Taiwanese drugmaker Alar Pharmaceuticals plans to evaluate multiple dosing regimens of its opioid addiction treatment INDV-6001 in pre-Phase III trials across the United States, marking a key step in the development of a potential long-acting alternative to current therapies.
The study will enroll 122 patients with moderate to severe opioid addiction across six test groups, exploring various dosing intervals ranging from monthly to quarterly administration. The trial will assess both treatment-naive patients and those currently using Indivior’s Sublocade injection.
The development follows Alar’s NT$27.5 billion (US$862 million) licensing deal with UK-based Indivior last March, which also includes royalties of 10% to 15% on future sales.
Patients will receive injections of varying strengths, from 100mg to 600mg, with some groups transitioning from Suboxone tablets or Sublocade injections. The study will examine different injection sites and track pharmacokinetic parameters through October 2025.
If successful, Alar Pharmaceuticals expects to advance INDV-6001 into Phase III trials in early 2026. The company aims to establish the drug’s safety profile and optimal dosing schedule before proceeding with late-stage development.
