Last reviewed 2026-04-20 · How we verify

Formiloxin (GITOFORMATE)

Phase 2 active Small molecule

Formiloxin (generic name: GITOFORMATE) is a gitoformate drug. It is currently in Phase 2 development.

Formiloxin is thought to work by interacting with a specific molecular target to produce a therapeutic effect.

Formiloxin, also known as GITOFORMATE, is a small molecule drug in the gitoformate class. Its exact target and mechanism of action are unknown, but it is being developed for potential therapeutic applications. The commercial status of Formiloxin is unclear, with no information available on FDA approval, patent status, or generic manufacturers. Further research is needed to determine its efficacy and safety profile. As a result, key safety considerations and approved indications are currently unknown.

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	GITOFORMATE
Drug class	gitoformate
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and the key to unlocking these locks is a specific molecule. Formiloxin is designed to be that key, but the exact lock it fits into is still unknown. By binding to this target, Formiloxin may help to regulate various cellular processes and produce a therapeutic effect.

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:

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

Frequently asked questions about Formiloxin

What is Formiloxin?

Formiloxin (GITOFORMATE) is a gitoformate drug.

How does Formiloxin work?

Formiloxin is thought to work by interacting with a specific molecular target to produce a therapeutic effect.

What is the generic name of Formiloxin?

GITOFORMATE is the generic (nonproprietary) name of Formiloxin.

What drug class is Formiloxin in?

Formiloxin belongs to the gitoformate class. See all gitoformate drugs at /class/gitoformate.

What development phase is Formiloxin in?

Formiloxin is in Phase 2.

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

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