Last reviewed 2026-04-22 · How we verify

Edaravone Dexborneol Sequential Therapy

Simcere Pharmaceutical Co., Ltd · Phase 3 active Small molecule

Edaravone Dexborneol Sequential Therapy is a Neuroprotective agent combination Small molecule drug developed by Simcere Pharmaceutical Co., Ltd. It is currently in Phase 3 development for Acute ischemic stroke.

Edaravone reduces oxidative stress and neuroinflammation while dexborneol enhances cerebral blood flow and neuroprotection in a sequential combination therapy.

Edaravone reduces oxidative stress and neuroinflammation while dexborneol enhances cerebral blood flow and neuroprotection in a sequential combination therapy. Used for Acute ischemic stroke.

Likelihood of approval

55.3% 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).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

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	Edaravone Dexborneol Sequential Therapy
Sponsor	Simcere Pharmaceutical Co., Ltd
Drug class	Neuroprotective agent combination
Modality	Small molecule
Therapeutic area	Neurology
Phase	Phase 3

Mechanism of action

Edaravone is a free radical scavenger that protects neurons from oxidative damage, particularly in acute ischemic stroke. Dexborneol, a monoterpene alcohol, improves microcirculation and has anti-inflammatory properties. The sequential administration is designed to optimize neuroprotection by first reducing oxidative stress followed by improving cerebral perfusion and reducing secondary neuronal injury.

Approved indications

Acute ischemic stroke

Common side effects

Headache
Dizziness
Nausea
Injection site reactions

Key clinical trials

The Efficacy and Safety of Edaravone Dexborneol Sequential Therapy in the Treatment of Patients With AIS (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:

Edaravone Dexborneol Sequential Therapy CI brief — competitive landscape report
Edaravone Dexborneol Sequential Therapy updates RSS · CI watch RSS
Simcere Pharmaceutical Co., Ltd portfolio CI

Frequently asked questions about Edaravone Dexborneol Sequential Therapy

What is Edaravone Dexborneol Sequential Therapy?

Edaravone Dexborneol Sequential Therapy is a Neuroprotective agent combination drug developed by Simcere Pharmaceutical Co., Ltd, indicated for Acute ischemic stroke.

How does Edaravone Dexborneol Sequential Therapy work?

Edaravone reduces oxidative stress and neuroinflammation while dexborneol enhances cerebral blood flow and neuroprotection in a sequential combination therapy.

What is Edaravone Dexborneol Sequential Therapy used for?

Edaravone Dexborneol Sequential Therapy is indicated for Acute ischemic stroke.

Who makes Edaravone Dexborneol Sequential Therapy?

Edaravone Dexborneol Sequential Therapy is developed by Simcere Pharmaceutical Co., Ltd (see full Simcere Pharmaceutical Co., Ltd pipeline at /company/simcere-pharmaceutical-co-ltd).

What drug class is Edaravone Dexborneol Sequential Therapy in?

Edaravone Dexborneol Sequential Therapy belongs to the Neuroprotective agent combination class. See all Neuroprotective agent combination drugs at /class/neuroprotective-agent-combination.

What development phase is Edaravone Dexborneol Sequential Therapy in?

Edaravone Dexborneol Sequential Therapy is in Phase 3.

What are the side effects of Edaravone Dexborneol Sequential Therapy?

Common side effects of Edaravone Dexborneol Sequential Therapy include Headache, Dizziness, Nausea, Injection site reactions.

Drug class: All Neuroprotective agent combination drugs
Manufacturer: Simcere Pharmaceutical Co., Ltd — full pipeline
Therapeutic area: All drugs in Neurology
Indication: Drugs for Acute ischemic stroke

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