Last reviewed 2026-05-23 · How we verify

Sefaxersen (RO7434656)

Hoffmann-La Roche · Phase 3 active Small molecule Under review

Sefaxersen (RO7434656) is a Factor Xa inhibitor Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 3 development for Treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE). Also known as: Sefaxersen.

Sefaxersen is a direct Factor Xa inhibitor.

Sefaxersen (RO7434656) is an oligonucleotide being studied for its efficacy and safety in treating Primary IgA Nephropathy. It is being investigated in a clinical trial (NCT05797610) as a potential treatment for this condition.

Likelihood of approval

59.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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.
Big-pharma sponsor +3.0pp
Hoffmann-La Roche is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Sefaxersen (RO7434656)
Also known as	Sefaxersen
Sponsor	Hoffmann-La Roche
Drug class	Factor Xa inhibitor
Target	Factor Xa
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 3

Mechanism of action

It works by directly inhibiting Factor Xa, a key enzyme in the coagulation cascade, thereby preventing the formation of blood clots.

Approved indications

Treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE)

Common side effects

Major bleeding
Gastrointestinal bleeding
Hemorrhage

Key clinical trials

A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression (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:

Sefaxersen (RO7434656) CI brief — competitive landscape report
Sefaxersen (RO7434656) updates RSS · CI watch RSS
Hoffmann-La Roche portfolio CI

Frequently asked questions about Sefaxersen (RO7434656)

What is Sefaxersen (RO7434656)?

Sefaxersen (RO7434656) is a Factor Xa inhibitor drug developed by Hoffmann-La Roche, indicated for Treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).

How does Sefaxersen (RO7434656) work?

Sefaxersen is a direct Factor Xa inhibitor.

What is Sefaxersen (RO7434656) used for?

Sefaxersen (RO7434656) is indicated for Treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).

Who makes Sefaxersen (RO7434656)?

Sefaxersen (RO7434656) is developed by Hoffmann-La Roche (see full Hoffmann-La Roche pipeline at /company/roche).

Is Sefaxersen (RO7434656) also known as anything else?

Sefaxersen (RO7434656) is also known as Sefaxersen.

What drug class is Sefaxersen (RO7434656) in?

Sefaxersen (RO7434656) belongs to the Factor Xa inhibitor class. See all Factor Xa inhibitor drugs at /class/factor-xa-inhibitor.

What development phase is Sefaxersen (RO7434656) in?

Sefaxersen (RO7434656) is in Phase 3.

What are the side effects of Sefaxersen (RO7434656)?

Common side effects of Sefaxersen (RO7434656) include Major bleeding, Gastrointestinal bleeding, Hemorrhage.

What does Sefaxersen (RO7434656) target?

Sefaxersen (RO7434656) targets Factor Xa and is a Factor Xa inhibitor.

Drug class: All Factor Xa inhibitor drugs
Target: All drugs targeting Factor Xa
Manufacturer: Hoffmann-La Roche — full pipeline
Therapeutic area: All drugs in Cardiovascular
Indication: Drugs for Treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE)
Also known as: Sefaxersen

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing