Last reviewed · How we verify
GABEXATE
GABEXATE is a gabexate drug. It is currently in Phase 3 development.
GABEXATE works by inhibiting the activity of tryptase enzymes.
GABEXATE is a small molecule drug in the gabexate class, targeting tryptase alpha/beta-1. It is not FDA-approved, and its commercial status is unknown. GABEXATE is used to treat conditions associated with excessive tryptase activity, although specific indications are not well-documented. As a gabexate, it is believed to inhibit the activity of tryptase enzymes, which play a role in various physiological and pathological processes. Further research is needed to fully understand its clinical applications and safety profile.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 name | GABEXATE |
|---|---|
| Drug class | gabexate |
| Target | Coagulation factor XII, Multidrug and toxin extrusion protein 1, Multidrug and toxin extrusion protein 2 |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
Think of tryptase enzymes like scissors that cut through proteins. When these enzymes are overactive, they can cause problems in the body. GABEXATE acts like a brake, slowing down the scissors so they don't cut too much.
Approved indications
Common side effects
Key clinical trials
- Conduction System Pacing vs Biventricular Pacing in Systolic Dysfunction and Wide QRS: Mortality, Heart Failure Hospitalization or Cardiac Transplant (NA)
- Effects of Cannabidiol on Burnout Syndrome and Empathy of Caregivers of Older Adults (EARLY_PHASE1)
- A Library-based Prevention Intervention for Adolescents Affected by Parental Drug Use (NA)
- Evaluation of Respecting the Circle of Life on Pregnancy Prevention Outcomes Among American Indian Adolescents (NA)
- Dexmedetomidine Versus Sevoflurane in Children With Anticipated Difficult Intubation (PHASE2)
- Air-Q® SP Versus Williams Intubating Airway for Single-Operator FOI (NA)
- Evaluation of the Effect of Gabexate Mesilate in the Hepatocyte Protection After Liver Resection (PHASE3)
- Comparison of Various Supraglottic Airway Devices for Fiberoptical Guided Tracheal Intubation (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- GABEXATE CI brief — competitive landscape report
- GABEXATE updates RSS · CI watch RSS
Frequently asked questions about GABEXATE
What is GABEXATE?
How does GABEXATE work?
What drug class is GABEXATE in?
What development phase is GABEXATE in?
What does GABEXATE target?
Related
- Drug class: All gabexate drugs
- Target: All drugs targeting Coagulation factor XII, Multidrug and toxin extrusion protein 1, Multidrug and toxin extrusion protein 2
- Therapeutic area: All drugs in Hematology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing