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NCT07253324
ENX-104 MAD Study for Participants With Major Depressive Disorder With Anhedonia (aMDD)
Phase 1 trial testing ENX-104 in Major Depressive Disorder in 48 participants. Completed in 26 November 2025.
26 November 2025
Quick facts
| Lead sponsor | Engrail Therapeutics INC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 17 February 2025 |
| Primary completion | 26 November 2025 |
| Estimated completion | 26 November 2025 |
| Sites | 4 locations across United Kingdom |
Drugs / interventions tested
- ENX-104 — full drug profile →
- Placebo
Conditions studied
- Major Depressive Disorder — all drugs for Major Depressive Disorder →
Sponsor
Engrail Therapeutics INC — full company profile →
Who can join
Adults 18 to 65, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ENX-104 in participants with major depressive disorder with anhedonia (aMDD).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07253324
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ENX-104
Trials testing the same drug.
- NCT07253272 — A PET Study of ENX-104 in Healthy Volunteers · Phase 1 · completed
Other recruiting trials for Major Depressive Disorder
Currently open trials in the same condition.
- NCT07219394 — Peer-Delivered Behavioral Activation in a CCBHC · NA · recruiting
- NCT06705478 — Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disor · Phase 2 · recruiting
- NCT06749392 — An Individual-specific Synchrony Signature · NA · recruiting
- NCT07316803 — Group Intervention for Romantic Relationships in Young Adults With Severe Mental Illness · NA · recruiting
- NCT07242105 — Optimizing Brain Excitability in Depression · NA · recruiting
Other Engrail Therapeutics INC trials
Trials by the same sponsor.
- NCT07193563 — A Study to Evaluate the Efficacy and Safety of ENX-102 in Participants With Social Anxiety Disorder · Phase 2 · completed
- NCT07253272 — A PET Study of ENX-104 in Healthy Volunteers · Phase 1 · completed
- NCT06653296 — A Dose-Response Safety Study of ENX-102 in Patients With GAD · Phase 2 · completed
- NCT05749055 — ENCALM: A Study of ENX-102 as a Monotherapy Treatment in Patients With Generalized Anxiety Disorder · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07253324 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Engrail Therapeutics INC
- Last refreshed: 31 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07253324.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing