Drugs / Aticaprant

Trials 17

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 17 trials
Phase 1 NCT07615426 Mar 2026 → Jun 2027 expected schizophrenia Janssen Research & Development, LLC Recruiting No outcome recorded
Phase 1 NCT05387759 May → Oct 2022 — Janssen Research & Development, LLC Completed No outcome recorded
Phase 1 NCT05197062 Jan → Mar 2022 — Janssen Research & Development, LLC Completed No outcome recorded
Phase 1 NCT04791332 Apr → Jul 2021 — Janssen Pharmaceutical K.K. Completed No outcome recorded
Phase 1 NCT04185051 Dec 2019 → Apr 2021 — Janssen Research & Development, LLC Completed No outcome recorded
Phase 1 NCT02218775 Oct 2014 → Apr 2015 anxiety disorder Andrew Krystal Withdrawn No outcome recorded Stop: Business
Phase 1 NCT01232439 Dec 2010 → Apr 2011 alcohol dependence Eli Lilly and Company Completed No outcome recorded
Phase 25 trials · 2 met primary · 1 missed
Phase 2 NCT03559192 Jul 2018 → May 2020 major depressive disorder Janssen Research & Development, LLC Completed Met primary
Phase 2 NCT02800928 Jun 2016 → Jan 2018 — Yale University Completed No outcome recorded
Phase 2 NCT02641028 Dec 2015 → Sep 2016 — Janssen Research & Development, LLC Completed Missed primary
Phase 2 NCT02218736 Jun 2015 → Nov 2017 anxiety disorder Duke University Completed Met primary
Phase 2 NCT01913535 Sep 2013 → Jan 2016 — Massachusetts General Hospital Terminated No outcome recorded Stop: Enrollment
Phase 35 trials · 2 missed
Phase 3 NCT06635135 Sep 2024 → Apr 2025 atypical depressive disorder, major depressive disorder Janssen Research & Development, LLC Terminated No outcome recorded
Phase 3 NCT06514742 Jun 2024 → Apr 2025 atypical depressive disorder, major depressive disorder Janssen Research & Development, LLC Terminated No outcome recorded
Phase 3 NCT05550532 Dec 2022 → Nov 2024 major depressive disorder Janssen Research & Development, LLC Completed Missed primary
Phase 3 NCT05518149 Sep 2022 → Apr 2025 major depressive disorder Janssen Research & Development, LLC Terminated No outcome recorded
Phase 3 NCT05455684 Jun 2022 → Sep 2024 atypical depressive disorder, major depressive disorder Janssen Research & Development, LLC Completed Missed primary

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2025-03-06 Janssen Research & Development, LLC Results Johnson & Johnson Statement on VENTURA Program jnj.com ↗
Johnson & Johnson has made the decision to discontinue the Phase 3 VENTURA development program evaluating aticaprant as an adjunctive treatment for major depressive disorder (aMDD) due to insufficient efficacy in the target patient population.
2017-05-01 Avalo Therapeutics, Inc. Results Cerecor Reports Encouraging Topline Data from a NIH Sponsored Proof-of-Concept Trial of CERC-501 in Treatment-Resistant Depression May 01, 2017 8:30am EDT avalotx.com ↗
CERC-501 showed a clinically meaningful 2.0-point difference from placebo on the Hamilton Rating Scale for Depression - 6 - items ("HAM-D-6"), change from baseline to 72 hours, which served as the primary efficacy measure.
2016-12-05 Avalo Therapeutics, Inc. Results Cerecor Announces Top-Line Results from CERC-501 Phase 2 Study for Nicotine Withdrawal December 05, 2016 8:00am EST avalotx.com ↗
The trial did not meet its primary objective in nicotine withdrawal.
2015-12-11 Avalo Therapeutics, Inc. Results Publication Reports Human Brain Penetration and Target Engagement of Cerecor’s Oral Kappa Opioid Receptor Antagonist, CERC-501 December 11, 2015 9:15am EST avalotx.com ↗
In this study of healthy volunteers, CERC-501 demonstrated reproducible penetration of the blood-brain barrier and target engagement, as shown through PET (positron emission tomography) imaging.

All press releases naming this drug 9 releases

DateIssuerRelease

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 18 sources stand behind the page.

FieldValueCited text
Known as Aticaprant ClinicalTrials.gov intervention name — accepted as the source's own label NCT05518149 ↗
7

NCT06635135 ↗

NCT06514742 ↗

NCT07615426 ↗

NCT05197062 ↗

NCT05455684 ↗

NCT05550532 ↗

NCT05387759 ↗

Known as CERC-501 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02218736 ↗
3

NCT01913535 ↗

NCT02800928 ↗

NCT02641028 ↗

Known as JNJ-67953964 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04185051 ↗
2

NCT04791332 ↗

NCT03559192 ↗

Known as JNJ-67953964-AAA ChEMBL registry synonym — accepted as the source's own label CHEMBL1921847 ↗
Known as JSPA-0658 ChEMBL registry synonym — accepted as the source's own label CHEMBL1921847 ↗
Known as LY2456302 “Assessment of Brain Kappa Opioid Receptor Occupancy After Single Oral Doses of LY2456302 as Measured by PET With Radioligand LY2879788 in Healthy Subjects” NCT01232439 ↗
2

“CERC-501 (formerly known as LY2456302)” NCT02218736 ↗

NCT02218775 ↗

Action Inhibit “opioid receptor kappa antagonist” NCT01232439 ↗
1

“Kappa opioid receptor antagonist” CHEMBL1921847 ↗

Modality Small molecule — CHEMBL1921847 ↗
Route Oral “administered orally” NCT01232439 ↗
Target OPRK1 “Kappa opioid receptor antagonist” CHEMBL1921847 ↗