Last reviewed 2026-04-20 · How we verify

Idarac (FLOCTAFENINE)

Phase 2 active Small molecule

Idarac (generic name: FLOCTAFENINE) is a floctafenine drug. It is currently in Phase 2 development for Acute pain.

Idarac works by blocking the production of prostaglandins, which are chemical messengers that transmit pain signals to the brain.

Idarac (FLOCTAFENINE) is a small molecule drug that targets Prostaglandin G/H synthase 1, a key enzyme involved in pain signaling. It is classified as a floctafenine and is used to treat acute pain. The commercial status of Idarac is currently unknown, and it has not been approved by the FDA. Idarac works by inhibiting the production of prostaglandins, which are chemical messengers that transmit pain signals to the brain. Further information on its pharmacokinetics and safety profile is not available.

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	FLOCTAFENINE
Drug class	floctafenine
Target	Prostaglandin G/H synthase 1
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 2

Mechanism of action

Imagine your body has a messaging system that sends pain signals to your brain. Prostaglandins are like the messengers that carry these pain signals. Idarac blocks the production of these messengers, which helps to reduce pain.

Approved indications

Acute pain

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:

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

Frequently asked questions about Idarac

What is Idarac?

Idarac (FLOCTAFENINE) is a floctafenine drug, indicated for Acute pain.

How does Idarac work?

Idarac works by blocking the production of prostaglandins, which are chemical messengers that transmit pain signals to the brain.

What is Idarac used for?

Idarac is indicated for Acute pain.

What is the generic name of Idarac?

FLOCTAFENINE is the generic (nonproprietary) name of Idarac.

What drug class is Idarac in?

Idarac belongs to the floctafenine class. See all floctafenine drugs at /class/floctafenine.

What development phase is Idarac in?

Idarac is in Phase 2.

What does Idarac target?

Idarac targets Prostaglandin G/H synthase 1 and is a floctafenine.

Drug class: All floctafenine drugs
Target: All drugs targeting Prostaglandin G/H synthase 1
Therapeutic area: All drugs in Pain
Indication: Drugs for Acute pain

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