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Details:
SOLOSEC (secnidazole) 2 g oral granules is the first, single-dose oral approved to treat both bacterial vaginosis, common vaginal infection, in female patients 12 years of age and older and trichomoniasis, sexually transmitted infection, in patients 12 years of age and older.
Lead Product(s): Secnidazole
Therapeutic Area: Infections and Infectious Diseases Product Name: Solosec
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 17, 2022
Details:
This partnership will expand the reach of SOLOSEC®, allowing more Healthcare Providers to be aware of the benefits of SOLOSEC®, and increase access for adult women suffering with bacterial vaginosis and adults with trichomoniasis.
Lead Product(s): Secnidazole
Therapeutic Area: Infections and Infectious Diseases Product Name: Solosec
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Lupin Ltd
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 27, 2022
Details:
Solosec is used for treatment of vaginal infection among women of childbearing age — became Lupin’s asset after it acquired Symbiomix Therapeutics.
Lead Product(s): Secnidazole
Therapeutic Area: Infections and Infectious Diseases Product Name: Solosec
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2021
Details:
The Solosec® sNDA is based, in part, on trial results that showed a clinically and statistically significant response rate, or microbiological cure, in patients treated with Solosec® as compared to placebo.
Lead Product(s): Secnidazole
Therapeutic Area: Infections and Infectious Diseases Product Name: Solosec
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2020
Details:
Single-dose treatment with Solosec® resulted in a highly statistically significant response rate, or microbiological cure, in 92-95% of patients versus 1.5-1.7% in placebo.
Lead Product(s): Secnidazole
Therapeutic Area: Infections and Infectious Diseases Product Name: Solosec
Highest Development Status: 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
Details:
The promotional arrangement includes detailing and demonstration of Ceek's products, alongside Lupin's women's health flagship product, Solosec 2g oral granules, indicated for the treatment of bacterial vaginosis. Solosec is a 5-nitroimidazole antimicrobial agent.
Lead Product(s): Secnidazole
Therapeutic Area: Infections and Infectious Diseases Product Name: Solosec
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Lupin Ltd
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 09, 2020
Details:
Phase 3 Study of Single-Dose Solosec® demonstrated a clinically and statistically significant response rate, or microbiological cure, in patients dosed with Solosec® as compared to placebo.
Lead Product(s): Secnidazole
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 04, 2020
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