Linzagolix choline is under clinical development by Kissei Pharmaceutical and currently in the 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 Linzagolix choline’s likelihood of approval (LoA) and phase transition for Endometriosis took place on 29 Sep 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 Linzagolix choline Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Linzagolix choline overview

Linzagolix (Yselty) is a small-molecule, non-peptide, orally active gonadotropin-releasing hormone antagonist. It is formulated as film coated tablets for oral route of administration. Yselty is indicated for the management of moderate to severe symptoms of uterine fibroids (UF) in adult women (over 18 years of age) of reproductive age.

Linzagolix choline is under development for the treatment of endometriosis associated pain and uterine fibroids. It is a new chemical entity (NCE). The drug candidate is administered orally as a film coated tablet. KLH-2109 targets gonadotrophin-releasing hormone (GnRH).

Kissei Pharmaceutical overview

Kissei Pharmaceutical (Kissei) discovers, develops, manufactures, and sells a range of innovative pharmaceutical products. The company’s pharmaceutical products include urological medicine, metabolic endocrinology medicine, drugs for kidney and dialysis department, drugs for obstetrics and gynecology, ophthalmic medicine and rare disease medicine. It also develops and sells health foods including protein-controlled food, energy supply food, calorie-controlled food, and elderly controlled food. Kissei conducts research to develop novel drugs and improve existing drugs and provide superior drugs to people worldwide. The company has sales offices across Japan and an overseas subsidiary in New Jersey, the US. Kissei is headquartered in Matsumoto, Japan.

Quick View Linzagolix choline LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Linzagolix choline
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Non Malignant Disorders
  • 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.