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Cycvalon (CYCLOVALONE)

Phase 2 active Small molecule

Cycvalon (generic name: CYCLOVALONE) is a cyclovalone drug. It is currently in Phase 2 development.

Cycvalon works by blocking the NF-kappa-B pathway, which helps regulate inflammation and immune responses.

Cycvalon, also known as cyclovalone, is a small molecule modality targeting the nuclear factor NF-kappa-B p105 subunit. It is currently owned by an unknown entity, and its commercial status is unclear. Cycvalon is being developed to treat various conditions, but its specific indications and approval status are not publicly disclosed. As a small molecule, cycvalon works by inhibiting the NF-kappa-B pathway, which plays a crucial role in inflammation and immune responses. Further information on its pharmacokinetics and safety profile is not available.

Likelihood of approval
16.3% 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).
  • Immunology slight uplift +1.0pp
    Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
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 nameCYCLOVALONE
Drug classcyclovalone
TargetTranscription factor AP-1, Nuclear factor NF-kappa-B p105 subunit, Integrase
ModalitySmall molecule
Therapeutic areaImmunology
PhasePhase 2

Mechanism of action

Think of NF-kappa-B like a master switch that controls how our body responds to injury or infection. When this switch is turned on, it can lead to inflammation and other immune responses. Cycvalon works by blocking this switch, which can help reduce inflammation and other symptoms associated with certain conditions.

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 Cycvalon

What is Cycvalon?

Cycvalon (CYCLOVALONE) is a cyclovalone drug.

How does Cycvalon work?

Cycvalon works by blocking the NF-kappa-B pathway, which helps regulate inflammation and immune responses.

What is the generic name of Cycvalon?

CYCLOVALONE is the generic (nonproprietary) name of Cycvalon.

What drug class is Cycvalon in?

Cycvalon belongs to the cyclovalone class. See all cyclovalone drugs at /class/cyclovalone.

What development phase is Cycvalon in?

Cycvalon is in Phase 2.

What does Cycvalon target?

Cycvalon targets Transcription factor AP-1, Nuclear factor NF-kappa-B p105 subunit, Integrase and is a cyclovalone.

Related

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