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CHLORPROGUANIL

Phase 3 active Small molecule

CHLORPROGUANIL is a chlorproguanil drug. It is currently in Phase 3 development.

Chlorproguanil works by inhibiting the enzyme dihydrofolate reductase, which is necessary for the growth and replication of malaria parasites.

Chlorproguanil is a small molecule drug in the chlorproguanil class, originally developed by an unknown entity. Its current owner is also unknown. The exact target of chlorproguanil is not specified, but it is used to treat malaria. The commercial status of chlorproguanil is unclear, with unknown patent status and generic manufacturers. Key safety considerations are not well-documented.

Likelihood of approval
59.3% 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).
  • Immunology slight uplift +1.0pp
    Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
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 nameCHLORPROGUANIL
Drug classchlorproguanil
ModalitySmall molecule
Therapeutic areaImmunology
PhasePhase 3

Mechanism of action

Think of it like a roadblock for the parasite's growth. Chlorproguanil blocks an enzyme that the parasite needs to make its own DNA, which is essential for it to multiply and cause illness. Without this enzyme, the parasite can't grow and multiply, allowing the body's immune system to fight it off.

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 CHLORPROGUANIL

What is CHLORPROGUANIL?

CHLORPROGUANIL is a chlorproguanil drug.

How does CHLORPROGUANIL work?

Chlorproguanil works by inhibiting the enzyme dihydrofolate reductase, which is necessary for the growth and replication of malaria parasites.

What drug class is CHLORPROGUANIL in?

CHLORPROGUANIL belongs to the chlorproguanil class. See all chlorproguanil drugs at /class/chlorproguanil.

What development phase is CHLORPROGUANIL in?

CHLORPROGUANIL is in Phase 3.

Related

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