LACTIN-V is under clinical development by Osel and currently in the Phase I, Phase II and Phase III 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 LACTIN-V’s likelihood of approval (LoA) and phase transition for Bacterial Vaginosis took place on 31 Aug 2021, 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 LACTIN-V Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

LACTIN-V overview

LACTIN-V is under development for the prevention and treatment of recurrent bacterial vaginosis, preterm birth and recurrent urinary tract infections (rUTI). The therapeutic candidate is administered through vaginal route. The therapeutic candidate contains a single strain of Lactobacillus crispatus, CTV-05 and may aid in the treatment of infections. It was also under development for the treatment of Candida infection (yeast infections).

Osel overview

Osel develops live bio therapeutic products. The company’s clinical pipeline offers clinical stage and preclinical platform products. Its preclinical platform includes MucoCept technology platform for prevention of HIV infection. Osel’s LACTIN-V is a biotherapeutic product for women’s health disorders and patients with bacterial vaginosis and recurrent urinary tract infections. The company’s products are used in the therapeutic areas of women’s health and gastrointestinal tract disorders including recurrent urinary tract infections, recurrent bacterial vaginosis, inflammatory bowel diseases, and antibiotic-associated diarrhea, among others. It provides clinical trial services for validations of new therapeutic products. Osel is headquartered in Mountain View, California, the US.

Quick View LACTIN-V LOA Data

Report Segments
  • Innovator
Drug Name
Administration Pathway
  • Vaginal
Therapeutic Areas
  • Genito Urinary System And Sex Hormones
  • Infectious Disease
  • Women’s Health
Key Developers
  • Sponsor Company: Osel
  • Originator: GyneLogix
Highest Development Stage
  • Phase III


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.