Last reviewed 2026-06-02 · How we verify

Nitromidine (AZANIDAZOLE)

Phase 2 active Small molecule

Nitromidine (generic name: AZANIDAZOLE) is a azanidazole drug. It is currently in Phase 2 development.

Nitromidine works by targeting an unknown mechanism to produce its therapeutic effects.

Nitromidine, also known as azanidazole, is a small molecule drug of the azanidazole class. Its target and exact mechanism of action are unknown, but it is being developed for potential therapeutic applications. The commercial status of nitromidine is unclear, and it has not been approved by the FDA for any indications. Further research is needed to determine its efficacy and safety profile. As a result, key safety considerations and approved indications are currently unavailable.

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	AZANIDAZOLE
Drug class	azanidazole
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have a specific lock that needs to be opened to allow the right things in and out. Nitromidine is like a key that fits into this lock, but we don't know exactly how it works yet. This is a simplified explanation, and the actual mechanism is likely to be much more complex.

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:

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

Frequently asked questions about Nitromidine

What is Nitromidine?

Nitromidine (AZANIDAZOLE) is a azanidazole drug.

How does Nitromidine work?

Nitromidine works by targeting an unknown mechanism to produce its therapeutic effects.

What is the generic name of Nitromidine?

AZANIDAZOLE is the generic (nonproprietary) name of Nitromidine.

What drug class is Nitromidine in?

Nitromidine belongs to the azanidazole class. See all azanidazole drugs at /class/azanidazole.

What development phase is Nitromidine in?

Nitromidine is in Phase 2.

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

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