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ACTIVE PHARMA INGREDIENTS

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Chemistry

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Also known as: 1628106-94-4, Sofpironium (bromide), Bbi-4000, Sofpironium bromide [usan], 7b2y1932xu, (3r)-3-((r)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1-(2-ethoxy-2-oxoethyl)-1-methylpyrrolidin-1-ium bromide
Molecular Formula
C22H32BrNO5
Molecular Weight
470.4  g/mol
InChI Key
FIAFMTCUJCWADZ-JOFREBOKSA-M
FDA UNII
7B2Y1932XU

Sofpironium Bromide
1 2D Structure

Sofpironium Bromide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(3R)-1-(2-ethoxy-2-oxoethyl)-1-methylpyrrolidin-1-ium-3-yl] (2R)-2-cyclopentyl-2-hydroxy-2-phenylacetate;bromide
2.1.2 InChI
InChI=1S/C22H32NO5.BrH/c1-3-27-20(24)16-23(2)14-13-19(15-23)28-21(25)22(26,18-11-7-8-12-18)17-9-5-4-6-10-17;/h4-6,9-10,18-19,26H,3,7-8,11-16H2,1-2H3;1H/q+1;/p-1/t19-,22+,23?;/m1./s1
2.1.3 InChI Key
FIAFMTCUJCWADZ-JOFREBOKSA-M
2.1.4 Canonical SMILES
CCOC(=O)C[N+]1(CCC(C1)OC(=O)C(C2CCCC2)(C3=CC=CC=C3)O)C.[Br-]
2.1.5 Isomeric SMILES
CCOC(=O)C[N+]1(CC[C@H](C1)OC(=O)[C@@](C2CCCC2)(C3=CC=CC=C3)O)C.[Br-]
2.2 Other Identifiers
2.2.1 UNII
7B2Y1932XU
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. 1628106-94-4

2. Sofpironium (bromide)

3. Bbi-4000

4. Sofpironium Bromide [usan]

5. 7b2y1932xu

6. (3r)-3-((r)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1-(2-ethoxy-2-oxoethyl)-1-methylpyrrolidin-1-ium Bromide

7. Pyrrolidinium, 3-(((2r)-2-cyclopentyl-2-hydroxy-2-phenylacetyl)oxy)-1-(2-ethoxy-2-oxoethyl)-1-methyl-, Bromide (1:1), (3r)-

8. Starbld0007908

9. Unii-7b2y1932xu

10. Chembl3707223

11. Schembl20995843

12. Sofpironium Bromide [inn]

13. Sofpironium Bromide [jan]

14. Ex-a5238

15. Sofpironium Bromide [who-dd]

16. Sofpironium Bromide (jan/usan/inn)

17. Hy-109013

18. Cs-0030511

19. D10989

20. Q27268000

21. 1-ambo-(3r)-3-(((r)-(cyclopentyl)hydroxy(phenyl) Acetyl)oxy)-1-(2-ethoxy-2-oxoethyl)-1-methylpyrrolidinium Bromide Anticholinergic

2.4 Create Date
2014-12-31
3 Chemical and Physical Properties
Molecular Weight 470.4 g/mol
Molecular Formula C22H32BrNO5
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count6
Rotatable Bond Count9
Exact Mass469.14639 g/mol
Monoisotopic Mass469.14639 g/mol
Topological Polar Surface Area72.8 Ų
Heavy Atom Count29
Formal Charge0
Complexity555
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

NDC API

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SOFPIRONIUM BROMIDE

NDC Package Code : 68259-1318

Start Marketing Date : 2024-12-17

End Marketing Date : 2026-12-31

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

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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Virtual BoothMaithri Drugs: Dedicated to your API needs.

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Sofpironium Bromide

About the Company : Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, ant...

Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, antibiotics, ARVs, CNS, and cardiovascular segments. The company operates facilities approved by US FDA, EDQM, Health Canada, and WHO-GMP, supported by multiple global DMFs and Ecovadis recognition. Backed by strong R&D, global patents, and customer-focused practices, Maithri delivers high-quality APIs with regulatory excellence. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Sofpironium Bromide

About the Company : Harman Finochem Limited is a leading India-based Pharmaceutical Company which specializes in the manufacture and export of more than 45 Active Pharmaceutical Ingredients (APls) of ...

Harman Finochem Limited is a leading India-based Pharmaceutical Company which specializes in the manufacture and export of more than 45 Active Pharmaceutical Ingredients (APls) of which 10 are Essential Drugs as per the WHO Model List. We deliver top quality products to more than 35 countries across the globe. Harman Finochem ensures that its customers worldwide are delighted by receiving APl’s which are safe, efficient and of highest quality. We adhere to principles of cGmp and our team at all levels is committed to achieving this corporate excellence goal.
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Drugs in Development

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Details:

Sofdra (sofpironium) works by inhibiting M3 muscarinic receptors in eccrine glands. It is approved for the treatment of primary axillary hyperhidrosis in patients ages 9 and older.


Lead Product(s): Sofpironium Bromide,Inapplicable

Therapeutic Area: Dermatology Brand Name: Sofdra

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 20, 2024

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Botanix Pharma

Australia
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Botanix Pharma

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Details : Sofdra (sofpironium) works by inhibiting M3 muscarinic receptors in eccrine glands. It is approved for the treatment of primary axillary hyperhidrosis in patients ages 9 and older.

Product Name : Sofdra

Product Type : Miscellaneous

Upfront Cash : Inapplicable

June 20, 2024

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Details:

Under the agreement, Fresh Tracks provided consulting services as an independent contractor to Botanix in support of and through filing and approval of the U.S. new drug application for BBI-4000 (sofpironium bromide gel).


Lead Product(s): Sofpironium Bromide,Inapplicable

Therapeutic Area: Dermatology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Botanix Pharma

Deal Size: $8.2 million Upfront Cash: $8.2 million

Deal Type: Agreement July 21, 2023

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Details : Under the agreement, Fresh Tracks provided consulting services as an independent contractor to Botanix in support of and through filing and approval of the U.S. new drug application for BBI-4000 (sofpironium bromide gel).

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : $8.2 million

July 21, 2023

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Details:

The results from the Cardigan I and Cardigan II studies, along with all previously completed clinical studies, will form the basis for a U.S. NDA for sofpironium bromide gel, 15%, which is expected to submit to the FDA in mid-2022.


Lead Product(s): Sofpironium Bromide,Inapplicable

Therapeutic Area: Dermatology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 07, 2021

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Details : The results from the Cardigan I and Cardigan II studies, along with all previously completed clinical studies, will form the basis for a U.S. NDA for sofpironium bromide gel, 15%, which is expected to submit to the FDA in mid-2022.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 07, 2021

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Details:

Sofpironium bromide is Brickell’s lead investigational product candidate and is a new chemical entity that belongs to a class of medications called anticholinergics.


Lead Product(s): Sofpironium Bromide,Inapplicable

Therapeutic Area: Dermatology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: H.C. Wainwright & Co

Deal Size: $8.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering July 22, 2021

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Lead Product(s) : Sofpironium Bromide,Inapplicable

Therapeutic Area : Dermatology

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : H.C. Wainwright & Co

Deal Size : $8.0 million

Deal Type : Public Offering

Details : Sofpironium bromide is Brickell’s lead investigational product candidate and is a new chemical entity that belongs to a class of medications called anticholinergics.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Undisclosed

July 22, 2021

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Details:

Brickell Biotech completed patient enrollment in the Phase 3 pivotal Cardigan I study and that the Cardigan II study has surpassed 50% enrollment. Both studies are evaluating sofpironium bromide gel, 15% in patients with primary axillary (underarm) hyperhidrosis.


Lead Product(s): Sofpironium Bromide,Inapplicable

Therapeutic Area: Dermatology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 27, 2021

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Details : Brickell Biotech completed patient enrollment in the Phase 3 pivotal Cardigan I study and that the Cardigan II study has surpassed 50% enrollment. Both studies are evaluating sofpironium bromide gel, 15% in patients with primary axillary (underarm) hyper...

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

April 27, 2021

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Details:

The ARGYLE study assessed the long-term safety and efficacy of topical, once-daily treatment with sofpironium bromide gel, 5% and 15% for 48 weeks in patients nine years and older with primary axillary hyperhidrosis/excessive underarm sweating.


Lead Product(s): Sofpironium Bromide,Inapplicable

Therapeutic Area: Dermatology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 23, 2021

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Details : The ARGYLE study assessed the long-term safety and efficacy of topical, once-daily treatment with sofpironium bromide gel, 5% and 15% for 48 weeks in patients nine years and older with primary axillary hyperhidrosis/excessive underarm sweating.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

April 23, 2021

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Details:

First patient in its second U.S. pivotal Phase 3 clinical study (“Cardigan II study”) evaluating sofpironium bromide gel, 15% in approximately 350 subjects aged nine and older with primary axillary (underarm) hyperhidrosis.


Lead Product(s): Sofpironium Bromide,Inapplicable

Therapeutic Area: Dermatology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 07, 2020

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Details : First patient in its second U.S. pivotal Phase 3 clinical study (“Cardigan II study”) evaluating sofpironium bromide gel, 15% in approximately 350 subjects aged nine and older with primary axillary (underarm) hyperhidrosis.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 07, 2020

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Details:

The Cardigan I Study is a multicenter, randomized, double-blinded, vehicle (placebo)-controlled Phase 3 study to evaluate the safety and efficacy of topically applied sofpironium bromide gel, 15%.


Lead Product(s): Sofpironium Bromide,Inapplicable

Therapeutic Area: Dermatology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 06, 2020

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Details : The Cardigan I Study is a multicenter, randomized, double-blinded, vehicle (placebo)-controlled Phase 3 study to evaluate the safety and efficacy of topically applied sofpironium bromide gel, 15%.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 06, 2020

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Details:

Sofpironium bromide gel was deemed to be safe and well tolerated in this study, as well as in the accompanying 52-week long-term safety extension study in Japan. Japan is the first country to approve sofpironium bromide with commercial launch expected later this year.


Lead Product(s): Sofpironium Bromide,Inapplicable

Therapeutic Area: Dermatology Brand Name: Ecclock

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Fresh Tracks Therapeutics

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 25, 2020

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Details : Sofpironium bromide gel was deemed to be safe and well tolerated in this study, as well as in the accompanying 52-week long-term safety extension study in Japan. Japan is the first country to approve sofpironium bromide with commercial launch expected la...

Product Name : Ecclock

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 25, 2020

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Details:

Brickell and Kaken Pharmaceutical were granted by the Japanese Patent Office a composition of matter patent with claims directed to the novel polymorphic, or crystalline, forms of sofpironium bromide, a retrometabolically designed new chemical entity.


Lead Product(s): Sofpironium Bromide,Inapplicable

Therapeutic Area: Dermatology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Kaken Pharmaceuticals

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 31, 2020

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ELCC
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Details : Brickell and Kaken Pharmaceutical were granted by the Japanese Patent Office a composition of matter patent with claims directed to the novel polymorphic, or crystalline, forms of sofpironium bromide, a retrometabolically designed new chemical entity.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 31, 2020

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FDF Dossiers

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Botanix Pharma

Australia
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SOFPIRONIUM BROMIDE

Brand Name : SOFDRA

Dosage Form : GEL, METERED;TOPICAL

Dosage Strength : EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)

Packaging :

Approval Date : 2024-06-18

Application Number : 217347

Regulatory Info : RX

Registration Country : USA

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DATA COMPILATION #PharmaFlow

