Last reviewed 2026-05-21 · How we verify

Cymerin (RANIMUSTINE)

Phase 3 active Small molecule ✓ Verified May 2026

Cymerin (generic name: RANIMUSTINE) is a ranimustine drug. It is currently in Phase 3 development.

Cymerin works by interfering with DNA replication and transcription, ultimately leading to cell death.

Cymerin is a small molecule used in the treatment of Adult T-cell Leukemia-Lymphoma. It is administered in combination with VCAP/AMP/VECP(mLSG15) in clinical trials.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	RANIMUSTINE
Drug class	ranimustine
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

Imagine your cells are like factories that make copies of themselves. Cymerin gets inside these factories and messes up their ability to make copies, which eventually kills the factories and stops them from making more copies. This can be helpful in treating certain types of cancer.

Approved indications

No approved indications tracked.

Common side effects

Ventricular hypokinesia
Haemolytic anaemia
Thrombotic microangiopathy
Hepatitis B

Key clinical trials

Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15 (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:

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

Frequently asked questions about Cymerin

What is Cymerin?

Cymerin (RANIMUSTINE) is a ranimustine drug.

How does Cymerin work?

Cymerin works by interfering with DNA replication and transcription, ultimately leading to cell death.

What is the generic name of Cymerin?

RANIMUSTINE is the generic (nonproprietary) name of Cymerin.

What drug class is Cymerin in?

Cymerin belongs to the ranimustine class. See all ranimustine drugs at /class/ranimustine.

What development phase is Cymerin in?

Cymerin is in Phase 3.

What are the side effects of Cymerin?

Common side effects of Cymerin include Ventricular hypokinesia, Haemolytic anaemia, Thrombotic microangiopathy, Hepatitis B.

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

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