Nusinersen - PharmaKB

Spinraza(nusinersen)

Spinraza (nusinersen) is an oligonucleotide pharmaceutical. Nusinersen was first approved as Spinraza on 2016-12-23. It is used to treat spinal muscular atrophy in the USA. It has been approved in Europe to treat spinal muscular atrophy.

Download report

Favorite

Top 200 Pharmaceuticals by Retail Sales

Events Timeline

Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

Max

Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

Mock data
Subscribe for the real data

Commercial

Therapeutic Areas

Therapeutic Area	MeSH
nervous system diseases	D009422

Trade Name

FDA

EMA

Spinraza

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Nusinersen sodium

Tradename	Company	Number	Date	Products
SPINRAZA	Biogen	N-209531 RX	2016-12-23	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
spinraza	New Drug Application	2024-04-24

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
spinal muscular atrophy	EFO_0003823	D009134	G12.1

Agency Specific

FDA

EMA

Expiration	Code
NUSINERSEN SODIUM, SPINRAZA, BIOGEN IDEC
2023-12-23	ODE-127

Patent Expiration

Patent	Expires	Flag	FDA Information
Nusinersen Sodium, Spinraza, Biogen Idec
10436802	2035-09-11		U-1941, U-1942, U-1943, U-1944, U-2093, U-2094
9926559	2034-01-09		U-1943
8980853	2030-11-24		U-1941
9717750	2030-06-17		U-1942, U-1943, U-2093, U-2094
8361977	2030-05-27	DS, DP
7838657	2027-07-11	DP
8110560	2025-12-05		U-1942, U-1943, U-1944
10266822	2025-12-05		U-1942, U-1943, U-1944
7101993	2023-09-05	DP

ATC Codes

M: Musculo-skeletal system drugs

— M09: Other drugs for disorders of the musculo-skeletal system in atc

— M09A: Other drugs for disorders of the musculo-skeletal system in atc

— M09AX: Other drugs for disorders of the musculo-skeletal system in atc

— M09AX07: Nusinersen

HCPCS

Code	Description
J2326	Injection, nusinersen, 0.1 mg

Clinical

Clinical Trials

52 clinical trials

View more details

Mock data
Subscribe for the real data

Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Muscular atrophy	D009133	HP_0003202	—	6	4	8	2	31	50
Spinal muscular atrophy	D009134	EFO_0003823	G12.1	6	4	8	2	31	50
Atrophy	D001284	—	—	6	4	8	2	26	45

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Spinal muscular atrophies of childhood	D014897	Orphanet_83419	G12.1	—	—	1	—	2	3
Neuromuscular diseases	D009468	EFO_1001902	G70.9	—	—	1	—	1	2
Neuromuscular manifestations	D020879	—	—	—	—	1	—	—	1

Indications Phases 2

No data

Indications Phases 1

No data

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Ultrasonography	D014463	—	—	—	—	—	—	2	2
Amyotrophic lateral sclerosis	D000690	HP_0007354	G12.21	—	—	—	—	2	2
Motor neuron disease	D016472	EFO_0003782	G12.2	—	—	—	—	2	2
Tremor	D014202	HP_0001337	R25.1	—	—	—	—	1	1
Dyskinesias	D020820	HP_0002310	G24	—	—	—	—	1	1
Hyperkinesis	D006948	HP_0000752	—	—	—	—	—	1	1
Spinal anesthesia	D000775	—	—	—	—	—	—	1	1
Spinal puncture	D013129	—	—	—	—	—	—	1	1
Fatigue	D005221	HP_0012378	R53.83	—	—	—	—	1	1
Scoliosis	D012600	EFO_0004273	M41	—	—	—	—	1	1

Show 1 more

Epidemiology

Epidemiological information for investigational and approved indications

View more details

Drug

General

Drug common name	Nusinersen
INN	nusinersen
Description	Nusinersen, marketed as Spinraza, is a medication used in treating spinal muscular atrophy (SMA), a rare neuromuscular disorder. In December 2016, it became the first approved drug used in treating this disorder.
Classification	Oligonucleotide
Drug class	antisense oligonucleotides: neurologic indications
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	—