ACADIA Pharmaceuticals
ACADIA Pharmaceuticals, Inc. engages in the development and commercialization of medicines for central nervous system disorders. Its products include Nuplazid, which is used for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. The company was founded by Mark R. Brann on July 16, 1993 and is headquartered in San Diego, CA.
Clinical Trials
127
81 active
Approvals
5
Total approvals
Agencies
2
Regulatory bodies
Founded
1993
Active, not recruiting
79
62.2%
Approved For Marketing
1
0.8%
Completed
27
21.3%
Enrolling By Invitation
1
0.8%
Not yet recruiting
1
0.8%
Recruiting
10
7.9%
Terminated
8
6.3%
- Acadia Pharmaceuticals reported that once-daily 60 mg remlifanserin produced a 12.6-point reduction on the SAPS-H+D scale versus 10.4 points for placebo at week 6, an effect size of 0.26 (p=0.0603). - The key secondary endpoint of Clinical Global Impression-Severity showed a 1.3-point improvement with 60 mg remlifanserin versus 0.9 points for placebo, an effect size of 0.37 (nominal p=0.0077). - Remlifanserin showed adverse event, serious adverse event and discontinuation rates similar to placebo, with no QT prolongation signal, no deaths and no apparent negative impact on motor symptoms or cognition. - Acadia will continue enrolling two ongoing Phase 3 studies in Alzheimer's disease psychosis and will amend the program to remove the 30 mg dose arm, which showed minimal improvement over placebo.
- Acadia Pharmaceuticals will participate in a fireside chat at the Canaccord Genuity 46th Annual Growth Conference on August 12, 2026, at 1:30 p.m. Eastern Time. - The company markets the first and only FDA-approved treatments for Parkinson's disease psychosis and Rett syndrome, addressing significant unmet needs in neurological and rare diseases. - Acadia's pipeline includes mid- to late-stage programs targeting Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs for underserved patient populations. - A live webcast will be accessible via the company's investor relations website, with an archived recording available for approximately one month.
- The FDA has granted Fast Track designation to remlifanserin, Acadia's investigational 5-HT2A receptor inverse agonist, for treating hallucinations and delusions associated with Alzheimer's disease psychosis. - Alzheimer's disease psychosis currently has no FDA-approved therapies, highlighting a significant unmet medical need for the affected patient population. - Enrollment in the Phase 2 portion of the RADIANT development program has been completed, with topline results now expected between September and October 2026. - Screening and enrollment are already underway for the Phase 3 studies, consistent with the program's operationally seamless trial design.
- The global tardive dyskinesia market across the 7MM was valued at USD 4.4 billion in 2025, with the United States accounting for approximately 98% of the total market share. - Currently approved VMAT2 inhibitors valbenazine (INGREZZA) and deutetrabenazine (AUSTEDO XR) remain the standard of care, though they address symptoms without reversing underlying neurobiological dysfunction. - Emerging therapies including NBI-1065890, SOM3355, LY03015, and ACP-271 are advancing through clinical development, with Neurocrine's NBI-1065890 in Phase II as the most advanced pipeline asset. - Underdiagnosis persists as a major challenge, as involuntary movements are frequently misattributed to psychiatric disorders, medication effects, or normal aging, delaying treatment initiation.
- The CHMP has issued a positive opinion recommending EU approval of Acadia's Daybue (trofinetide) for Rett syndrome following a successful re-examination after an initial rejection in February. - If approved by the European Commission, Daybue would become the first therapy specifically authorized in the EU for the neurobehavioral symptoms of Rett syndrome. - Acadia's Q1 2025 Daybue revenue reached $101 million, representing 20% year-over-year growth, and the company's 2028 sales guidance of $700 million includes European revenue. - The FDA first approved Daybue for Rett syndrome in pediatric and adult patients in 2023, and the drug faces little to no real competition in this indication.
- Acadia Pharmaceuticals projects approximately $1.7 billion in combined net sales by 2028, with NUPLAZID contributing ~$1 billion and DAYBUE ~$700 million. - The company expects Phase 2 RADIANT study results for remlifanserin in Alzheimer's disease psychosis between August and October 2026. - DAYBUE STIX, a new dye- and preservative-free formulation for Rett syndrome, received FDA approval and will launch in Q1 2026. - Remlifanserin represents approximately $4 billion of the company's $11 billion unadjusted full peak sales opportunity across neuropsychiatric indications.
- The FDA has approved DAYBUE STIX, a dye- and preservative-free powder formulation of trofinetide that demonstrates bioequivalence to the original oral solution for treating Rett syndrome in patients aged 2 years and older. - The new formulation can be mixed with water-based liquids, providing caregivers greater flexibility to customize dose volume and taste, particularly beneficial for pediatric patients and those with feeding challenges. - DAYBUE STIX will be available on a limited basis beginning in the first quarter of 2026, with broader availability expected in early second quarter 2026, while the original oral solution remains available. - The approval was supported by bioequivalence data showing comparable systemic exposure between formulations, eliminating the need for additional efficacy trials beyond the original LAVENDER study.
- ResearchAndMarkets.com has released a comprehensive report analyzing licensing deals in biotechnology from 2020 to 2025, providing insights into deal trends and structures. - The report covers hundreds of companies including major players like AbbVie, ACADIA Pharmaceuticals, and emerging biotech firms across various therapeutic areas and technology types. - Key features include financial terms analysis covering upfront payments, milestones, and royalties, plus access to actual contract documents for due diligence purposes. - The analysis enables benchmarking of transaction values and identification of the most active dealmakers in the biotechnology licensing landscape.
- Acadia Pharmaceuticals announced that its Phase 3 COMPASS PWS trial of intranasal carbetocin (ACP-101) failed to demonstrate statistically significant improvement over placebo for hyperphagia in Prader-Willi syndrome patients. - The 12-week randomized, placebo-controlled trial enrolled 175 children and adults aged 5-30 years with PWS, testing carbetocin 3.2 mg three times daily against placebo. - Despite the setback, Acadia maintains its growth outlook with two approved products projected to generate over $1 billion in net sales in 2025 and a robust pipeline including eight disclosed programs. - The company will discontinue further investigation of intranasal carbetocin but plans to share study data with the PWS community for future learning.
- Acadia Pharmaceuticals published interim results from the LOTUS study showing 71-90% of Rett syndrome patients experienced behavioral improvements with DAYBUE treatment over 12 months. - The real-world observational study of 227 patients aged 1-60 years demonstrated improvements in nonverbal communication, alertness, and social interaction consistent with previous clinical trials. - Gastrointestinal side effects remained manageable with diarrhea incidence varying from 23-50% in early weeks to 26-38% in later months, with most cases contained in diapers. - Quality of life scores improved with a median change of 4.6 points on the QI-Disability questionnaire among patients completing 12-month assessments.
