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NCT06045793: CATALYST
Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST)
Phase 2 trial testing TNX-1300 (Injection) in Cocaine Use in 3 participants. Terminated before completion.
21 April 2025
Quick facts
| Lead sponsor | Tonix Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 3 |
| Start date | 16 August 2024 |
| Primary completion | 21 April 2025 |
| Estimated completion | 21 April 2025 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- TNX-1300 (Injection) — full drug profile →
- Placebo (Injection)
Conditions studied
- Cocaine Use — all drugs for Cocaine Use →
- Cocaine Intoxication — all drugs for Cocaine Intoxication →
- Cocaine Toxicity — all drugs for Cocaine Toxicity →
- Cocaine Abuse — all drugs for Cocaine Abuse →
Sponsor
Tonix Pharmaceuticals, Inc. — full company profile →
Who can join
Adults 18 to 64, any sex, with Cocaine Use or Cocaine Intoxication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 2 single-blind, randomized, multicenter study to compare the efficacy and safety of a single dose of TNX-1300 to placebo with usual care in patients with acute cocaine intoxication within the emergency department setting.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06045793
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cocaine Use
Currently open trials in the same condition.
- NCT05766631 — Treating Polysubstance Use Using a Novel Digital Technology · Phase 3 · recruiting
Other Tonix Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT07413367 — A Phase 1, Open-Label, Parallel-Group, Single-Dose Study To Compare The Pharmakokinetics Of TNX-102 SL (Cyclobenzaprine · Phase 1 · active not recruiting
- NCT07473752 — A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Escalation Study to Evaluate the Safety, · Phase 1 · completed
- NCT05686408 — Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD) · Phase 2 · completed
- NCT05679908 — A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine · Phase 2 · completed
- NCT05372887 — Safety and Efficacy Study of TNX-102 SL in Participants With PTSD · Phase 2 · withdrawn
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 NCT06045793 (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 Tonix Pharmaceuticals, Inc.
- Last refreshed: 24 June 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/NCT06045793.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing