Last reviewed 2026-05-15 · How we verify

PF-06865571 Monotherapy

Pfizer · Phase 2 active Small molecule

PF-06865571 Monotherapy is a Small molecule drug developed by Pfizer. It is currently in Phase 2 development. Also known as: Arm C.

Likelihood of approval

18.3% 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).
Big-pharma sponsor +3.0pp
Pfizer 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	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	PF-06865571 Monotherapy
Also known as	Arm C
Sponsor	Pfizer
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease. (PHASE2)

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:

PF-06865571 Monotherapy CI brief — competitive landscape report
PF-06865571 Monotherapy updates RSS · CI watch RSS
Pfizer portfolio CI

Frequently asked questions about PF-06865571 Monotherapy

What is PF-06865571 Monotherapy?

PF-06865571 Monotherapy is a Small molecule drug developed by Pfizer.

Who makes PF-06865571 Monotherapy?

PF-06865571 Monotherapy is developed by Pfizer (see full Pfizer pipeline at /company/pfizer).

Is PF-06865571 Monotherapy also known as anything else?

PF-06865571 Monotherapy is also known as Arm C.

What development phase is PF-06865571 Monotherapy in?

PF-06865571 Monotherapy is in Phase 2.

Manufacturer: Pfizer — full pipeline
Also known as: Arm C

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