Last reviewed 2026-05-31 · How we verify

Sofenac (ISOFEZOLAC)

Phase 2 active Small molecule ✓ Verified May 2026

Sofenac (generic name: ISOFEZOLAC) is a isofezolac drug. It is currently in Phase 2 development for Osteoarthritis, Rheumatoid arthritis.

Sofenac works by inhibiting the COX-2 enzyme, which reduces inflammation and pain.

Sofenac (ISOFEZOLAC) is a small molecule drug in the isofezolac class, used to treat Osteoarthritis and Rheumatoid arthritis. Its exact target is unknown, but it is believed to work by inhibiting the enzyme COX-2, which plays a key role in inflammation. Sofenac is not FDA approved, and its commercial status is unclear. Key safety considerations include potential gastrointestinal side effects and cardiovascular risks. Further research is needed to fully understand its pharmacokinetics and safety profile.

Likelihood of approval

16.3% 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).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

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	ISOFEZOLAC
Drug class	isofezolac
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 2

Mechanism of action

When you have an injury or inflammation, your body produces chemicals called prostaglandins, which cause pain and swelling. Sofenac blocks the COX-2 enzyme, which is responsible for making these prostaglandins. By blocking this enzyme, Sofenac reduces the amount of prostaglandins produced, which in turn reduces pain and inflammation.

Approved indications

Osteoarthritis
Rheumatoid arthritis

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:

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

Frequently asked questions about Sofenac

What is Sofenac?

Sofenac (ISOFEZOLAC) is a isofezolac drug, indicated for Osteoarthritis, Rheumatoid arthritis.

How does Sofenac work?

Sofenac works by inhibiting the COX-2 enzyme, which reduces inflammation and pain.

What is Sofenac used for?

Sofenac is indicated for Osteoarthritis, Rheumatoid arthritis.

What is the generic name of Sofenac?

ISOFEZOLAC is the generic (nonproprietary) name of Sofenac.

What drug class is Sofenac in?

Sofenac belongs to the isofezolac class. See all isofezolac drugs at /class/isofezolac.

What development phase is Sofenac in?

Sofenac is in Phase 2.

Drug class: All isofezolac drugs
Therapeutic area: All drugs in Immunology
Indication: Drugs for Osteoarthritis
Indication: Drugs for Rheumatoid arthritis

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