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danaparoid
danaparoid is a Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 2 development.
Danaparoid sodium is an anticoagulant that activates Antithrombin-III, which in turn inhibits thrombin generation by indirectly inactivating Factor Xa and directly inhibiting thrombin activation of Factor IX. It has been studied as a treatment for conditions such as Heparin-induced Thrombocytopenia, Ischemic Stroke, and Stroke, among others.
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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). -
Big-pharma sponsor
+3.0pp
GlaxoSmithKline is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 name | danaparoid |
|---|---|
| Sponsor | GlaxoSmithKline |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Multicentric Prospective Validation of a Universal Test to Quantify Apixaban, Rivaroxaban, Danaparoid and Fondaparinux Levels
- Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study Safety and Efficacy of Danaparoid vs Argatroban (PHASE3)
- Multicenter Study on Dialysis Modalities for End-stage Chronic Renal Failure Patients With Heparin-induced Thrombocytopenia (NA)
- Characterization of Retinal Microvascular and FAZ Changes in Ischemic Stroke and Its Different Types
- Vitamin D and Stroke
- Retrospective Registry of Patients With Acute Heparin-induced Thrombocytopenia Type II
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:
- danaparoid CI brief — competitive landscape report
- danaparoid updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about danaparoid
What is danaparoid?
Who makes danaparoid?
What development phase is danaparoid in?
Related
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing