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Solifenacin","therapeuticArea":"Urology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Approved"},{"orgOrder":0,"company":"MSN Laboratories","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MSN Laboratories Gets CDSCO Panel Nod For FDCs Solifenacin, Mirabegron Capsules","therapeuticArea":"Urology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Approved"},{"orgOrder":0,"company":"Camber Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Camber Pharmaceuticals Launches Generic Vesicare\u00ae","therapeuticArea":"Urology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Approved"},{"orgOrder":0,"company":"Adalvo","sponsor":"Adamed Pharma","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Adalvo and Adamed Pharma Team up to Launch Solifenacin + Tamsulosin in Europe","therapeuticArea":"Urology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Approved"},{"orgOrder":0,"company":"Sawai Pharmaceutical Co., Ltd.","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sawai Receives Approvals for Eight Generic Drugs with 20 Strengths","therapeuticArea":"Urology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Approved"},{"orgOrder":0,"company":"Sumitomo","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sumitomo Pharma Announces Positive Topline Results from Phase 3 Clinical Studies Evaluating Vibegron in Men with Overactive Bladder Symptoms Receiving Pharmacological Therapy for Benign Prostatic Hyperplasia","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase III"},{"orgOrder":0,"company":"Glycologix","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Glycologix Treats First Patient in Pilot Study of GLX-100 for Treatment of Interstitial Cystitis\/Bladder Pain Syndrome","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Phase I"},{"orgOrder":0,"company":"Onconetix","sponsor":"Blue Water Vaccines","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Blue Water Biotech Acquires Proteomedix as Part of Transformation to Commercial Stage Oncology Company; Announces Name Change to Onconetix","therapeuticArea":"Urology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Approved"},{"orgOrder":0,"company":"EG 427","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"EG427 Announces New Preclinical Results from Multiple Studies of EG110A in Neurogenic Detrusor Overactivity (NDO) and Overactive Bladder (OAB)","therapeuticArea":"Urology","highestDevelopmentStatus":"IND Enabling","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"IND Enabling"},{"orgOrder":0,"company":"Sun Pharmaceutical Industries Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"SUN Pharma Gets CDSCO Nod to Manufacture, Market FDC Silodosin JP Plus Tadalafil","therapeuticArea":"Urology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Approved"},{"orgOrder":0,"company":"Dongkook Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Will Dongkook Pharm Present New Combo Therapy for BPH?","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase III"}]

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            Details:

            Fesoterodine Fumarate Extended-Release Tablets, a therapeutic generic equivalent to Toviaz® (fesoterodine fumarate) Extended-Release Tablets, a muscarinic antagonist indicated for the treatment of overactive bladder.

            Lead Product(s): Fesoterodine

            Therapeutic Area: Urology Product Name: Fesoterodine Fumarate-Generic

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 08, 2022

            Details:

            Finasteride and tadalafil combination is used to treat men with benign prostatic hyperplasia (BPH). Tadalafil is a PDE5 inhibitor and finasteride blocks the action of 5-alpha-reductase which will increase testosterone levels in the body, which decreases prostate size.

            Lead Product(s): Finasteride,Tadalafil

            Therapeutic Area: Urology Product Name: Finasteride/Tadalafil-Generic

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 26, 2021

            Prague Scientific Banner

            TMF Summit 2024

            Not Confirmed

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            Details:

            The FDA approval is based on data from a randomized, double-blind Phase 3 study evaluating the safety and efficacy of BOTOX® in more than 100 pediatric patients with neurogenic detrusor overactivity and a long-term extension study.

            Lead Product(s): OnabotulinumtoxinA

            Therapeutic Area: Urology Product Name: Botox

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 10, 2021

            Abbvie Company Banner

            TMF Summit 2024

            Not Confirmed

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            Strides Pharma Global has received approval for Oxybutynin Chloride Tablets USP, 5 mg from the USFDA. Oxybutynin Chloride is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Ditropan Tablets, 5 mg, of Janssen Pharmaceuticals, Inc.

            Lead Product(s): Oxybutynin Hydrochloride

            Therapeutic Area: Urology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 18, 2020

            Strides Pharma Science

            TMF Summit 2024

            Not Confirmed

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            Details:

            EG110A is based on company's unique non-replicative HSV-1 vector platform. It is being evaluated in preclinical studies for the treatment of neurogenic detrusor overactivity (NDO) and overactive bladder (OAB).

            Lead Product(s): EG110A

            Therapeutic Area: Urology Product Name: EG110A

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 04, 2024

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            Details:

            The combined company will focus on the R&D and commercialization of proprietary science and technologies for therapeutics, including Entadfi, a once-daily, oral treatment for BPH that combines finasteride, a 5α-reductase inhibitor, and tadalafil, a PDE5 inhibitor.

            Lead Product(s): Finasteride,Tadalafil

            Therapeutic Area: Urology Product Name: Entadfi

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Blue Water Vaccines

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition December 18, 2023

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            CDSCO has approved Silodosin (selective alpha1A-adrenergic receptor antagonist) + Tadalafil (PDE5 inhibitor), a fixed dose combination for the treatment of benign prostatic hyperplasia.

            Lead Product(s): Silodosin,Tadalafil

            Therapeutic Area: Urology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 07, 2023

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            GLX-100 is a novel biopolymer, which has been designed to closely replicate the natural protective barrier layer and relieve the symptoms of Interstitial Cystitis/Bladder Pain Syndrome and Phase I results anticipated in 2024.

            Lead Product(s): GLX-100

            Therapeutic Area: Urology Product Name: GLX-100

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 24, 2023

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            DKF-313 is a combination of dutasteride (5α-reductase inhibitor) and tadalafil (PDE5 inhibitor). It is being evaluated in phase 3 clinical trials for the treatment of benign prostatic hyperplasia.

            Lead Product(s): Dutasteride,Tadalafil

            Therapeutic Area: Urology Product Name: DKF-313

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 26, 2023

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            Gemtesa (vibegron) is a once-daily beta-3 adrenergic receptor (β3) agonist, is currently under investigation for the treatment of men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia.

            Lead Product(s): Vibegron

            Therapeutic Area: Urology Product Name: Gemtesa

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 11, 2023

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