel Disease

    Details : The collaboration aims to develop ND081, a potential first-in-class multi-specific antibody for the treatment of inflammatory bowel disease (IBD).

    Product Name : Undisclosed

    Product Type : Other Large Molecule

    Upfront Cash : $14.6 million

    November 15, 2024

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    Eisai to Divest Rights for Merislon and Myonal in Japan to Kaken Pharmaceutical

    Details:

    Eisai divested its rights for Merislon (betahistine mesilate), used to treat Meniere's syndrome, and muscle relaxant Myonal (eperisone hydrochloride) in Japan to Kaken.


    Lead Product(s): Betahistine Dimesilate,Inapplicable

    Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Merislon

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Recipient: Eisai

    Deal Size: $25.0 million Upfront Cash: Undisclosed

    Deal Type: Divestment March 29, 2024

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    06

    Kaken Pharmaceuticals

    Japan
    arrow
    Coatings Trends
    Not Confirmed

    Kaken Pharmaceuticals

    Japan
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    Coatings Trends
    Not Confirmed
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    Lead Product(s) : Betahistine Dimesilate,Inapplicable

    Therapeutic Area : Otolaryngology (Ear, Nose, Throat)

    Highest Development Status : Approved FDF

    Recipient : Eisai

    Deal Size : $25.0 million

    Deal Type : Divestment

    DEALS_DEV arrow-down

    Eisai to Divest Rights for Merislon and Myonal in Japan to Kaken Pharmaceutical

    Details : Eisai divested its rights for Merislon (betahistine mesilate), used to treat Meniere's syndrome, and muscle relaxant Myonal (eperisone hydrochloride) in Japan to Kaken.

    Product Name : Merislon

    Product Type : Other Small Molecule

    Upfront Cash : Undisclosed

    March 29, 2024

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    CymaBay Therapeutics Announces Collaboration with Kaken Pharmaceutical Co., Ltd. to Develop and Commercialize Seladelpar in Japan for Primary Biliary Ch...

    Details:

    Under the terms of the agreement, Kaken receives an exclusive license to develop, commercialize and market MBX-8025 (seladelpar), a first-in-class treatment for people with primary biliary cholangitis (PBC), in Japan for PBC.


    Lead Product(s): Seladelpar Lysine,Inapplicable

    Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Recipient: CymaBay Therapeutics

    Deal Size: $162.4 million Upfront Cash: $34.0 million

    Deal Type: Collaboration August 01, 2023

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    07

    Kaken Pharmaceuticals

    Japan
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    Coatings Trends
    Not Confirmed

    Kaken Pharmaceuticals

    Japan
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    Lead Product(s) : Seladelpar Lysine,Inapplicable

    Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)

    Highest Development Status : Phase III

    Recipient : CymaBay Therapeutics

    Deal Size : $162.4 million

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    CymaBay Therapeutics Announces Collaboration with Kaken Pharmaceutical Co., Ltd. to Develop and Co...

    Details : Under the terms of the agreement, Kaken receives an exclusive license to develop, commercialize and market MBX-8025 (seladelpar), a first-in-class treatment for people with primary biliary cholangitis (PBC), in Japan for PBC.

    Product Name : Undisclosed

    Product Type : Other Small Molecule

    Upfront Cash : $34.0 million

    August 01, 2023

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    Numab Therapeutics Announces First Subject Dosed in Phase 1 Clinical Study of NM26 Program

    Details:

    NM26-2198 is a bi-specific antibody which targets IL-4Rα (type I and type II receptors) and IL-31 for the treatment of moderate-to-severe atopic dermatitis (AD).


    Lead Product(s): NM26-2198,Inapplicable

    Therapeutic Area: Dermatology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Antibody

    Recipient: Numab Therapeutics

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 15, 2023

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    08

    Kaken Pharmaceuticals

    Japan
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    Kaken Pharmaceuticals

    Japan
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    Lead Product(s) : NM26-2198,Inapplicable

    Therapeutic Area : Dermatology

    Highest Development Status : Phase I

    Recipient : Numab Therapeutics

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Numab Therapeutics Announces First Subject Dosed in Phase 1 Clinical Study of NM26 Program

    Details : NM26-2198 is a bi-specific antibody which targets IL-4Rα (type I and type II receptors) and IL-31 for the treatment of moderate-to-severe atopic dermatitis (AD).

    Product Name : Undisclosed

    Product Type : Antibody

    Upfront Cash : Inapplicable

    May 15, 2023

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    Spruce Biosciences and Kaken Pharmaceutical Announce Strategic Partnership and Exclusive Licensing Agreement to Develop and Commercialize Tildacerfont f...

    Details:

    SPR001 (tildacerfont) is a potent and highly selective, non-steroidal, oral antagonist of the corticotropin-releasing factor (CRF) 1 receptor. The CRF1 receptor is abundantly expressed in the pituitary gland where it is the primary regulator of the HPA axis.


    Lead Product(s): Tildacerfont,Inapplicable

    Therapeutic Area: Genetic Disease Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Other Small Molecule

    Recipient: Spruce Biosciences

    Deal Size: Undisclosed Upfront Cash: $15.0 million

    Deal Type: Partnership May 01, 2023

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    09

    Kaken Pharmaceuticals

    Japan
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    Kaken Pharmaceuticals

    Japan
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    Lead Product(s) : Tildacerfont,Inapplicable

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase II

    Recipient : Spruce Biosciences

    Deal Size : Undisclosed

    Deal Type : Partnership

    DEALS_DEV arrow-down

    Spruce Biosciences and Kaken Pharmaceutical Announce Strategic Partnership and Exclusive Licensing...

    Details : SPR001 (tildacerfont) is a potent and highly selective, non-steroidal, oral antagonist of the corticotropin-releasing factor (CRF) 1 receptor. The CRF1 receptor is abundantly expressed in the pituitary gland where it is the primary regulator of the HPA a...

    Product Name : Undisclosed

    Product Type : Other Small Molecule

    Upfront Cash : $15.0 million

    May 01, 2023

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    bitBiome and Kaken Pharmaceuticals Sign Joint Research Agreement on The Discovery of Drugs for Infectious Diseases

    Details:

    Under the agreement, the companies will utilize the microbial platform technology developed by bitBiome to obtain drug candidates for the treatment of infectious diseases with high unmet medical needs.


    Lead Product(s): Undisclosed,Inapplicable

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: DiscoveryProduct Type: Undisclosed

    Recipient: bitBiome

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement March 29, 2023

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    10

    Kaken Pharmaceuticals

    Japan
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    Kaken Pharmaceuticals

    Japan
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    Lead Product(s) : Undisclosed,Inapplicable

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Discovery

    Recipient : bitBiome

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    bitBiome and Kaken Pharmaceuticals Sign Joint Research Agreement on The Discovery of Drugs for Inf...

    Details : Under the agreement, the companies will utilize the microbial platform technology developed by bitBiome to obtain drug candidates for the treatment of infectious diseases with high unmet medical needs.

    Product Name : Undisclosed

    Product Type : Undisclosed

    Upfront Cash : Undisclosed

    March 29, 2023

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