Last reviewed 2026-05-30 · How we verify

Urine and stoll samples

Assistance Publique - Hôpitaux de Paris · Phase 2 active Biologic ✓ Verified May 2026

Urine and stoll samples is a Biologic drug developed by Assistance Publique - Hôpitaux de Paris. It is currently in Phase 2 development.

Researchers are studying urine and stool samples as part of a clinical trial to investigate their potential as inflammatory markers in chronic inflammatory bowel disease. The trial specifically focuses on the urinary prostaglandin E-major urinary metabolite (PGE-MUM) as a potential marker for this condition.

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	Urine and stoll samples
Sponsor	Assistance Publique - Hôpitaux de Paris
Modality	Biologic
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Urinary PGE-MUM (PROSTAGLANDIN E-MAJOR URINARY METABOLITE) as Inflammatory Marker in Chronic Inflammatory Bowel Disease

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:

Urine and stoll samples CI brief — competitive landscape report
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Frequently asked questions about Urine and stoll samples

What is Urine and stoll samples?

Urine and stoll samples is a Biologic drug developed by Assistance Publique - Hôpitaux de Paris.

Who makes Urine and stoll samples?

Urine and stoll samples is developed by Assistance Publique - Hôpitaux de Paris (see full Assistance Publique - Hôpitaux de Paris pipeline at /company/assistance-publique-h-pitaux-de-paris).

What development phase is Urine and stoll samples in?

Urine and stoll samples is in Phase 2.

Manufacturer: Assistance Publique - Hôpitaux de Paris — full pipeline

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