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KSHG004
- Development stage
- Unknown
- Lead developer
- Kashiv BioSciences
- Modality
- Peptides
- Administration
- Subcutaneous
01
Overview
KSHG004 is a generic peptide drug candidate being developed by Kashiv BioSciences (formerly Kasway Biotech) for the treatment of fertility-related conditions. As a generic peptide, it is designed to be bioequivalent to an existing reference listed drug (RLD) used in reproductive medicine, such as a gonadotropin-releasing hormone (GnRH) agonist or antagonist. The program is part of Kashiv's complex generics pipeline, which focuses on difficult-to-characterize and manufacture injectable products. KSHG004 is currently in early-phase clinical development (Phase 1), typically following the 505(j) or 505(b)(2) regulatory pathways for approval in the United States.
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