Last reviewed 2026-04-20 · How we verify

Ivertol (AMBAZONE)

Phase 2 active Small molecule

Ivertol (generic name: AMBAZONE) is a ambazone drug. It is currently in Phase 2 development.

Ivertol works by binding to a specific target, but the exact target is unknown.

Ivertol (AMBAZONE) is a small molecule drug in the ambazone class, but specific details about its development, approval status, and indications are not available. As a result, there is limited information about its commercial status, safety considerations, and pharmacokinetic properties. Further research is needed to understand the specifics of Ivertol. The exact target of Ivertol is also unknown. It is essential to consult reliable sources for accurate information about this drug.

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	AMBAZONE
Drug class	ambazone
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine a key fitting into a lock - Ivertol is like a key that binds to a specific lock on a cell, but we don't know what that lock does yet. This binding action can help to either block or enhance a particular process in the body, but the details are still unclear.

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:

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

Frequently asked questions about Ivertol

What is Ivertol?

Ivertol (AMBAZONE) is a ambazone drug.

How does Ivertol work?

Ivertol works by binding to a specific target, but the exact target is unknown.

What is the generic name of Ivertol?

AMBAZONE is the generic (nonproprietary) name of Ivertol.

What drug class is Ivertol in?

Ivertol belongs to the ambazone class. See all ambazone drugs at /class/ambazone.

What development phase is Ivertol in?

Ivertol is in Phase 2.

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

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