Fezolinetant is under clinical development by Astellas Pharma and currently in the Pre-Registration 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 Fezolinetant’s likelihood of approval (LoA) and phase transition for Vasomotor Symptoms of Menopause (Hot Flashes) took place on 22 Aug 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 Fezolinetant Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Fezolinetant overview

Fezolinetant (ESN-364) is under development for the treatment of menopause-related vasomotor symptoms. It is administered orally. The drug candidate acts by targeting NK3 receptor. It was also under development for the treatment of benign prostatic hyperplasia, polycystic ovarian syndrome, uterine fibroids and endometriosis.

Astellas Pharma overview

Astellas Pharma (Astellas) discovers, develops, manufactures, and commercializes a wide range of pharmaceuticals. The company’s product portfolio comprises marketed products for the treatment of a wide range of urological diseases, infectious diseases, cancer, nephrology, and metabolic diseases, immunodeficiency diseases, and transplantation. Its pipeline possesses drug candidates for the treatment of urothelial cancer; gastric cancer; gastroesophageal junction cancer; anemia associated with chronic kidney disease (CKD) in dialysis; Rheumatoid arthritis and non-dialysis patients; menopause-related vasomotor symptoms (MR-VMS) such as hot flashes and night sweats; and acute myeloid leukemia (AML), among others. It operates in the Americas, Australia, Europe, and Asia and Oceania through a network of subsidiaries and affiliates. Astellas is headquartered in Tokyo, Japan.

Quick View Fezolinetant LOA Data

Report Segments
  • Innovator
Drug Name
  • Fezolinetant
Administration Pathway
  • Oral
Therapeutic Areas
  • Male Health
  • Non Malignant Disorders
  • Women’s Health
Key Developers
Highest Development Stage
  • Pre-Registration

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.