Buprenorphine is under clinical development by Chiesi Farmaceutici and currently in the 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 Buprenorphine’s likelihood of approval (LoA) and phase transition for Opium Withdrawal Syndrome took place on 06 Jun 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 Buprenorphine Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Buprenorphine overview

Buprenorphine is under development for the treatment of neonatal abstinence syndrome (NAS). The drug candidate is administered through sublingual route. It acts by targeting mu-opioid receptor and kappa receptor.

Chiesi Farmaceutici overview

Chiesi Farmaceutici (Chiesi) researches, develops, produces and commercializes novel medicines with a focus on respiratory, neonatology, rare disease and special care therapeutic areas. The company provides products for the treatment of chronic obstructive pulmonary disease (COPD), asthma, rheumatoid arthritis, ankylosing spondylitis, hypertension, percutaneous coronary intervention, apnoea of prematurity, respiratory distress syndrome, lipoprotein lipase deficiency (LPLD), limbal stem cell deficiency (LSCD) and inflammatory bowel diseases, among others. The company operates production sites in Parma, Italy; Blois, France; and Santana De Parnaiba, Brazil; and conducts research and development activities at its R&D center in Parma and at laboratories in Paris (France), Chippenham (the UK), Cary (the US) and Lidingo (Sweden). Chiesi is headquartered in Parma, Emilia-Romagna, Italy.

Quick View Buprenorphine LOA Data

Report Segments
  • Innovator
Drug Name
  • Buprenorphine
Administration Pathway
  • Sublingual
Therapeutic Areas
  • Central Nervous System
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.