Last reviewed · How we verify

Mifurol (CARMOFUR)

Phase 2 active Small molecule

Mifurol (generic name: CARMOFUR) is a carmofur drug. It is currently in Phase 2 development for Malignant tumor of colon.

Mifurol works by inhibiting the enzyme acid ceramidase, which plays a role in the development and progression of cancer cells.

Mifurol, also known as Carmofur, is a small molecule drug that targets acid ceramidase. It is classified as a carmofur and is used to treat malignant tumors of the colon. The commercial status of Mifurol is unclear, and it is not known if it is patented or available as a generic medication. As a cancer treatment, Mifurol's safety considerations are critical, but specific details are not available. Further research is needed to understand its pharmacokinetic properties and clinical use.

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 nameCARMOFUR
Drug classcarmofur
TargetAcid ceramidase
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 2

Mechanism of action

Think of cancer cells like a city with a strong wall. Acid ceramidase is like a key that helps the cancer cells build and repair their wall, making them stronger. Mifurol blocks this key, making it harder for the cancer cells to grow and spread.

Approved indications

Common side effects

No common side effects on file.

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.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Mifurol

What is Mifurol?

Mifurol (CARMOFUR) is a carmofur drug, indicated for Malignant tumor of colon.

How does Mifurol work?

Mifurol works by inhibiting the enzyme acid ceramidase, which plays a role in the development and progression of cancer cells.

What is Mifurol used for?

Mifurol is indicated for Malignant tumor of colon.

What is the generic name of Mifurol?

CARMOFUR is the generic (nonproprietary) name of Mifurol.

What drug class is Mifurol in?

Mifurol belongs to the carmofur class. See all carmofur drugs at /class/carmofur.

What development phase is Mifurol in?

Mifurol is in Phase 2.

What does Mifurol target?

Mifurol targets Acid ceramidase and is a carmofur.

Related

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