Last reviewed 2026-05-23 · How we verify

TOLONIDINE

Phase 2 active Small molecule ✓ Verified May 2026

TOLONIDINE is a tolonidine drug. It is currently in Phase 2 development.

Tolonidine is thought to work by interacting with the body's central nervous system to produce a specific effect.

Tolonidine is a small molecule medication. It is also known by other names, including ST 375, ST-375, Tolonidina, and Tolonidine.

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	TOLONIDINE
Drug class	tolonidine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your brain as a computer, and the chemicals in your brain as the software that makes it work. Tolonidine is like a new piece of software that is designed to interact with the existing software in your brain to produce a specific effect. However, the exact details of how it works are not yet understood.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

TOLONIDINE CI brief — competitive landscape report
TOLONIDINE updates RSS · CI watch RSS

Frequently asked questions about TOLONIDINE

What is TOLONIDINE?

TOLONIDINE is a tolonidine drug.

How does TOLONIDINE work?

Tolonidine is thought to work by interacting with the body's central nervous system to produce a specific effect.

What drug class is TOLONIDINE in?

TOLONIDINE belongs to the tolonidine class. See all tolonidine drugs at /class/tolonidine.

What development phase is TOLONIDINE in?

TOLONIDINE is in Phase 2.

Drug class: All tolonidine drugs
Therapeutic area: All drugs in Other

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