Clinical Trials
105
61 active
Approvals
5
Total approvals
Agencies
2
Regulatory bodies
Founded
1993
Active, not recruiting
58
55.2%
Approved For Marketing
1
0.9%
Completed
27
25.7%
Enrolling By Invitation
2
1.9%
Not yet recruiting
1
0.9%
Recruiting
8
7.6%
Terminated
8
7.6%
- 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.