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FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies
In 2024, the biopharma industry continued to advance on its robust trajectory of innovation. Though the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) approved fewer drugs, there was a significant increase in medical breakthroughs.While the CDER approved 50 new drugs in 2024, as compared to 55 in 2023, the CBER granted 14 biologics approvals in 2024, down from 20 in 2023.The European Medicines Agency (EMA) approved 34 new therapies, up from 32 in 2023, while Health Canada granted 28 approvals, down from 38 in 2023.The year saw long-awaited treatments being approved in areas such as schizophrenia and Alzheimer’s disease in the second half (H2) of 2024. In H1 2024, drugs to treat metabolic dysfunction-associated steatohepatitis (MASH) and chronic obstructive pulmonary disease (COPD) had been granted FDA approvals.As the year drew to a close, FDA began approving drugs at a feverish pace, with 29 of the CDER’s 50 approvals coming in H2.Like most years, the landscape of drug approvals was dominated by oncology, with 15 of the 50 drugs (30 percent) approved targeting various forms of cancer. This was followed by dermatology and non-malignant hematology, each accounting for 12 percent of approvals. Notably, small molecules continued to dominate the market, making up for 64 percent of the new drug approvals, while 32 percent were proteins, including monoclonal and bi-specific antibodies. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available)Karuna-BMS’ schizophrenia drug, Lilly’s Alzheimer’s med, Neurocrine’s Crenessity dominate list of pathbreaking approvals in H2Out of the 50 new drugs approved in 2024, CDER identified 24 (48 percent) as first-in-class, showcasing novel mechanisms of action. The most anticipated approval of 2024 was Karuna and Bristol Myers Squibb’s Cobenfy, a groundbreaking treatment for schizophrenia. This fixed-dose combination of xanomeline and trospium chloride represents the first novel mechanism of action in decades for this debilitating psychiatric condition. Analysts forecast peak annual sales of over US$ 3.3 billion for Cobenfy. Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) became the third amyloid-targeting antibody to gain FDA approval. Unlike its predecessors, Kisunla offers a unique limited-duration treatment regimen, allowing patients to discontinue therapy once amyloid levels in the brain drop below a certain threshold. Priced at approximately US$ 32,000 per year, it is positioned as a cost-effective alternative to existing treatments. Analysts estimate peak sales of US$ 2.4 billion for Kisunla.Crenessity (crinecerfont), developed by Neurocrine Biosciences, became the first FDA-approved treatment in decades for classic congenital adrenal hyperplasia (genetic conditions that affect the adrenal glands). Similarly, Vertex’s triple combination therapy of deutivacaftor, tezacaftor & vanzacaftor (Alyftrek) for cystic fibrosis represents a significant advancement in genetic disease treatment. Analysts forecast peak sales exceeding US$ 8.3 billion, underscoring the therapy’s potential to transform patient care.Meanwhile, Bridgebio’s Attruby (acoramidis hydrochloride) emerged as a promising treatment for cardiac amyloidosis, a life-threatening condition. