Last reviewed 2026-04-20 · How we verify

Mannomustin (MANNOMUSTINE)

Phase 2 active Small molecule

Mannomustin (generic name: MANNOMUSTINE) is a mannomustine drug. It is currently in Phase 2 development.

Mannomustin is thought to work by interfering with cellular processes, but the exact mechanism is not well understood.

Mannomustin (MANNOMUSTINE) is a small molecule drug in the mannomustine class, but its target and mechanism of action are unknown. Its commercial status and approved indications are also unclear. As a result, key safety considerations and pharmacokinetic properties such as half-life and bioavailability are not well established. Further research is needed to fully understand this compound. Its ownership and patent status are also unknown.

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	MANNOMUSTINE
Drug class	mannomustine
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 2

Mechanism of action

Imagine your cells are like a factory, and mannomustin is a tool that disrupts the factory's ability to make copies of itself. This can help slow down the growth of cancer cells, but it's a complex process and more research is needed to fully understand how it works.

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:

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

Frequently asked questions about Mannomustin

What is Mannomustin?

Mannomustin (MANNOMUSTINE) is a mannomustine drug.

How does Mannomustin work?

Mannomustin is thought to work by interfering with cellular processes, but the exact mechanism is not well understood.

What is the generic name of Mannomustin?

MANNOMUSTINE is the generic (nonproprietary) name of Mannomustin.

What drug class is Mannomustin in?

Mannomustin belongs to the mannomustine class. See all mannomustine drugs at /class/mannomustine.

What development phase is Mannomustin in?

Mannomustin is in Phase 2.

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

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