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Orafang Tab
Orafang Tab is a Direct Factor Xa inhibitor Small molecule drug developed by Taejoon Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Thromboembolism prevention (specific indication under Phase 3 evaluation).
Orafang is an oral anticoagulant that inhibits Factor Xa in the coagulation cascade to prevent thrombus formation.
Orafang is an oral anticoagulant that inhibits Factor Xa in the coagulation cascade to prevent thrombus formation. Used for Thromboembolism prevention (specific indication under Phase 3 evaluation).
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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). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| 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 | Orafang Tab |
|---|---|
| Sponsor | Taejoon Pharmaceutical Co., Ltd. |
| Drug class | Direct Factor Xa inhibitor |
| Target | Factor Xa |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Orafang directly inhibits Factor Xa, a key serine protease in the intrinsic and common pathways of blood coagulation. By blocking Factor Xa activity, the drug reduces thrombin generation and subsequent fibrin clot formation, thereby preventing thrombotic events. This mechanism is characteristic of direct Factor Xa inhibitors used in anticoagulation therapy.
Approved indications
- Thromboembolism prevention (specific indication under Phase 3 evaluation)
Common side effects
- Bleeding
- Gastrointestinal disturbance
Key clinical trials
- A Study to Evaluate the Safety and Effectiveness of MSP01-T for Bowel Cleansing Before a Colonoscopy (PHASE3)
- Efficacy and Safety of DWJ1609 for Bowel Cleansing Before Colonoscopy; (PHASE3)
- A Prospective, Randomized, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial (PHASE3)
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:
- Orafang Tab CI brief — competitive landscape report
- Orafang Tab updates RSS · CI watch RSS
- Taejoon Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about Orafang Tab
What is Orafang Tab?
How does Orafang Tab work?
What is Orafang Tab used for?
Who makes Orafang Tab?
What drug class is Orafang Tab in?
What development phase is Orafang Tab in?
What are the side effects of Orafang Tab?
What does Orafang Tab target?
Related
- Drug class: All Direct Factor Xa inhibitor drugs
- Target: All drugs targeting Factor Xa
- Manufacturer: Taejoon Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Thromboembolism prevention (specific indication under Phase 3 evaluation)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing