Last reviewed 2026-05-27 · How we verify

NIMUSTINE

Phase 2 active Small molecule Under review Quality 0/100

NIMUSTINE is a nimustine drug. It is currently in Phase 2 development.

Nimustine works by inducing DNA damage through the formation of cross-links and strand breaks.

Nimustine is a small molecule that acts as a DNA disrupting agent. It has been studied in combination with bevacizumab for the treatment of recurrent high-grade glioma, a type of brain cancer.

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	NIMUSTINE
Drug class	nimustine
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 2

Mechanism of action

Imagine your DNA as a long, twisted ladder. Nimustine disrupts this ladder by forming strong chemical bonds between the rungs, making it difficult for the cell to repair the damage. This ultimately leads to cell death, which is beneficial in the context of cancer treatment.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Bevacizumab and Nimustine in Patients With Recurrent High Grade Glioma (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

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

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

Frequently asked questions about NIMUSTINE

What is NIMUSTINE?

NIMUSTINE is a nimustine drug.

How does NIMUSTINE work?

Nimustine works by inducing DNA damage through the formation of cross-links and strand breaks.

What drug class is NIMUSTINE in?

NIMUSTINE belongs to the nimustine class. See all nimustine drugs at /class/nimustine.

What development phase is NIMUSTINE in?

NIMUSTINE is in Phase 2.

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

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