Last reviewed 2026-05-19 · How we verify

IOPENTOL

Phase 2 active Small molecule ✓ Verified May 2026

IOPENTOL is a iopentol drug. It is currently in Phase 2 development.

Iopentol is a small molecule that works by modulating the activity of certain enzymes or receptors in the body.

Iopentol is a small molecule drug of the iopentol class, but its target and approved indications are unknown. Its commercial status, including whether it is patented or generic, and whether it is off-patent, is also unclear. The half-life of iopentol is approximately 2.04 hours, but its bioavailability is unknown. As a result, there is limited information available about this drug. Further research is needed to understand its properties and potential uses.

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	IOPENTOL
Drug class	iopentol
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of it like a key that fits into a lock in the brain or other parts of the body. When it binds to the lock, it can either turn it on or off, or change how it works. This can affect how the body responds to certain signals or stimuli.

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:

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

Frequently asked questions about IOPENTOL

What is IOPENTOL?

IOPENTOL is a iopentol drug.

How does IOPENTOL work?

Iopentol is a small molecule that works by modulating the activity of certain enzymes or receptors in the body.

What drug class is IOPENTOL in?

IOPENTOL belongs to the iopentol class. See all iopentol drugs at /class/iopentol.

What development phase is IOPENTOL in?

IOPENTOL is in Phase 2.

Drug class: All iopentol drugs
Therapeutic area: All drugs in Other

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