Nalbuphine hydrochloride ER is under clinical development by Trevi Therapeutics and currently in Phase III for Pruritus. According to GlobalData, Phase III drugs for Pruritus have a 64% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Nalbuphine hydrochloride ER’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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. 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 and uremic pruritus.

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.

For a complete picture of Nalbuphine hydrochloride ER’s drug-specific PTSR and LoA scores, buy the report here.


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.