Alcohol‑use disorder pipeline expands in 2026
A new industry report profiles over 30 companies and 30+ therapies advancing treatments for Alcohol Use Disorder this year, spanning digital therapeutics, novel drugs, and integrated behavioral models. The pipeline suggests a more diversified approach to addiction care is gaining commercial momentum. (openpr.com)
DelveInsight released “Alcohol Use Disorder (AUD) – Pipeline Insight, 2026,” an 80‑page clinical and commercial assessment of the AUD development landscape published in 2026. (delveinsight.com) Press coverage of the report cites rostered developers that include Pear Therapeutics, Cybin, BioXcel Therapeutics, Dicerna Pharmaceuticals, Astellas, MediciNova, Adial Pharmaceuticals, Addex Therapeutics, Alkermes and Teva. (abnewswire.com) Adial Pharmaceuticals completed a pharmacokinetics study of its genetically‑targeted ondansetron candidate AD04 and submitted those results to the FDA in 2025. (adial.com) Regulatory briefing documents show the FDA provided favourable end‑of‑Phase‑2 feedback on AD04’s Phase‑3 design to target heavy drinkers with specific 5‑HT3 genotypes. (psychiatrictimes.com) Imbrium Therapeutics, a Purdue Pharma subsidiary, randomized and dosed the first patient in a Phase‑2 trial of sunobinop for moderate to severe AUD on November 18, 2024. (businesswire.com) The sponsor describes sunobinop as an oral nociceptin/orphanin‑FQ peptide receptor (NOP) agonist under investigation for substance‑use indications. (imbriumthera.com) Addex Therapeutics’ research collaboration with Indivior has produced GABAB positive‑allosteric modulator (PAM) clinical candidates aimed at substance‑use disorders, per company disclosures. (addexpharma.com) Separately, Addex announced it regained rights to the Phase‑2 mGlu2 PAM asset ADX71149 as part of its small‑molecule neurology portfolio. (addextherapeutics.com) Pear Therapeutics’ prescription digital therapeutic reSET‑A holds prior FDA Breakthrough Device designation for AUD (designation announced November 22, 2021) and Pear has presented real‑world engagement and abstinence data for reSET platforms at clinical meetings. (neuro-central.com) (marketscreener.com) Market analyses cited in the report place AUD market value in leading markets at roughly USD 1.1 billion in 2024 and project a compound annual growth rate near 13.6% through 2034. (prnewswire.com) Multiple controlled and single‑site trials continue to investigate psychedelic approaches for AUD, including a phase‑2 psilocybin trial for veterans and first responders registered as NCT06853912 and a planned large single‑site trial at the University of Calgary, while a 2025 Lancet eClinicalMedicine protocol discussed single‑dose psilocybin relapse‑prevention studies. (ichgcp.net) (cumming.ucalgary.ca) (thelancet.com)
