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Ceresine (DICHLOROACETIC ACID)

Phase 3 active Small molecule Quality 31/100

Ceresine (generic name: DICHLOROACETIC ACID) is a dichloroacetic acid drug. It is currently in Phase 3 development for Verruca.

Ceresine works by inhibiting an enzyme involved in energy production in cells, which can help to treat warts.

Ceresine, also known as dichloroacetic acid, is a small molecule drug that targets pyruvate dehydrogenase (acetyl-transferring) kinase isozyme 2, mitochondrial. It is used to treat verruca, a type of wart. The commercial status of Ceresine is unknown, and it is not FDA-approved. Key safety considerations include its short half-life of 0.65 hours. Further research is needed to fully understand its pharmacology and potential side effects.

Likelihood of approval
58.3% 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).
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 nameDICHLOROACETIC ACID
Drug classdichloroacetic acid
Target[Pyruvate dehydrogenase (acetyl-transferring)] kinase isozyme 2, mitochondrial
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 3

Mechanism of action

Imagine your cells are like factories that produce energy. Ceresine blocks a key step in this process, which can help to slow down the growth of abnormal cells that cause warts. This can help to reduce the size and appearance of warts over time.

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 Ceresine

What is Ceresine?

Ceresine (DICHLOROACETIC ACID) is a dichloroacetic acid drug, indicated for Verruca.

How does Ceresine work?

Ceresine works by inhibiting an enzyme involved in energy production in cells, which can help to treat warts.

What is Ceresine used for?

Ceresine is indicated for Verruca.

What is the generic name of Ceresine?

DICHLOROACETIC ACID is the generic (nonproprietary) name of Ceresine.

What drug class is Ceresine in?

Ceresine belongs to the dichloroacetic acid class. See all dichloroacetic acid drugs at /class/dichloroacetic-acid.

What development phase is Ceresine in?

Ceresine is in Phase 3.

What does Ceresine target?

Ceresine targets [Pyruvate dehydrogenase (acetyl-transferring)] kinase isozyme 2, mitochondrial and is a dichloroacetic acid.

Related

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