Last reviewed 2026-04-20 · How we verify

Oxiflavil (EFLOXATE)

Phase 2 active Small molecule

Oxiflavil (generic name: EFLOXATE) is a efloxate drug. It is currently in Phase 2 development.

Efloxate is believed to work by inhibiting a specific enzyme or pathway.

Oxiflavil, also known as Efloxate, is a small molecule drug in the efloxate class. Its exact target and mechanism of action are unknown, but it is believed to work by inhibiting a specific enzyme or pathway. Efloxate is not FDA-approved for any indications, and its commercial status, including patent and generic availability, is unclear. Further research is needed to determine its safety and efficacy. 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	EFLOXATE
Drug class	efloxate
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of Efloxate like a key that unlocks a specific process in the body. By blocking this process, Efloxate can help to reduce symptoms or treat certain conditions. However, the exact details of how Efloxate works are still not fully understood.

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:

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

Frequently asked questions about Oxiflavil

What is Oxiflavil?

Oxiflavil (EFLOXATE) is a efloxate drug.

How does Oxiflavil work?

Efloxate is believed to work by inhibiting a specific enzyme or pathway.

What is the generic name of Oxiflavil?

EFLOXATE is the generic (nonproprietary) name of Oxiflavil.

What drug class is Oxiflavil in?

Oxiflavil belongs to the efloxate class. See all efloxate drugs at /class/efloxate.

What development phase is Oxiflavil in?

Oxiflavil is in Phase 2.

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

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