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Tensigradyl (GUABENXAN)

Phase 2 active Small molecule

Tensigradyl (generic name: GUABENXAN) is a guabenxan drug. It is currently in Phase 2 development.

Tensigradyl works by binding to specific biological molecules to produce a therapeutic effect.

Tensigradyl (GUABENXAN) is a small molecule drug in the guabenxan class, but specific details about its target and mechanism of action are unknown. Its commercial status and approved indications are also unclear. As a small molecule, it is likely to work by interacting with specific biological molecules to produce a therapeutic effect. Further information about its pharmacokinetic properties, such as half-life and bioavailability, is not available. The current owner and generic manufacturers of Tensigradyl are also unknown.

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 nameGUABENXAN
Drug classguabenxan
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 2

Mechanism of action

Imagine your body's cells are like a city, and Tensigradyl is a key that unlocks a specific door to allow the right things to happen. By binding to these molecules, Tensigradyl helps to restore balance and normal function to the cells, which can help to treat various diseases.

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 Tensigradyl

What is Tensigradyl?

Tensigradyl (GUABENXAN) is a guabenxan drug.

How does Tensigradyl work?

Tensigradyl works by binding to specific biological molecules to produce a therapeutic effect.

What is the generic name of Tensigradyl?

GUABENXAN is the generic (nonproprietary) name of Tensigradyl.

What drug class is Tensigradyl in?

Tensigradyl belongs to the guabenxan class. See all guabenxan drugs at /class/guabenxan.

What development phase is Tensigradyl in?

Tensigradyl is in Phase 2.

Related

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