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INTOPLICINE

Phase 2 active Small molecule

INTOPLICINE is a intoplicine drug. It is currently in Phase 2 development.

INTOPLICINE works by binding to and inhibiting DNA topoisomerase 1, an enzyme that helps cancer cells replicate and repair their DNA.

INTOPLICINE is a small molecule drug that targets DNA topoisomerase 1, a key enzyme involved in DNA replication and repair. It is classified as an intoplicine, a class of drugs that inhibit this enzyme, thereby preventing cancer cell growth. However, its commercial status and approved indications are unknown. As a result, its availability and use are not established. Further research is needed to determine its potential as a cancer treatment.

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 nameINTOPLICINE
Drug classintoplicine
TargetDNA topoisomerase 1, DNA topoisomerase 2-alpha, DNA topoisomerase I, mitochondrial
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 2

Mechanism of action

Think of DNA topoisomerase 1 like a pair of scissors that helps cut and repair DNA. INTOPLICINE blocks these scissors, making it harder for cancer cells to grow and divide. This can help slow or stop the growth of cancer.

Approved indications

No approved indications tracked.

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 INTOPLICINE

What is INTOPLICINE?

INTOPLICINE is a intoplicine drug.

How does INTOPLICINE work?

INTOPLICINE works by binding to and inhibiting DNA topoisomerase 1, an enzyme that helps cancer cells replicate and repair their DNA.

What drug class is INTOPLICINE in?

INTOPLICINE belongs to the intoplicine class. See all intoplicine drugs at /class/intoplicine.

What development phase is INTOPLICINE in?

INTOPLICINE is in Phase 2.

What does INTOPLICINE target?

INTOPLICINE targets DNA topoisomerase 1, DNA topoisomerase 2-alpha, DNA topoisomerase I, mitochondrial and is a intoplicine.

Related

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