Last reviewed 2026-04-20 · How we verify

Nitrothiazol (NIRIDAZOLE)

Phase 2 active Small molecule

Nitrothiazol (generic name: NIRIDAZOLE) is a niridazole drug. It is currently in Phase 2 development.

Niridazole works by interfering with the metabolic processes of certain parasites, ultimately leading to their death.

Nitrothiazol, also known as Niridazole, is a small molecule drug in the niridazole class. Its exact target is unknown, but it is used to treat certain parasitic infections. The commercial status of Niridazole is unclear, and it may be patented or available as a generic medication. Key safety considerations are not well-documented. Niridazole's mechanism of action and pharmacokinetic properties are also not well-established.

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	NIRIDAZOLE
Drug class	niridazole
Modality	Small molecule
Therapeutic area	Metabolic
Phase	Phase 2

Mechanism of action

Imagine Niridazole as a disruptor of the parasite's internal machinery. By blocking key enzymes, it prevents the parasite from producing the energy it needs to survive, ultimately killing it. This targeted approach helps minimize harm to the host while effectively treating the infection.

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:

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

Frequently asked questions about Nitrothiazol

What is Nitrothiazol?

Nitrothiazol (NIRIDAZOLE) is a niridazole drug.

How does Nitrothiazol work?

Niridazole works by interfering with the metabolic processes of certain parasites, ultimately leading to their death.

What is the generic name of Nitrothiazol?

NIRIDAZOLE is the generic (nonproprietary) name of Nitrothiazol.

What drug class is Nitrothiazol in?

Nitrothiazol belongs to the niridazole class. See all niridazole drugs at /class/niridazole.

What development phase is Nitrothiazol in?

Nitrothiazol is in Phase 2.

Drug class: All niridazole drugs
Therapeutic area: All drugs in Metabolic

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