Last reviewed 2026-04-19 · How we verify

CYCLOGUANIL

Phase 2 active Small molecule

CYCLOGUANIL is a drug. It is currently in Phase 2 development.

Cycloguanil works by blocking the enzyme dihydrofolate reductase, which is necessary for DNA synthesis in certain cells.

Cycloguanil is a small molecule drug that targets dihydrofolate reductase, an enzyme involved in DNA synthesis. It is not clear if it is FDA approved or commercially available, and its patent status is unknown. Cycloguanil works by inhibiting the enzyme, which is necessary for the growth and replication of certain cells. It is used to treat malaria, but its exact indications and commercial status are unclear. Further research is needed to determine its safety and efficacy.

Likelihood of approval

15.3% 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).

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 name	CYCLOGUANIL
Target	Dihydrofolate reductase, Bifunctional dihydrofolate reductase-thymidylate synthase, Dihydrofolate reductase
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of DNA like a blueprint for your body. Dihydrofolate reductase is an enzyme that helps build this blueprint. Cycloguanil stops this enzyme from working, which can help prevent the growth and replication of certain cells, like the parasites that cause malaria.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

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

Frequently asked questions about CYCLOGUANIL

What is CYCLOGUANIL?

CYCLOGUANIL is a Small molecule drug.

How does CYCLOGUANIL work?

Cycloguanil works by blocking the enzyme dihydrofolate reductase, which is necessary for DNA synthesis in certain cells.

What development phase is CYCLOGUANIL in?

CYCLOGUANIL is in Phase 2.

What does CYCLOGUANIL target?

CYCLOGUANIL targets Dihydrofolate reductase, Bifunctional dihydrofolate reductase-thymidylate synthase, Dihydrofolate reductase.

Target: All drugs targeting Dihydrofolate reductase, Bifunctional dihydrofolate reductase-thymidylate synthase, Dihydrofolate reductase
Therapeutic area: All drugs in Other

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