Last reviewed 2026-04-19 · How we verify

LONAZOLAC

Phase 2 active Small molecule

LONAZOLAC is a lonazolac drug. It is currently in Phase 2 development.

LONAZOLAC works by inhibiting the enzyme Prostaglandin E synthase, which plays a role in the production of prostaglandins.

LONAZOLAC is a small molecule drug that targets Prostaglandin E synthase. It belongs to the lonazolac class and its mechanism of action is not well-documented. There is limited information available on its commercial status, approved indications, and pharmacokinetic properties. Further research is needed to fully understand its clinical utility and safety profile. As a result, it is not possible to provide a comprehensive summary of LONAZOLAC at this time.

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	LONAZOLAC
Drug class	lonazolac
Target	Prostaglandin E synthase
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 2

Mechanism of action

Prostaglandins are hormone-like substances that can cause pain and inflammation. By blocking the enzyme that makes prostaglandins, LONAZOLAC may help reduce pain and inflammation. This can be beneficial for people with conditions such as arthritis or other inflammatory diseases.

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:

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

Frequently asked questions about LONAZOLAC

What is LONAZOLAC?

LONAZOLAC is a lonazolac drug.

How does LONAZOLAC work?

LONAZOLAC works by inhibiting the enzyme Prostaglandin E synthase, which plays a role in the production of prostaglandins.

What drug class is LONAZOLAC in?

LONAZOLAC belongs to the lonazolac class. See all lonazolac drugs at /class/lonazolac.

What development phase is LONAZOLAC in?

LONAZOLAC is in Phase 2.

What does LONAZOLAC target?

LONAZOLAC targets Prostaglandin E synthase and is a lonazolac.

Drug class: All lonazolac drugs
Target: All drugs targeting Prostaglandin E synthase
Therapeutic area: All drugs in Immunology

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