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Phenthiourezine (AMOCARZINE)

Phase 2 active Small molecule

Phenthiourezine (generic name: AMOCARZINE) is a drug. It is currently in Phase 2 development.

Phenthiourezine is a small molecule that works by interacting with a specific biological target to produce a therapeutic effect.

Phenthiourezine, also known as AMOCARZINE, is a small molecule drug with unknown target and drug class. Its commercial status is unclear, and it has not been approved by the FDA for any indications. As a result, there is limited information available on its pharmacokinetic properties, such as half-life and bioavailability. Further research is needed to determine its potential therapeutic applications and safety profile. The lack of approved indications and patent status makes it difficult to assess its commercial viability.

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 nameAMOCARZINE
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 2

Mechanism of action

Imagine your body's cells have locks on them, and Phenthiourezine is a key that fits into one of those locks. When it binds to the lock, it sends a signal that helps to regulate various cellular processes, leading to a therapeutic effect. However, the exact lock and signal pathway are unknown for Phenthiourezine, making it difficult to understand how it works.

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 Phenthiourezine

What is Phenthiourezine?

Phenthiourezine (AMOCARZINE) is a Small molecule drug.

How does Phenthiourezine work?

Phenthiourezine is a small molecule that works by interacting with a specific biological target to produce a therapeutic effect.

What is the generic name of Phenthiourezine?

AMOCARZINE is the generic (nonproprietary) name of Phenthiourezine.

What development phase is Phenthiourezine in?

Phenthiourezine is in Phase 2.

Related

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