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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
| Molecular Weight | 470.4 g/mol |
|---|---|
| Molecular Formula | C22H32BrNO5 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 9 |
| Exact Mass | 469.14639 g/mol |
| Monoisotopic Mass | 469.14639 g/mol |
| Topological Polar Surface Area | 72.8 Ų |
| Heavy Atom Count | 29 |
| Formal Charge | 0 |
| Complexity | 555 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31310
Submission : 2017-09-22
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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...
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 ...

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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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Lead Product(s) : Sofpironium Bromide,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
No sweat for dermatology specialist Botanix as hyperhidrosis gel Sofdra gains FDA approval
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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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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Lead Product(s) : Sofpironium Bromide,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Botanix Pharma
Deal Size : $8.2 million
Deal Type : Agreement
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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Lead Product(s) : Sofpironium Bromide,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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
Brickell Biotech Closing of $8.05 Million Bought Deal Offering , Including Full Exercise
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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Lead Product(s) : Sofpironium Bromide,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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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Lead Product(s) : Sofpironium Bromide,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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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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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Lead Product(s) : Sofpironium Bromide,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Brickell Biotech Doses First Patient in Second U.S. Pivotal Phase 3 Clinical Study
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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Lead Product(s) : Sofpironium Bromide,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Brickell Biotech Announces Initiation of U.S. Phase 3 Program Evaluating Sofpironium Bromide Gel
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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Lead Product(s) : Sofpironium Bromide,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Fresh Tracks Therapeutics
Deal Size : Inapplicable
Deal Type : Inapplicable
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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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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Lead Product(s) : Sofpironium Bromide,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Kaken Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
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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Regulatory Info : RX
Registration Country : USA
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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]https://www.pharmacompass.com/radio-compass-blog/fda-okays-50-new-drugs-in-2024-bms-cobenfy-lilly-s-kisunla-lead-pack-of-breakthrough-therapies

21 Jun 2024
// Zoey Becker FIERCE PHARMA
https://www.fiercepharma.com/pharma/no-sweat-dermatology-drugmaker-botanix-fda-approval-hyperhidrosis-gel-sofdra

04 May 2022
// TROUTMAN
https://www.troutman.com/insights/troutman-pepper-advises-clinical-dermatology-company-botanix-pharmaceuticals-in-acquisition-of-sofpironium-bromide.html

16 Aug 2021
// GLOBENEWSWIRE
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

29 Jun 2021
// GLOBENEWSWIRE
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

18 Nov 2020
// GLOBENEWSWIRE
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

25 Sep 2020
// Vandana Singh SEEKING ALPHA
https://seekingalpha.com/pr/18020127-brickell-biotech-announces-approval-of-sofpironium-bromide-gel-5-in-japan-for-treatment-of
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Patents & EXCLUSIVITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Sofpironium Bromide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Sofpironium Bromide manufacturer or Sofpironium Bromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sofpironium Bromide manufacturer or Sofpironium Bromide supplier.
PharmaCompass also assists you with knowing the Sofpironium Bromide API Price utilized in the formulation of products. Sofpironium Bromide API Price is not always fixed or binding as the Sofpironium Bromide Price is obtained through a variety of data sources. The Sofpironium Bromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
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.
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.
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).
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.
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.
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 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.
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).