Last reviewed 2026-05-26 · How we verify

Dalnate (TOLINDATE)

Phase 2 active Small molecule ✓ Verified May 2026

Dalnate (generic name: TOLINDATE) is a tolindate drug. It is currently in Phase 2 development.

Dalnate works by interacting with a specific molecular target to produce a therapeutic effect.

Dalnate is a small molecule. It is also known by the synonyms TOLINDATE, TOLINDATE, and TOLINDATO.

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	TOLINDATE
Drug class	tolindate
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and Dalnate is a key that fits into those locks. When it binds to the lock, it helps to regulate the activity of the cell, which can help to treat certain conditions. This is a simplified explanation of how Dalnate works at a molecular level.

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:

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

Frequently asked questions about Dalnate

What is Dalnate?

Dalnate (TOLINDATE) is a tolindate drug.

How does Dalnate work?

Dalnate works by interacting with a specific molecular target to produce a therapeutic effect.

What is the generic name of Dalnate?

TOLINDATE is the generic (nonproprietary) name of Dalnate.

What drug class is Dalnate in?

Dalnate belongs to the tolindate class. See all tolindate drugs at /class/tolindate.

What development phase is Dalnate in?

Dalnate is in Phase 2.

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

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