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Cyclovegantine (DROFENINE)

Phase 2 active Small molecule

Cyclovegantine (generic name: DROFENINE) is a drug. It is currently in Phase 2 development.

Cyclovexgantine works by binding to specific proteins or receptors in the body to produce a therapeutic effect.

Cyclovexgantine, also known as DROFENINE, is a small molecule drug with unknown target and drug class. Its commercial status is unclear, and it is not known if it is FDA approved or off-patent. The approved indications for Cyclovexgantine are also unknown. As a small molecule, it is likely to work by interacting with specific biological molecules to produce a therapeutic effect. Further research is needed to fully understand its mechanism of action and safety profile.

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 nameDROFENINE
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 2

Mechanism of action

Imagine your body's cells are like locks, and Cyclovexgantine is a key that fits into those locks. When it binds to the right lock, it can help to turn off or turn on certain cellular processes that are involved in the disease it's being used to treat. This can help 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 Cyclovegantine

What is Cyclovegantine?

Cyclovegantine (DROFENINE) is a Small molecule drug.

How does Cyclovegantine work?

Cyclovexgantine works by binding to specific proteins or receptors in the body to produce a therapeutic effect.

What is the generic name of Cyclovegantine?

DROFENINE is the generic (nonproprietary) name of Cyclovegantine.

What development phase is Cyclovegantine in?

Cyclovegantine is in Phase 2.

Related

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