Last reviewed 2026-05-27 · How we verify

Vanitiolid (VANITIOLIDE)

Phase 2 active Small molecule ✓ Verified May 2026

Vanitiolid (generic name: VANITIOLIDE) is a vanitiolide drug. It is currently in Phase 2 development.

Vanitiolid is thought to work by interacting with a specific molecular target to produce a therapeutic effect.

Vanitolid is a small molecule with the synonyms NSC-406669, VANITIOLIDA, and VANITIOLIDE.

Likelihood of approval

13.3% 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).
Oncology Phase 2 attrition -2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.

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	VANITIOLIDE
Drug class	vanitiolide
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 2

Mechanism of action

Imagine Vanitiolid as a key that fits into a lock on a cell. When it binds to the lock, it triggers a series of events that ultimately lead to a desired outcome, such as reducing inflammation or killing cancer cells. This process is highly specific and is designed to minimize harm to healthy cells.

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:

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

Frequently asked questions about Vanitiolid

What is Vanitiolid?

Vanitiolid (VANITIOLIDE) is a vanitiolide drug.

How does Vanitiolid work?

Vanitiolid is thought to work by interacting with a specific molecular target to produce a therapeutic effect.

What is the generic name of Vanitiolid?

VANITIOLIDE is the generic (nonproprietary) name of Vanitiolid.

What drug class is Vanitiolid in?

Vanitiolid belongs to the vanitiolide class. See all vanitiolide drugs at /class/vanitiolide.

What development phase is Vanitiolid in?

Vanitiolid is in Phase 2.

Drug class: All vanitiolide drugs
Therapeutic area: All drugs in Oncology

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