Last reviewed 2026-06-03 · How we verify

LOBENZARIT

Phase 2 active Small molecule ✓ Verified Jun 2026 Quality 19/100

LOBENZARIT is a lobenzarit drug. It is currently in Phase 2 development.

LOBENZARIT works by inhibiting a specific enzyme or pathway, although the exact details are not publicly available.

LOBENZARIT is a small molecule used in the treatment of Rheumatoid Arthritis (RA). It is being studied in combination with disease-modifying antirheumatic drugs (DMARDs) as part of a clinical trial to assess its safety and efficacy.

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	LOBENZARIT
Drug class	lobenzarit
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have a factory inside them that produces certain chemicals. LOBENZARIT is designed to block or slow down this factory, which can help treat certain conditions. However, more research is needed to understand how it works and what effects it has on the body.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study to Assess Safety and Efficacy of ASP015K in Participants With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX) (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

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

Frequently asked questions about LOBENZARIT

What is LOBENZARIT?

LOBENZARIT is a lobenzarit drug.

How does LOBENZARIT work?

LOBENZARIT works by inhibiting a specific enzyme or pathway, although the exact details are not publicly available.

What drug class is LOBENZARIT in?

LOBENZARIT belongs to the lobenzarit class. See all lobenzarit drugs at /class/lobenzarit.

What development phase is LOBENZARIT in?

LOBENZARIT is in Phase 2.

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

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