Nusinersen

Orphan Drug Cold Chain RequiredUnregistered in India

Description

Nusinersen is an antisense oligonucleotide drug used to treat spinal muscular atrophy (SMA). It works by modifying the splicing of the SMN2 gene to produce more functional SMN protein.

Indications & Therapeutic Use

Spinal Muscular Atrophy (SMA) types 1, 2, and 3

Linked Diseases:

Spinal Muscular Atrophy
G12.0D009134

Evidence: Phase 3 ENDEAR trial

Global Availability (3 countries)

CountryAccess RouteRegulatory PathwayLead TimeStatus
Named Patient5 daysAvailable via NPP
EAMSUK Early Access to Medicines Scheme (EAMS)10 daysAvailable via EAMS
Named PatientIndia Named Patient Import (Form 12B)7 daysAvailable via NPP

Access Programs

Named Patient ProgramNamed Patient Program

Framework: Country-specific regulatory approvals

Typical timeline: 21 days

Available Through

This drug is available for procurement through the following fulfilment partner.

Fulfilment Partner
Nusinersen
Generic NameNusinersen
Brands1 brand available
Active IngredientNusinersen sodium
Drug ClassSpinal Muscular Atrophy (SMA) types 1
ManufacturerBiogen
Dosage FormsIntrathecal injection 12mg/5mL
Medical CodeRxNorm:1860484
Orphan StatusYes — Orphan Drug
Cold ChainRequired
Lead Time7 days
Reg. StatusUnregistered in India
Countries3 countries
Authority Signals
Last Verified3/11/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations4 Validated Nodes