Last reviewed 2026-06-01 · How we verify

Fesoterodine PR

Pfizer · Phase 3 active Small molecule Under review

Fesoterodine PR is a Muscarinic M3 receptor antagonist Small molecule drug developed by Pfizer. It is currently in Phase 3 development for Overactive bladder with symptoms of urge incontinence, urgency, and frequency. Also known as: Safety extension phase.

Fesoterodine is a muscarinic M3 receptor antagonist that relaxes bladder smooth muscle to reduce urinary incontinence and overactive bladder symptoms.

Fesoterodine PR is a small molecule medication used to treat urinary bladder conditions, specifically those caused by a neurological condition. It is available in two doses, 4 mg and 8 mg, and has been compared to oxybutynin in clinical trials.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	Fesoterodine PR
Also known as	Safety extension phase
Sponsor	Pfizer
Drug class	Muscarinic M3 receptor antagonist
Target	M3 muscarinic acetylcholine receptor
Modality	Small molecule
Therapeutic area	Urology
Phase	Phase 3

Mechanism of action

Fesoterodine is a prodrug that is rapidly hydrolyzed to its active metabolite, which selectively blocks M3 muscarinic acetylcholine receptors on bladder detrusor muscle. This antagonism prevents acetylcholine-induced bladder contractions, increasing bladder capacity and reducing the urge to urinate. The extended-release (PR) formulation provides sustained drug delivery for once-daily dosing.

Approved indications

Overactive bladder with symptoms of urge incontinence, urgency, and frequency

Common side effects

Dry mouth
Constipation
Headache
Urinary tract infection
Blurred vision

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.

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:

Fesoterodine PR CI brief — competitive landscape report
Fesoterodine PR updates RSS · CI watch RSS
Pfizer portfolio CI

Frequently asked questions about Fesoterodine PR

What is Fesoterodine PR?

Fesoterodine PR is a Muscarinic M3 receptor antagonist drug developed by Pfizer, indicated for Overactive bladder with symptoms of urge incontinence, urgency, and frequency.

How does Fesoterodine PR work?

Fesoterodine is a muscarinic M3 receptor antagonist that relaxes bladder smooth muscle to reduce urinary incontinence and overactive bladder symptoms.

What is Fesoterodine PR used for?

Fesoterodine PR is indicated for Overactive bladder with symptoms of urge incontinence, urgency, and frequency.

Who makes Fesoterodine PR?

Fesoterodine PR is developed by Pfizer (see full Pfizer pipeline at /company/pfizer).

Is Fesoterodine PR also known as anything else?

Fesoterodine PR is also known as Safety extension phase.

What drug class is Fesoterodine PR in?

Fesoterodine PR belongs to the Muscarinic M3 receptor antagonist class. See all Muscarinic M3 receptor antagonist drugs at /class/muscarinic-m3-receptor-antagonist.

What development phase is Fesoterodine PR in?

Fesoterodine PR is in Phase 3.

What are the side effects of Fesoterodine PR?

Common side effects of Fesoterodine PR include Dry mouth, Constipation, Headache, Urinary tract infection, Blurred vision.

What does Fesoterodine PR target?

Fesoterodine PR targets M3 muscarinic acetylcholine receptor and is a Muscarinic M3 receptor antagonist.

Drug class: All Muscarinic M3 receptor antagonist drugs
Target: All drugs targeting M3 muscarinic acetylcholine receptor
Manufacturer: Pfizer — full pipeline
Therapeutic area: All drugs in Urology
Indication: Drugs for Overactive bladder with symptoms of urge incontinence, urgency, and frequency
Also known as: Safety extension phase

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