Last reviewed 2026-05-22 · How we verify

Ursonorm

Sheffield Teaching Hospitals NHS Foundation Trust · Phase 2 active Small molecule ✓ Verified May 2026

Ursonorm is a Small molecule drug developed by Sheffield Teaching Hospitals NHS Foundation Trust. It is currently in Phase 2 development. Also known as: UDCA.

Ursonorm is a small molecule agonist that targets the bile acid receptor, specifically acting as a FXR agonist. It is being studied in a clinical trial for the treatment of Parkinson's Disease.

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	Ursonorm
Also known as	UDCA
Sponsor	Sheffield Teaching Hospitals NHS Foundation Trust
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Trial of Ursodeoxycholic Acid (UDCA) for Parkinson's Disease: The "UP" Study (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:

Ursonorm CI brief — competitive landscape report
Ursonorm updates RSS · CI watch RSS
Sheffield Teaching Hospitals NHS Foundation Trust portfolio CI

Frequently asked questions about Ursonorm

What is Ursonorm?

Ursonorm is a Small molecule drug developed by Sheffield Teaching Hospitals NHS Foundation Trust.

Who makes Ursonorm?

Ursonorm is developed by Sheffield Teaching Hospitals NHS Foundation Trust (see full Sheffield Teaching Hospitals NHS Foundation Trust pipeline at /company/sheffield-teaching-hospitals-nhs-foundation-trust).

Is Ursonorm also known as anything else?

Ursonorm is also known as UDCA.

What development phase is Ursonorm in?

Ursonorm is in Phase 2.

Manufacturer: Sheffield Teaching Hospitals NHS Foundation Trust — full pipeline
Therapeutic area: All drugs in Other
Also known as: UDCA

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