Nalbuphine hydrochloride ER is under clinical development by Trevi Therapeutics and currently in the Phase I and 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 Nalbuphine hydrochloride ER’s likelihood of approval (LoA) and phase transition for Uremic (Renal) Pruritus took place on 26 Aug 2021, 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 Nalbuphine hydrochloride ER Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Nalbuphine hydrochloride ER overview

Nalbuphine hydrochloride ER (T-111) is under development for the treatment of chronic pruritus in prurigo nodularis, pruritis in chronic liver disease, chronic cough in idiopathic pulmonary fibrosis patients and levodopa-induced dyskinesia (LID) in Patients with Parkinson’s Disease, uremic pruritus. The drug candidate is administered through oral route as a tablet. The drug candidate is an extended release formulation of an existing compound nalbuphine hydrochloride. Nalbuphine is a phenanthrene derivative which targets opioid kappa and mu receptors and it was also under development for the treatment of atopic dermatitis. It was also under development for atopic dermatitis.

Trevi Therapeutics overview

Trevi Therapeutics, Inc. (Trevi Therapeutics), is a clinical-stage biopharmaceutical company that develops nalbuphine ER to treat neurologically mediated conditions by targeting central and peripheral nervous systems. It offers product Haduvio™ which uses for the treatment of serious cough conditions including IPF, interstitial lung diseases, and refractory chronic cough. The company offers nalbuphine ER as its pipeline product. Its product is being developed for treating patients with prurigo nodularis, pruritus in chronic liver disease, chronic cough related to idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID). It operates across the US. Trevi Therapeutics is headquartered in New Haven, Connecticut, the US.

Quick View Nalbuphine hydrochloride ER LOA Data

Report Segments
  • Innovator
Drug Name
  • Nalbuphine hydrochloride ER
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Dermatology
  • Gastrointestinal
  • Respiratory
Key Developers
Highest Development Stage
  • Phase III

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.