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Rivoroxaban
Rivoroxaban is a Small molecule drug developed by Foundation University Islamabad. It is currently in Phase 3 development.
Rivoroxaban is a medication used to treat conditions such as valvular heart disease and cerebral venous thrombosis. It has been compared to warfarin in clinical trials, including a study at the Rawalpindi Institute of Cardiology comparing its use in patients with mechanical heart valves.
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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 | Rivoroxaban |
|---|---|
| Sponsor | Foundation University Islamabad |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Rivaroxaban vs Warfarin in Patients With Mechanical Heart Valves (PHASE3)
- Efficacy Comparison of Warfarin Versus Rivaroxaban CVT (PHASE1, PHASE2)
- Comparison of the Efficacy of Rivroxaban to Coumadin( Warfarin ) in Cerebral Venous Thrombosis (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:
- Rivoroxaban CI brief — competitive landscape report
- Rivoroxaban updates RSS · CI watch RSS
- Foundation University Islamabad portfolio CI
Frequently asked questions about Rivoroxaban
What is Rivoroxaban?
Who makes Rivoroxaban?
What development phase is Rivoroxaban in?
Related
- Manufacturer: Foundation University Islamabad — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing