Tianeptine is under clinical development by AMO Pharma and currently in the Phase I and 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 Tianeptine’s likelihood of approval (LoA) and phase transition for Respiratory Depression (Hypoventilation) took place on 03 May 2021, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.

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

Tianeptine overview

Tianeptine (AMO-04/REV-001) is under development for the treatment of Rett syndrome and opioid-induced respiratory depression. It is administered orally and intravenous route. Tianeptine (AMO-04/REV-001) acts by targeting the glutamate receptor. The drug candidate is a thiazepine derivative. It was under development for the treatment of post-operative opioid (morphine) induced respiratory depression in patients with sleep apnea

AMO Pharma overview

AMO Pharma is a biopharmaceutical company that develops novel treatments for serious and debilitating diseases. The company offers pipeline product portfolio such as AMO-01, and AMO-02. Its AMO-01 is being developed for the treatment of autism and intellectual disabilities. It is an inhibitor of the ras-extracellular signal-regulated kinase pathway (Ras-ERK). AMO Pharma offers AMO-02 which is used for the treatment of myotonic dystrophy, CNS, neuromuscular and oncology indications, among others. It is an inhibitor of glycogen synthase kinase 3 beta. The company provides target therapy areas such as central nervous system disorders, neuromuscular, and Steinert’s disease. It also has operations in the US and the UK. AMO Pharma is headquartered in London, the UK.

Quick View Tianeptine LOA Data

Report Segments
  • Innovator
Drug Name
  • Tianeptine
Administration Pathway
  • Intravenous
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Respiratory
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.