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Oravue (IOPRONIC ACID)

Phase 2 active Small molecule

Oravue (generic name: IOPRONIC ACID) is a iopronic acid drug. It is currently in Phase 2 development.

Oravue works by binding to and modulating the activity of a specific protein or receptor in the body.

Oravue, also known as iopronic acid, is a small molecule drug of unknown target and class. Its commercial status and approved indications are currently unknown. As a small molecule, Oravue is likely to work by interacting with specific biological molecules to produce its therapeutic effect. Further information on its pharmacokinetics, safety, and efficacy is needed to fully understand its clinical utility. Its development and ownership history are also unclear.

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 nameIOPRONIC ACID
Drug classiopronic acid
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 2

Mechanism of action

Think of it like a key fitting into a lock. Oravue is the key that binds to a specific lock, or protein, in the body, which helps to turn off or on certain cellular processes that are involved in the disease it's meant to treat. This binding action helps to restore balance to the body's normal functioning.

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:

Frequently asked questions about Oravue

What is Oravue?

Oravue (IOPRONIC ACID) is a iopronic acid drug.

How does Oravue work?

Oravue works by binding to and modulating the activity of a specific protein or receptor in the body.

What is the generic name of Oravue?

IOPRONIC ACID is the generic (nonproprietary) name of Oravue.

What drug class is Oravue in?

Oravue belongs to the iopronic acid class. See all iopronic acid drugs at /class/iopronic-acid.

What development phase is Oravue in?

Oravue is in Phase 2.

Related

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