intranasal carbetocin (ACP-101) / Acadia Pharma - LARVOL DELTA

Signature motif identification and enzymatic characterization of a protein tyrosine phosphatase in Metarhizium anisopliae (PubMed, Sheng Wu Gong Cheng Xue Bao) - "Functional analysis confirmed that the L-protein retained the PTP activity despite the absence of arginine in its signature motif, while AcP101 functioned as an acid phosphatase. This study provides the first functional validation of an arginine-deficient PTP motif, expanding the definition of PTP signature motifs and offering new insights for phosphatase classification."

Journal

Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome (clinicaltrials.gov) - P3 | N=170 | Active, not recruiting | Sponsor: ACADIA Pharmaceuticals Inc. | Trial completion date: Jun 2026 ➔ Nov 2025 | Trial primary completion date: May 2026 ➔ Oct 2025

Trial completion date • Trial primary completion date • Prader–Willi syndrome

Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome (clinicaltrials.gov) - P3 | N=170 | Active, not recruiting | Sponsor: ACADIA Pharmaceuticals Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Prader–Willi syndrome

Acadia Pharmaceuticals Provides Business and Pipeline Updates at 43rd Annual J.P. Morgan Healthcare Conference (Businesswire) - "Key 2025-2026 Milestones...Initiation of Managed Access Programs in Europe in the second quarter of 2025, potentially resulting in the Company’s first revenues from outside the U.S; Enrollment of the last patient in the COMPASS PWS Phase 3 study of ACP-101 in Prader-Willi Syndrome anticipated in the fourth quarter of 2025, followed by top-line results announcement in the first half of 2026; Enrollment of the last patient in the RADIANT Phase 2 study of ACP-204 in Alzheimer’s disease psychosis expected in the first quarter of 2026, followed by top-line results announcement in mid-2026."

Commercial • Enrollment status • P2 data • P3 data: top line • Alzheimer's Disease • CNS Disorders • Prader–Willi syndrome

OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome (clinicaltrials.gov) - P3 | N=160 | Enrolling by invitation | Sponsor: ACADIA Pharmaceuticals Inc.

New P3 trial • Prader–Willi syndrome

Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome (clinicaltrials.gov) - P3 | N=170 | Recruiting | Sponsor: ACADIA Pharmaceuticals Inc. | Enrolling by invitation ➔ Recruiting

Enrollment status • Prader–Willi syndrome

Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome (clinicaltrials.gov) - P3 | N=170 | Enrolling by invitation | Sponsor: ACADIA Pharmaceuticals Inc.

New P3 trial • Prader–Willi syndrome

Intranasal Carbetocin Reduces Hyperphagia, Anxiousness and Distress in Prader-Willi Syndrome: CARE-PWS Phase 3 Trial. (PubMed, J Clin Endocrinol Metab) - "Carbetocin was well tolerated, and the 3.2 mg dose was associated with clinically meaningful improvements in hyperphagia and anxiousness and distress behaviors in participants with PWS."

Journal • P3 data • Genetic Disorders • Infectious Disease • Mood Disorders • Novel Coronavirus Disease • Prader–Willi syndrome • Psychiatry

The Prader-Willi Syndrome Anxiousness and Distress Behaviors Questionnaire: Development and Psychometric Validation. (PubMed, Value Health) - "The current body of evidence supports the conclusion that the PADQ measures observable behaviors that are meaningful to patients and their families and provides a valid and reliable method to assess beneficial treatment effects for some of the most challenging behaviors associated with PWS."

Journal • Mood Disorders • Prader–Willi syndrome • Psychiatry

CARE-PWS: Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - P3 | N=130 | Completed | Sponsor: Levo Therapeutics, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Jul 2022

Trial completion • Trial completion date • Prader–Willi syndrome

CARE-PWS: Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - P3; N=130; Active, not recruiting; Sponsor: Levo Therapeutics, Inc.; Trial completion date: Jun 2021 ➔ Dec 2022

Clinical • Trial completion date • Prader–Willi syndrome

[VIRTUAL] Topline Results of the CARE-PWS Phase 3 Study: Intranasal Carbetocin Improves Hyperphagia and Anxiety and Distress Symptoms in Prader-Willi Syndrome (PWS) (ENDO 2021) - "For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021."

P3 data • P3 data: top line • Infectious Disease • Mood Disorders • Novel Coronavirus Disease • Prader–Willi syndrome • Psychiatry

CARE-PWS: Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - P3; N=175; Active, not recruiting; Sponsor: Levo Therapeutics, Inc.; Suspended ➔ Active, not recruiting

Clinical • Enrollment closed • Prader–Willi syndrome

CARE-PWS: Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - P3; N=175; Suspended; Sponsor: Levo Therapeutics, Inc.; Recruiting ➔ Suspended

Clinical • Trial suspension