Last reviewed 2026-05-22 · How we verify

P-Acetamidophenylacetic Acid (ACTARIT)

Phase 2 active Small molecule ✓ Verified May 2026

P-Acetamidophenylacetic Acid (generic name: ACTARIT) is a actarit drug. It is currently in Phase 2 development.

ACTARIT is thought to work by modulating a specific biological pathway, although the exact details of its mechanism are not well understood.

P-Acetamidophenylacetic Acid is a small molecule with various synonyms, including Actarit, Mirabegron, and others. Its exact mechanism and clinical uses are not specified in the provided information, but it is listed as a compound with a modality of small molecule.

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	ACTARIT
Drug class	actarit
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like a orchestra, and ACTARIT is like a conductor that helps the cells work together in harmony. By influencing the way cells communicate and respond to signals, ACTARIT may help to regulate various bodily functions. However, the precise way in which it does this is still a mystery.

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:

P-Acetamidophenylacetic Acid CI brief — competitive landscape report
P-Acetamidophenylacetic Acid updates RSS · CI watch RSS

Frequently asked questions about P-Acetamidophenylacetic Acid

What is P-Acetamidophenylacetic Acid?

P-Acetamidophenylacetic Acid (ACTARIT) is a actarit drug.

How does P-Acetamidophenylacetic Acid work?

ACTARIT is thought to work by modulating a specific biological pathway, although the exact details of its mechanism are not well understood.

What is the generic name of P-Acetamidophenylacetic Acid?

ACTARIT is the generic (nonproprietary) name of P-Acetamidophenylacetic Acid.

What drug class is P-Acetamidophenylacetic Acid in?

P-Acetamidophenylacetic Acid belongs to the actarit class. See all actarit drugs at /class/actarit.

What development phase is P-Acetamidophenylacetic Acid in?

P-Acetamidophenylacetic Acid is in Phase 2.

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

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