Last reviewed 2026-05-27 · How we verify

AMRUBICIN

Phase 3 active Small molecule Under review Quality 10/100

AMRUBICIN is a amrubicin drug. It is currently in Phase 3 development.

Amrubicin works by inserting itself between DNA strands, disrupting the cell's ability to repair DNA damage and leading to cell death.

Amrubicin is a small molecule that inhibits DNA topoisomerase 2-alpha, a type of enzyme involved in DNA replication. It has been studied in clinical trials for various conditions, including metastatic breast cancer, thymoma, thymus cancer, thymic carcinoma, and small cell lung cancer.

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	AMRUBICIN
Drug class	amrubicin
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

Imagine your DNA as a long, twisted ladder. Amrubicin gets in between the rungs of the ladder, making it hard for the cell to fix any mistakes in the DNA. This ultimately leads to the cell dying, which is what we want when treating cancer.

Approved indications

No approved indications tracked.

Common side effects

Anaemia
Nausea
Neutropenia
Fatigue
Thrombocytopenia
Leukopenia
Constipation
Decreased appetite
Platelet count decreased
Neutrophil count decreased
Diarrhoea
Asthenia

Key clinical trials

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:

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

Frequently asked questions about AMRUBICIN

What is AMRUBICIN?

AMRUBICIN is a amrubicin drug.

How does AMRUBICIN work?

Amrubicin works by inserting itself between DNA strands, disrupting the cell's ability to repair DNA damage and leading to cell death.

What drug class is AMRUBICIN in?

AMRUBICIN belongs to the amrubicin class. See all amrubicin drugs at /class/amrubicin.

What development phase is AMRUBICIN in?

AMRUBICIN is in Phase 3.

What are the side effects of AMRUBICIN?

Common side effects of AMRUBICIN include Anaemia, Nausea, Neutropenia, Fatigue, Thrombocytopenia, Leukopenia.

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

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