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Roche’s Itovebi, Checkpoint’s Unloxcyt clinch FDA approvals in H2 2024; forecast to achieve blockbuster statusThe dominance of cancer drug approvals reflects the ongoing focus on targeted therapies, immuno-oncology, and precision medicine to improve outcomes for patients with hard-to-treat cancers.Among the year’s notable FDA approvals was Genentech’s Itovebi (inavolisib), another targeted therapy that treats hormone receptor-positive (HR+), HER2-negative breast cancer. Itovebi is a PI3Kα inhibitor designed specifically for patients with PIK3CA mutations, a common driver of resistance to endocrine therapy in breast cancer. It demonstrated a more tolerable safety profile. Roche projects Itovebi’s peak (annual) sales to reach CHF 2 billion (US$ 2.3 billion).Checkpoint Therapeutics’ Unloxcyt (cosibelimab) joined the crowded checkpoint inhibitor market as the eleventh PD-1/PD-L1-targeting monoclonal antibody approved by the FDA. It was granted approval for cutaneous squamous cell carcinoma (cSCC), an aggressive form of skin cancer with high recurrence rates. As compared to other checkpoint inhibitors, like Keytruda (pembrolizumab) and Opdivo (nivolumab), Unloxcyt is likely to offer an advantage in immune activation.FDA also approved Astellas’ Vyloy (zolbetuximab), a first-in-class monoclonal antibody for metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Analysts forecast peak sales of approximately US$ 850 million for Vyloy.Syndax Pharmaceuticals’ Revuforj (revumenib) was approved by FDA to treat a type of acute leukemia in both adults and children. This approval introduces a novel class of medications known as menin inhibitors. These agents are currently in clinical development for the treatment of genetically defined subsets of acute leukemia. These inhibitors function by preventing the activation of cancer growth-related proteins. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Potential blockbusters Lilly’s Ebglyss, Galderma’s Nemluvio lead advances in dermatologyEli Lilly’s Ebglyss (lebrikizumab) garnered significant attention. Approved by FDA for moderate-to-severe atopic dermatitis, this monoclonal antibody introduces a less burdensome dosing regimen compared to its competitors, with maintenance therapy required only once a month. This feature positions it as a potential contender to Dupixent (dupilumab), a market leader in atopic dermatitis. Ebglyss sales are forecast to reach US$ 1.9 billion by 2030.Galderma’s Nemluvio (nemolizumab) secured FDA approval for two indications in 2024 — prurigo nodularis (a chronic disorder of the skin) and moderate-to-severe atopic dermatitis in patients aged 12 years and older. As the first humanized IgG2 monoclonal antibody targeting the IL-31 receptor, Nemluvio directly inhibits the key driver of itch and inflammation in both these conditions. With its unique mechanism and broad dermatology potential, analysts forecast peak sales of approximately US$ 1.66 billion. Ebglyss and Nemluvio underscore the growing importance of biologics in dermatological care.Botanix Pharmaceuticals also made strides in dermatology by clinching an FDA approval for Sofdra (sofpironium) in June. The drug has been okayed for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive sweating.Ascendis Pharma’s Yorvipath (palopegteriparatide), a therapy approved by FDA to treat hypoparathyroidism, is forecast to achieve blockbuster sales of US$ 1.8 billion by 2030, highlighting its potential to transform endocrine care. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Our viewOverall, 2024 was defined by its breakthrough drug approvals. The year also saw significant reduction in complete response letters (CRLs) — they dropped from 43 in 2023 to just 29 in 2024. This suggests improved industry preparedness and alignment with regulatory expectations.The new year began with the approval of Datroway (datopotamab deruxtecan) from AstraZeneca and Daiichi Sankyo, marking a significant advancement in oncology. Several other promising new drugs are coming up for FDA approval this year, such as J&J’s nipocalimab, Vertex Pharmaceuticals’ suzetrigine, Elevar Therapeutics’ rivoceranib/camrelizumab, Sanofi’s fitusiran and GSK’s gepotidacin. Hopefully, the momentum of breakthrough approvals will continue through 2025, political headwinds in the US notwithstanding. 

