Nov. 23, 2025 /Mpelembe Media/ — A market insights report on the Alcohol Use Disorder (AUD) treatment market conducted by a life sciences market research firm, forecasts that the AUD market will grow rapidly at a Compound Annual Growth Rate (CAGR) of 13.6% by 2034, driven by rising disease prevalence and advancements in innovative therapies, including genetically-targeted treatments. The AUD market size was estimated at USD 1.1 billion in 2024 across seven key markets, with the United States accounting for the majority of the revenue. The report discusses current treatments and several emerging therapies in the pipeline from companies like Adial Pharmaceuticals and Beckley Psytech, which are expected to reshape the treatment landscape despite an ongoing significant treatment gap in patient care.
The future of Alcohol Use Disorder (AUD) treatment is being shaped by advancements in several innovative and emerging therapies, including genetically-targeted approaches and novel treatments such as GLP-1 Receptor Agonists. These emerging treatments are expected to transform the AUD market landscape, offering new standards of care and growth opportunities.
Several key companies are developing promising candidates in the pipeline, many of which are targeting moderate-to-severe AUD.
Emerging Therapies and Developing Companies
The following companies and their emerging therapies are currently active in mid- and late-stage research and development for AUD:
| Company | Emerging Therapy | Drug/Mechanism Type | Current Development Status & Milestones |
|---|---|---|---|
| Adial Pharmaceuticals | AD04 (ondansetron) | Genetically-targeted therapy | Currently in a Phase III clinical trial. It targets specific genotypes identified via the company’s proprietary companion diagnostic genetic test. Adial intends to initiate the Phase III trial in the latter half of 2025, with a potential commercial launch anticipated by 2027. |
| Beckley Psytech and Atai Life Sciences | BPL-003 (intranasal 5-MeO-DMT benzoate/mebufotenin benzoate) | Intranasal 5-MeO-DMT benzoate formulation | Designed to produce rapid and lasting effects from a single dose. A recent open-label Phase IIa trial in patients with moderate-to-severe AUD was completed. In January 2025, positive top-line results showed significant and sustained reductions in alcohol consumption and heavy drinking days (HDDs) for up to three months after a single dose. |
| Imbrium Therapeutics (subsidiary of Purdue Pharma) | Sunobinop (V117957) | Emerging therapy | Results from the Phase II trial for treating moderate-to-severe AUD are expected in 2026, with a potential US launch projected for 2030. |
| Altimmune | Pemvidutide | GLP-1 Receptor Agonist | Altimmune enrolled the first subject in the RECLAIM Phase II trial evaluating the efficacy and safety of pemvidutide in subjects with AUD in May 2025. |
| Tempero Bio and Nxera Pharma | TMP-301/HTL0014242 | Emerging therapy | Tempero Bio closed a USD 70 million Series B financing in March 2025. The proceeds will be used to advance TMP-301 through two Phase II clinical trials for AUD and cocaine use disorder, as well as Phase III-enabling activities. |
| MediciNova | Ibudilast (MN-166) | Emerging therapy | A June 2025 news release reported that a UCLA clinical trial found ibudilast did not significantly reduce overall alcohol consumption compared to placebo, but it did demonstrate a positive effect among female participants. |
Impact of Emerging Treatments
The rise of these therapies is notable because current AUD treatments often face limitations, including unmet clinical needs and limited efficacy. The development focus is shifting toward personalized care, harm reduction strategies, and combination approaches (behavioral plus pharmacological). Emerging treatments like AD04, which is a genetically-targeted therapy, exemplify the shift towards treating AUD based on individual risk profiles, as there are currently no approved treatments specifically tailored to AUD severity.
The anticipated launch of these cutting-edge therapies is expected to reshape the AUD market landscape in the coming years. The AUD market is forecasted to grow rapidly at a 13.6% CAGR by 2034, driven partially by these advancements.
These emerging therapies act like keys designed for specific locks, moving away from a single master key approach for all AUD patients, and aiming to unlock more effective and personalized treatment outcomes.
To understand the etiology of alcohol use disorder, Continue reading