Aticaprant Drug Asset Due Diligence Report 2026

This Aticaprant Drug Asset Due Diligence Report was built with PatSnap Life Sciences MCP workflows. Drug & Asset MCP establishes identity, ownership and stage; Clinical Trials MCP checks design, endpoints and readouts; Company & Deal Intelligence MCP reconstructs transaction precedent. Explore the MCP servers used in this report.

Decision date: 15 July 2026. Currency fields are presented in US$ millions as returned by the deal dataset. This is a screening memorandum, not legal, medical, patent or investment advice.

Phase 3

Highest phase

Registered trials

Result records

Matched deals

Executive recommendation: GO

Decision memo

Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.

The central underwriting question is whether Aticaprant can convert its Small molecule drug profile and κ opioid receptor biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Aticaprant (query alias: aticaprant)
Modality / target	Small molecule drug; κ opioid receptor; κ opioid receptor antagonists
Highest global status	Phase 3
Originator	National Institute of Mental Health
Active developers	Janssen-Cilag International NV, Janssen Research & Development LLC

The MCP disease footprint includes Anhedonia, Depressive Disorder, Major, Schizophrenia. The highest-phase flag is a useful orientation point, but the licensing case depends on indication-level evidence and rights, not the global label alone.

2. Clinical program: design and endpoint audit

Registry	Phase	Status	Enrollment	Lead primary endpoint
NCT06514742	Phase 3	Terminated	101	Change From Baseline to Day 43 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
NCT06635135	Phase 3	Terminated	47	Time From Randomization Into Double Blind (DB) Treatment Maintenance Phase to the First Documentation of Relapse
NCT07615426	Phase 1	Recruiting	64	Screen Pass Rate

The trial set should be diligenced for randomization, comparator relevance, endpoint hierarchy, analysis population, multiplicity, geographic mix and readout timing. For early-stage studies, safety and dose selection can be as decision-critical as response rate.

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3. Clinical readouts: what is known

A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjunctive Aticaprant Plus an Antidepressant for Relapse Prevention in Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia

Phase 3; n=47; evaluation: not stated. Reported fields: -; Time From Randomization Into Double Blind (DB) Treatment Maintenance Phase to the First Documentation of Relapse(Median) = NA days (Full Range, NA - NA); -

A Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy

Phase 3; n=444; evaluation: not stated. Reported fields: Change From Baseline to Day 43 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(Least Squares Mean) = -9.4 Units on a scale (Standard Error, 0.96); Change From Baseline to Day 43 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(Least Squares Mean): Least Square Mean Difference = -0.5(95% CI, -2.95 to 1.90), P-Value = 0.670; Change From Baseline to Day 43 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(Least Squares Mean): Least Square Mean Difference = -0.5(95% CI, -2.95 to 1.90), P-Value = 0.670

A Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy

Phase 3; n=513; evaluation: not stated. Reported fields: Change From Baseline to Day 43 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(Least Squares Mean) = -11.4 Units on a scale (Standard Error, 0.98); Change From Baseline to Day 43 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(Least Squares Mean): Least Square Mean Difference = -0.9(95% CI, -3.24 to 1.49), P-Value = 0.467; Change From Baseline to Day 43 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(Least Squares Mean): Least Square Mean Difference = -0.9(95% CI, -3.24 to 1.49), P-Value = 0.467

These fields are structured evidence signals, not a substitute for statistical review. The next diligence pass should reconcile denominators, confidence intervals, follow-up, censoring, dose cohorts and treatment-emergent toxicity against the original abstract, registry and protocol.

4. Market and competitive position

Aticaprant addresses Anhedonia, Depressive Disorder, Major, Schizophrenia. Commercial attractiveness rests on addressable biomarker-positive patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Small molecule drug—must demonstrate a benefit large enough to offset class-specific safety and operational costs.

The strongest market-validation signal in this screen is partner behavior: 2 matched transaction record(s) indicate that sophisticated counterparties have assigned strategic value to the asset or its rights. That does not establish net present value; probability of success, remaining R&D spend, royalties, cost sharing and territorial scope still need modeling.

5. Transaction precedent and economics

Date	Transaction	Phase at deal	Disclosed economics
2017-08-14	Cerecor Announces Divestiture of CERC-501 to Janssen Pharmaceuticals, Inc.	Phase 2	US$20.0M milestones; US$25.0M stated total
2015-02-20	Cerecor Inc. Bolsters Clinical Pipeline With Acquisition Of Phase 2-Ready Kappa Opioid Receptor Antagonist From Eli Lilly	Phase 2	Financial terms not disclosed

Headline values are not directly comparable. Diligence should normalize upfront cash, equity, development and sales milestones, tiered royalties, opt-in mechanics, cost sharing, change-of-control clauses and geography.

6. IP and freedom-to-operate screen

The milestone feed surfaced a patent-application signal described as “Compositions comprising aticaprant for use in treating major depressive disorder”. The milestone feed surfaced a patent-application signal described as “Composition of opioid receptor modulator and MDMA for use thereof”. The milestone feed surfaced a patent-application signal described as “Polymorph forms of aticaprant for use in treating major depressive disorder”.

The claim chart should separately test composition or sequence coverage, formulation and dosing, indication and biomarker claims, combinations, manufacturing know-how, prosecution history, term extensions and third-party blocking rights. Confirm that licensed patents, data and know-how track every granted territory and field.

7. Principal risks and diligence gates

Therapeutic index across KRAS/BRAF mutation subgroups
On-target toxicity and adaptive MAPK resistance
Lack of matched efficacy results in the current MCP result set

Cross-functional diligence should also test CMC comparability, supply chain, pharmacovigilance, regulatory correspondence, data integrity, investigator concentration, partner obligations and change-of-control restrictions.

8. Final go/no-go memorandum

GO