(Citric acid + lactic acid + potassium bitartrate) is under clinical development by Evofem Biosciences and currently in the Phase I 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 (Citric acid + lactic acid + potassium bitartrate)’s likelihood of approval (LoA) and phase transition for Bacterial Vaginosis took place on 14 Oct 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their (Citric acid + lactic acid + potassium bitartrate) Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

(Citric acid + lactic acid + potassium bitartrate) overview

Citric acid, Lactic acid and Potassium bitartrate (Phexxi) is a fixed dose combination act as non-hormonal contraception. It is formulated as gel for vaginal route of administration. Phexxi is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. Phexxi is not effective for the prevention of pregnancy when administered after intercourse.

Amphora is under development as a female contraception, prevention of bacterial vaginosis. The therapeutic candidate is administered through vaginal route. It is a non-hormonal vaginal contraceptive gel that consists of L-lactic Acid, citric acid, and potassium bitartrate. It was also under development for genital herpes, chlamydia trachomatis infection, Neisseria gonorrhoeae infections  and HIV-1 infections.

Evofem Biosciences overview

Evofem Biosciences (Evofem) carries out the development and commercialization of reproductive and contraceptive care products for women. The company’s pipeline products include phexxi, a hormone-free contraceptive vaginal gel; and EVO200 vaginal gel, to treat recurrent bacterial vaginosis (BV). It uses proprietary multipurpose prevention technology (MPT) vaginal gel candidate for multiple indications which include human immunodeficiency virus (HIV) prevention; contraception; prevention of urogenital transmission of chlamydia trachomatis infection and Neisseria gonorrhea infection in women. Evofem sells its product under the brand name Phexxi. The company markets its product across the globe through partnerships and licensing agreements. Evofem is headquartered in San Diego, California, US.

Quick View (Citric acid + lactic acid + potassium bitartrate) LOA Data

Report Segments
  • Innovator (Non-NME)
Drug Name
  • (Citric acid + lactic acid + potassium bitartrate)
Administration Pathway
  • Vaginal
Therapeutic Areas
  • Infectious Disease
  • Women’s Health
Key Developers
Highest Development Stage
  • Marketed

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.