Following a management restructuring, Indivior, the licensing partner of Alar Pharmaceuticals, has further concentrated its resources on addiction treatment drugs. The licensed compound NDV-60001 (ALA-1000) is currently undergoing a multiple-dose pharmacokinetic study across ten active clinical sites and is expected to officially enter Phase III clinical trials in the first quarter of next year. Meanwhile, ALA-3000, a treatment developed in-house by Alar for treatment-resistant depression, has also enrolled its first subject in a Phase I trial in the United States.
In October 2023, Alar Pharmaceuticals licensed out three formulations of its long-acting opioid addiction injection ALA-1000 (1-month, 3-month, and 6-month versions) to Indivior for a total deal value of USD 862 million. Indivior has since initiated a multiple-dose pharmacokinetic clinical trial. According to its public disclosures, patient enrollment is ongoing at 10 of the 11 planned clinical sites.
Following its leadership reorganization, Indivior’s new CEO reiterated a sharpened focus on addiction medicine and confirmed plans to launch Phase III clinical trials in the first quarter of 2026. The company also reaffirmed its target of reaching USD 1 billion in sales this year for its existing addiction treatment product, Sublocade.
Industry insiders interpret Indivior’s strategic moves as a response to mounting competition, which necessitates the expansion of its product offerings with varying dosing intervals and formulations. The anticipated Phase III trial may involve both multiple dosing schedules and durations in parallel, which would benefit Alar through milestone payments tied to each formulation. Strong downstream sales performance could also boost long-term revenue sharing for Alar.
As for ALA-3000, intended for treatment-resistant depression, Alar received FDA approval in December last year to initiate a combined Phase I/II clinical trial. The first stage will enroll 40 subjects for safety assessment, and the first participant was officially enrolled in the U.S. on May 14 this year.
Resource: 昱展ALA-1000拚明年啟三期：授權夥伴可望更聚焦
