Last reviewed 2026-04-20 · How we verify

Dibromannit (MITOBRONITOL)

Phase 2 active Small molecule

Dibromannit (generic name: MITOBRONITOL) is a mitobronitol drug. It is currently in Phase 2 development.

Dibromannitol is thought to work by inhibiting cellular respiration, specifically targeting the electron transport chain.

Dibromannitol, also known as mitobronitol, is a small molecule drug of the mitobronitol class. Its original development is unclear, and its current owner is also unknown. The target of dibromannitol is not specified, and it has not been approved by the FDA for any indications. The commercial status of dibromannitol, including whether it is patented or generic, is also unknown. As a result, key safety considerations and pharmacological details are not well-documented.

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	MITOBRONITOL
Drug class	mitobronitol
Modality	Small molecule
Therapeutic area	Respiratory
Phase	Phase 2

Mechanism of action

Imagine your cells are like power plants, generating energy for your body. Dibromannitol is like a brake on the power plant's engine, slowing down the production of energy. This can be useful in certain medical conditions, but it also means the drug can have significant side effects.

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:

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

Frequently asked questions about Dibromannit

What is Dibromannit?

Dibromannit (MITOBRONITOL) is a mitobronitol drug.

How does Dibromannit work?

Dibromannitol is thought to work by inhibiting cellular respiration, specifically targeting the electron transport chain.

What is the generic name of Dibromannit?

MITOBRONITOL is the generic (nonproprietary) name of Dibromannit.

What drug class is Dibromannit in?

Dibromannit belongs to the mitobronitol class. See all mitobronitol drugs at /class/mitobronitol.

What development phase is Dibromannit in?

Dibromannit is in Phase 2.

Drug class: All mitobronitol drugs
Therapeutic area: All drugs in Respiratory

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