Last reviewed 2026-06-03 · How we verify

TNX-601 ER

Tonix Pharmaceuticals, Inc. · Phase 2 active Small molecule ✓ Verified May 2026 Quality 10/100

TNX-601 ER is a Small molecule drug developed by Tonix Pharmaceuticals, Inc.. It is currently in Phase 2 development. Also known as: Tianeptine.

TNX-601 ER is a small molecule being studied as a potential treatment for major depressive disorder (MDD). It is being evaluated in a Phase 2 clinical trial as a monotherapy compared to a placebo.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	TNX-601 ER
Also known as	Tianeptine
Sponsor	Tonix Pharmaceuticals, Inc.
Modality	Small molecule
Phase	Phase 2

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD) (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:

TNX-601 ER CI brief — competitive landscape report
TNX-601 ER updates RSS · CI watch RSS
Tonix Pharmaceuticals, Inc. portfolio CI

Frequently asked questions about TNX-601 ER

What is TNX-601 ER?

TNX-601 ER is a Small molecule drug developed by Tonix Pharmaceuticals, Inc..

Who makes TNX-601 ER?

TNX-601 ER is developed by Tonix Pharmaceuticals, Inc. (see full Tonix Pharmaceuticals, Inc. pipeline at /company/tonix-pharmaceuticals-inc).

Is TNX-601 ER also known as anything else?

TNX-601 ER is also known as Tianeptine.

What development phase is TNX-601 ER in?

TNX-601 ER is in Phase 2.

Manufacturer: Tonix Pharmaceuticals, Inc. — full pipeline
Also known as: Tianeptine

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing