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ISIS-FXIRx Dose #2
ISIS-FXIRx Dose #2 is a Antisense oligonucleotide anticoagulant Small molecule drug developed by Ionis Pharmaceuticals, Inc.. It is currently in Phase 2 development. Also known as: ISIS-FXIRx.
Antisense oligonucleotide that reduces production of factor XI, a clotting protein, to prevent thrombosis while minimizing bleeding risk.
ISIS-FXIRx Dose #2 is being studied in a clinical trial for its potential to treat End-stage Renal Disease (ESRD) and Venous Thromboembolism. The trial, NCT03358030, is evaluating the efficacy of ISIS 416858, a treatment that includes ISIS-FXIRx Dose #2, compared to a placebo.
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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).
| 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 | ISIS-FXIRx Dose #2 |
|---|---|
| Also known as | ISIS-FXIRx |
| Sponsor | Ionis Pharmaceuticals, Inc. |
| Drug class | Antisense oligonucleotide anticoagulant |
| Modality | Small molecule |
| Phase | Phase 2 |
Mechanism of action
ISIS-FXIRx uses antisense technology to bind to FXI messenger RNA, reducing the synthesis of factor XI protein in the liver. By lowering FXI levels, the drug inhibits the intrinsic coagulation pathway, providing anticoagulation with potentially lower bleeding risk than traditional anticoagulants that target other clotting factors.
Approved indications
Common side effects
Key clinical trials
- A Study of ISIS 416858 Administered Subcutaneously to Participants With End-Stage Renal Disease (ESRD) on Hemodialysis (PHASE2)
- Active Comparator-Controlled Study to Assess Safety and Efficacy of ISIS-FXIRx in Total Knee Arthroplasty (PHASE2)
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:
- ISIS-FXIRx Dose #2 CI brief — competitive landscape report
- ISIS-FXIRx Dose #2 updates RSS · CI watch RSS
- Ionis Pharmaceuticals, Inc. portfolio CI
Frequently asked questions about ISIS-FXIRx Dose #2
What is ISIS-FXIRx Dose #2?
How does ISIS-FXIRx Dose #2 work?
Who makes ISIS-FXIRx Dose #2?
Is ISIS-FXIRx Dose #2 also known as anything else?
What drug class is ISIS-FXIRx Dose #2 in?
What development phase is ISIS-FXIRx Dose #2 in?
Related
- Drug class: All Antisense oligonucleotide anticoagulant drugs
- Manufacturer: Ionis Pharmaceuticals, Inc. — full pipeline
- Also known as: ISIS-FXIRx
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing