DMPA SI
TV-46046
- User: Female
- Hormonal: Hormonal
-
Delivery type:
- Injectable
-
Intended Duration:
- Short-Acting
- Development Stage: Phase I
- Developer(s)/researcher(s): Teva, FHI 360
Details
- API: Medroxyprogesterone Acetate
- Target: Progesterone Receptor
-
Mechanism of Action:
- Ovulation Inhibition
- Cervical Mucus Changes
- Regimen: 1 Injection/6 Months
- MPT: Not Potential MPT
- Promising Attributes: A longer-acting injectable has the potential to improve compliance, continuation, and therefore, effectiveness. Self-injection may improve uptake and lower burden on health systems.
Product Status
Active Formulation, Delivery System Evaluation, and Clinical Development
History
2013: FHI 360 and Teva Pharmaceuticals initiate collaboration to develop a 6-month MPA-based self-injectable, TV-46046
2016: Phase I PK study initiated
2018: Phase I tolerability study initiated
2020: Phase I/2 dose range finding study initiated
2023-Present: FHI 360 becomes IND sponsor, now leads clinical development and regulatory strategy.