Hydroxyprogesterone caproate is under clinical development by Lipocine and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Hydroxyprogesterone caproate’s likelihood of approval (LoA) and phase transition for Premature Labor (Tocolysis) took place on 20 Jul 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Hydroxyprogesterone caproate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Hydroxyprogesterone caproate overview

Hydroxyprogesterone caproate (LPCN-1107) is under development for the prevention of preterm birth. LPCN-1107 is human progestogen and acts by targeting  progesterone receptor. The drug candidate is administered through oral route. It is based on Lip'ral technology.

Lipocine overview

Lipocine operates as a pharmaceutical company that develops and commercializes treatments for men’s and women’s health. The company’s pipeline products for men’s health include LPCN 1111 and LPCN 1021, and for women’s health include LPCN 1107. It’s LPCN 1111 is an oral testosterone product candidate and LPCN 1021 is an oral testosterone replacement therapy with a positive topline. Lipocine offers LPCN 1107, an oral hydroxyprogesterone caproate product for the prevention of preterm birth. It develops patented technology based on lipidic compositions that form an optimal dispersed phase in the gastrointestinal environment for improved absorption of the insoluble drug. Its Lip’ral is a technology based on lipidic compositions that form optimal dispersed phases in the gastrointestinal environment. Lipocine is headquartered in Salt Lake City, Utah, US

Quick View Hydroxyprogesterone caproate LOA Data

Report Segments
  • Innovator
Drug Name
  • Hydroxyprogesterone caproate
Administration Pathway
  • Oral
Therapeutic Areas
  • Women’s Health
Key Developers
Highest Development Stage
  • Phase II

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.