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https://www.pharmacompass.com/radio-compass-blog/fda-okays-50-new-drugs-in-2024-bms-cobenfy-lilly-s-kisunla-lead-pack-of-breakthrough-therapies

#PharmaFlow by PHARMACOMPASS
30 Jan 2025

NEWS #PharmaBuzz

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https://www.fiercepharma.com/pharma/no-sweat-dermatology-drugmaker-botanix-fda-approval-hyperhidrosis-gel-sofdra

Zoey Becker FIERCE PHARMA
21 Jun 2024

https://www.troutman.com/insights/troutman-pepper-advises-clinical-dermatology-company-botanix-pharmaceuticals-in-acquisition-of-sofpironium-bromide.html

TROUTMAN
04 May 2022

https://www.globenewswire.com/news-release/2021/08/16/2281087/0/en/Brickell-Biotech-Announces-Final-Patient-Completed-Second-U-S-Phase-3-Pivotal-Clinical-Study-of-Sofpironium-Bromide-Gel-15-for-the-Treatment-of-Primary-Axillary-Hyperhidrosis.html

GLOBENEWSWIRE
16 Aug 2021

https://www.globenewswire.com/news-release/2021/06/29/2255171/0/en/Brickell-Biotech-Announces-Final-Patient-Completed-in-First-U-S-Phase-3-Pivotal-Clinical-Study-and-Patient-Enrollment-Completed-in-Second-U-S-Phase-3-Pivotal-Clinical-Study-of-Sofp.html

GLOBENEWSWIRE
29 Jun 2021

https://www.globenewswire.com/news-release/2020/11/18/2129056/0/en/Brickell-Biotech-Announces-Launch-Date-for-Sofpironium-Bromide-Gel-5-ECCLOCK-in-Japan-by-its-Development-Partner-Kaken-Pharmaceutical.html

GLOBENEWSWIRE
18 Nov 2020

https://seekingalpha.com/pr/18020127-brickell-biotech-announces-approval-of-sofpironium-bromide-gel-5-in-japan-for-treatment-of

Vandana Singh SEEKING ALPHA
25 Sep 2020

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API | Excipient name

Sofpironium Bromide

Synonyms

1628106-94-4, Sofpironium (bromide), Bbi-4000, Sofpironium bromide [usan], 7b2y1932xu, (3r)-3-((r)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1-(2-ethoxy-2-oxoethyl)-1-methylpyrrolidin-1-ium bromide

Cas Number

1628106-94-4

Unique Ingredient Identifier (UNII)

7B2Y1932XU

Sofpironium Bromide Manufacturers

A Sofpironium Bromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sofpironium Bromide, including repackagers and relabelers. The FDA regulates Sofpironium Bromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sofpironium Bromide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Sofpironium Bromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Sofpironium Bromide Suppliers

A Sofpironium Bromide supplier is an individual or a company that provides Sofpironium Bromide active pharmaceutical ingredient (API) or Sofpironium Bromide finished formulations upon request. The Sofpironium Bromide suppliers may include Sofpironium Bromide API manufacturers, exporters, distributors and traders.

click here to find a list of Sofpironium Bromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Sofpironium Bromide USDMF

A Sofpironium Bromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Sofpironium Bromide active pharmaceutical ingredient (API) in detail. Different forms of Sofpironium Bromide DMFs exist exist since differing nations have different regulations, such as Sofpironium Bromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Sofpironium Bromide DMF submitted to regulatory agencies in the US is known as a USDMF. Sofpironium Bromide USDMF includes data on Sofpironium Bromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sofpironium Bromide USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Sofpironium Bromide suppliers with USDMF on PharmaCompass.

Sofpironium Bromide NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Sofpironium Bromide as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Sofpironium Bromide API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Sofpironium Bromide as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Sofpironium Bromide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sofpironium Bromide NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Sofpironium Bromide suppliers with NDC on PharmaCompass.

Sofpironium Bromide GMP

Sofpironium Bromide Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Sofpironium Bromide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Sofpironium Bromide GMP manufacturer or Sofpironium Bromide GMP API supplier for your needs.

Sofpironium Bromide CoA

A Sofpironium Bromide CoA (Certificate of Analysis) is a formal document that attests to Sofpironium Bromide's compliance with Sofpironium Bromide specifications and serves as a tool for batch-level quality control.

Sofpironium Bromide CoA mostly includes findings from lab analyses of a specific batch. For each Sofpironium Bromide CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Sofpironium Bromide may be tested according to a variety of international standards, such as European Pharmacopoeia (Sofpironium Bromide EP), Sofpironium Bromide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sofpironium Bromide USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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