Last reviewed · How we verify
Aticaprant Therapeutic Dose
Aticaprant Therapeutic Dose is a Kappa opioid receptor antagonist Small molecule drug developed by Janssen Research & Development, LLC. It is currently in Phase 1 development. Also known as: JNJ-67953964.
Aticaprant blocks kappa opioid receptors in the brain, potentially improving mood regulation and reducing depressive symptoms.
Aticaprant is a small molecule kappa opioid receptor antagonist, classified as an antagonist. The therapeutic dose of aticaprant has been studied in clinical trials for treatment-resistant depression.
-
Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Janssen Research & Development, LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Aticaprant Therapeutic Dose |
|---|---|
| Also known as | JNJ-67953964 |
| Sponsor | Janssen Research & Development, LLC |
| Drug class | Kappa opioid receptor antagonist |
| Modality | Small molecule |
| Phase | Phase 1 |
Mechanism of action
Aticaprant is a selective kappa opioid receptor antagonist. By blocking KOR, it prevents the dysphoric and stress-inducing effects mediated by this receptor system. This mechanism represents a novel approach to treating depression that differs from traditional monoamine-based antidepressants.
Approved indications
Common side effects
Key clinical trials
- A Thorough QT Study of Aticaprant (JNJ-67953964) in Healthy Adult Participants (PHASE1)
- Proof-of-Concept Trial of CERC-501 Augmentation of Antidepressant Therapy in Treatment-Resistant Depression (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Aticaprant Therapeutic Dose CI brief — competitive landscape report
- Aticaprant Therapeutic Dose updates RSS · CI watch RSS
- Janssen Research & Development, LLC portfolio CI
Frequently asked questions about Aticaprant Therapeutic Dose
What is Aticaprant Therapeutic Dose?
How does Aticaprant Therapeutic Dose work?
Who makes Aticaprant Therapeutic Dose?
Is Aticaprant Therapeutic Dose also known as anything else?
What drug class is Aticaprant Therapeutic Dose in?
What development phase is Aticaprant Therapeutic Dose in?
Related
- Drug class: All Kappa opioid receptor antagonist drugs
- Manufacturer: Janssen Research & Development, LLC — full pipeline
- Also known as: JNJ-67953964
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing