Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST)
← catalyst calendarSponsored by Tonix Pharmaceuticals, Inc. (industry) · TNXP — their whole pipeline →. With National Institute on Drug Abuse (NIDA), Premier.
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Tonix has discontinued enrollment and terminated the Phase 2 CATALYST study (TNX-CE-CI202) because enrollment in this emergency department-based study was slower than projected. The study was not discontinued for safety or efficacy reasons.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-08-16 | actual | When the study began enrolling |
| Primary completion | 2025-04-21 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-04-21 | actual | The whole study's end, after follow-up |
| First posted | 2023-09-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-06-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Cocaine Use
- Cocaine Intoxication
- Cocaine Toxicity
- Cocaine Abuse
- Cocaine Adverse Reaction
Interventions
- Drug: TNX-1300 (Injection) — also filed as Cocaine esterase
- Drug: Placebo (Injection)
Primary outcome
what the primary-completion date above is the date OFPermalink · TNXP's whole pipeline · Catalyst calendar · Every registered study · What changed