Last reviewed 2026-04-20 · How we verify

Ditazol (DITAZOLE)

Phase 2 active Small molecule Quality 24/100

Ditazol (generic name: DITAZOLE) is a ditazole drug. It is currently in Phase 2 development.

Ditazol is thought to work by inhibiting a specific enzyme or protein, although the exact mechanism is unknown.

Ditazol, also known as DITAZOLE, is a small molecule drug in the ditazole class. Its original development is attributed to an unknown entity, and its current ownership is also unclear. The exact target of Ditazol is unknown, and it has not been approved by the FDA for any indications. As a result, there is limited information available on its commercial status, pharmacokinetics, or safety profile. Further research is needed to fully understand Ditazol's properties and potential applications.

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	DITAZOLE
Drug class	ditazole
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have a factory inside them that produces energy. Ditazol is like a key that tries to fit into a lock to stop the factory from working too fast. However, since the exact mechanism is unknown, it's hard to say exactly how it affects the body's energy production.

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:

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

Frequently asked questions about Ditazol

What is Ditazol?

Ditazol (DITAZOLE) is a ditazole drug.

How does Ditazol work?

Ditazol is thought to work by inhibiting a specific enzyme or protein, although the exact mechanism is unknown.

What is the generic name of Ditazol?

DITAZOLE is the generic (nonproprietary) name of Ditazol.

What drug class is Ditazol in?

Ditazol belongs to the ditazole class. See all ditazole drugs at /class/ditazole.

What development phase is Ditazol in?

Ditazol is in Phase 2.

Drug class: All ditazole drugs
Therapeutic area: All drugs in Other

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