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Etrasimod Immediate Release (IR) (etrasimod-immediate-release-ir)

Pfizer Inc. · Phase 1 active ✓ Verified Jun 2026 Quality 15/100

Etrasimod Immediate Release (IR) (generic name: etrasimod-immediate-release-ir) is a drug developed by Pfizer Inc.. It is currently in Phase 1 development.

Etrasimod Immediate Release (IR) is being studied in a clinical trial involving healthy participants. The purpose of this study is to evaluate the use of wearable sensors with the study medication (etrasmiod) in healthy participants.

Likelihood of approval
12.6% vs 9.6% industry baseline
If approved by FDA: likely 2033–2036
Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 1 → approval rate +9.6pp
    Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Big-pharma sponsor +3.0pp
    Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2033–2036
EMA EU 2034–2037 +0.7 yr
MHRA GB 2034–2037 +0.7 yr
Health Canada CA 2034–2038 +0.9 yr
TGA AU 2034–2038 +1.2 yr
PMDA JP 2034–2038 +1.5 yr
NMPA CN 2035–2039 +2.3 yr
MFDS KR 2034–2038 +1.4 yr
CDSCO IN 2034–2039 +1.8 yr
ANVISA BR 2035–2039 +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 nameetrasimod-immediate-release-ir
SponsorPfizer Inc.
PhasePhase 1

Approved indications

No approved indications tracked.

Common side effects

Key clinical trials

Primary sources

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

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Etrasimod Immediate Release (IR)

What is Etrasimod Immediate Release (IR)?

Etrasimod Immediate Release (IR) (etrasimod-immediate-release-ir) is a pharmaceutical drug developed by Pfizer Inc..

Who makes Etrasimod Immediate Release (IR)?

Etrasimod Immediate Release (IR) is developed by Pfizer Inc. (see full Pfizer Inc. pipeline at /company/pfizer).

What is the generic name of Etrasimod Immediate Release (IR)?

etrasimod-immediate-release-ir is the generic (nonproprietary) name of Etrasimod Immediate Release (IR).

What development phase is Etrasimod Immediate Release (IR) in?

Etrasimod Immediate Release (IR) is in Phase 1.

What are the side effects of Etrasimod Immediate Release (IR)?

Common side effects of Etrasimod Immediate Release (IR) include Application site irritation, Atrioventricular block first degree, Vessel puncture site haematoma, Lip dry, Puncture site erythema, Headache.

Related

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