Last reviewed 2026-04-20 · How we verify

Uridion (ISOBROMINDIONE)

Phase 2 active Small molecule

Uridion (generic name: ISOBROMINDIONE) is a isobromindione drug. It is currently in Phase 2 development.

Uridion works by interacting with a specific target in the body to produce a therapeutic effect.

Uridion (isobromindione) is a small molecule drug in the isobromindione class, but information on its target and mechanism of action is not available. Its commercial status and approved indications are also unknown. As a result, there is limited information available on its safety profile and pharmacokinetic properties. Further research is needed to fully understand the characteristics of Uridion. Its development and ownership history are also unclear.

Likelihood of approval

12.3% 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).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

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	ISOBROMINDIONE
Drug class	isobromindione
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Unfortunately, the exact mechanism of action of Uridion is not well understood, but it is thought to involve a complex interaction with a specific protein or receptor in the body. This interaction is believed to produce a therapeutic effect, but the details of how it works are not yet clear. More research is needed to fully understand how Uridion produces its effects.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Uridion CI brief — competitive landscape report
Uridion updates RSS · CI watch RSS

Frequently asked questions about Uridion

What is Uridion?

Uridion (ISOBROMINDIONE) is a isobromindione drug.

How does Uridion work?

Uridion works by interacting with a specific target in the body to produce a therapeutic effect.

What is the generic name of Uridion?

ISOBROMINDIONE is the generic (nonproprietary) name of Uridion.

What drug class is Uridion in?

Uridion belongs to the isobromindione class. See all isobromindione drugs at /class/isobromindione.

What development phase is Uridion in?

Uridion is in Phase 2.

Drug class: All isobromindione drugs
Therapeutic area: All drugs in Neuroscience

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