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Details:
FP-001 (leuprolide mesylate), which is a Gonadotropin-releasing hormone receptor agonist. Currently, it is being evaluated in Phase III clinical trial studies with patients related to Central Precocious Puberty.
Lead Product(s): Leuprolide Mesylate
Therapeutic Area: Endocrinology Product Name: FP-001
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2024
Details:
FP-001 (leuprolide), a gonadotropin-releasing hormone (GnRH) agonist, is being developed for for the treatment of Central Precocious Puberty patients.
Lead Product(s): Leuprolide Mesylate
Therapeutic Area: Endocrinology Product Name: FP-001
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2023
Details:
The proceeds will be used to develop Camcevi, a leuprolide mesylate injection, in a Phase 3 trial for central precocious puberty, FP-045, an ALDH2 activator, in a Phase 1b/2 trial for Fanconi Anemia, and FP-025, an MMP-12 inhibitor, in a Phase 2 study for respiratory disease.
Lead Product(s): Leuprolide Mesylate
Therapeutic Area: Endocrinology Product Name: Camcevi
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $42.3 million Upfront Cash: Undisclosed
Deal Type: Financing June 27, 2023
Details:
CAMCEVI is the first-ever ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection that comes in a pre-filled syringe with no mixing required. In an open-label, single-arm study of 137 adults who received 42mg of CAMCEVI on Day 0 and Week 24.
Lead Product(s): Leuprolide Mesylate
Therapeutic Area: Oncology Product Name: Camcevi
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2022
Details:
GenScience Pharmaceuticals will get license for the commercialization of Foresee’s novel FP-001 program, Leuprolide Mesylate Injectable Suspension (LMIS) ready-to-use subcutaneous 6-month and 3-month depot formulations. The license agreement will cover the China market.
Lead Product(s): Leuprolide Mesylate
Therapeutic Area: Oncology Product Name: Camcevi
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: GenScience Pharmaceuticals
Deal Size: $124.0 million Upfront Cash: $8.0 million
Deal Type: Licensing Agreement November 17, 2020
Details:
FDA, in its Day-74 letter, stated that the New Drug Application (NDA) for CAMCEVI 42MG is sufficiently complete to permit a substantive review.
Lead Product(s): Leuprolide Mesylate
Therapeutic Area: Oncology Product Name: Camcevi
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 09, 2020
Details:
This NDA submission is supported by a previously communicated successful Phase 3 study in 137 Advanced Prostate Carcinoma patients, where treatment with LMIS 50 mg injection every 6 months was demonstrated to be effective, safe and well tolerated.
Lead Product(s): Leuprolide Mesylate
Therapeutic Area: Oncology Product Name: Camcevi
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2020
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