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Find Drugs in Development News & Deals for Diclofenac Sodium

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  • TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION;TOPICAL - 2%
  • TABLET, DELAYED RELEASE;ORAL - 50MG;0.2MG
  • TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG
  • SOLUTION;TOPICAL - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • GEL;TOPICAL - 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • GEL;TOPICAL - 1%
  • SOLUTION;INTRAVENOUS - 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Details:

The launch of Dr. Reddy’s Diclofenac Sodium Topical Gel, 1% (OTC), is an important addition to the Pain/ Analgesics portfolio of OTC products, and represents the continued commitment to the Private Label OTC space.


Lead Product(s): Diclofenac Sodium

Therapeutic Area: Rheumatology Product Name: Diclofenac Sodium-Generic

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 09, 2020

Details:

DARE-PDM1 is a novel delivery of the diclofenac sodium, a NSAID drug which inhibits COX-1 and COX-2 responsible for producing PGs which contributes in inflammation and pain signalling. It uses Daré’s proprietary hydrogel technology targeted at treating primary dysmenorrhea.


Lead Product(s): Diclofenac Sodium

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: DARE-PDM1

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 22, 2023

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Details:

Because there are currently no FDA-approved vaginal diclofenac treatment options for primary dysmenorrhea, DARE-PDM1 has the potential to be a first-in-category product.


Lead Product(s): Diclofenac Sodium

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: DARE-PDM1

Highest Development Status: PreclinicalProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 12, 2022

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Details:

Diclofenac topical solution is used to treat pain and swelling caused by osteoarthritis of the knees. Diclofenac Sodium Topical Solution, 2% w/w (RLD PENNSAID®) had estimated annual sales of USD 509 million in the U.S.


Lead Product(s): Diclofenac Sodium

Therapeutic Area: Musculoskeletal Product Name: Diclofenac Sodium-Generic

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 09, 2022

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Details:

This phase 2/3 multi-center, randomized, double-blind trial investigated the effect of a new 3.06% diclofenac sodium gel formulation (AMZ001) for the relief of knee OA pain, in 444 patients exposed to either AMZ001 once daily (QD), AMZ001 twice daily (BID) or placebo.


Lead Product(s): Diclofenac Sodium

Therapeutic Area: Musculoskeletal Product Name: AMZ001

Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 14, 2020

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