Muscular Atrophy, Spinal

16
Pipeline Programs
7
Companies
19
Clinical Trials
4 recruiting
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
0
5
0
3
5
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

RNA Therapeutic
8100%
+ 11 programs with unclassified modality

On Market (2)

Approved therapies currently available

Roche
EVRYSDIApproved
risdiplam
Roche
Survival of Motor Neuron 2 Splicing Modifier [EPC]oral2025
Biogen
SPINRAZAApproved
nusinersen
Biogen
Survival Motor Neuron-2-directed RNA Interaction [EPC]intrathecal2016

Competitive Landscape

6 companies ranked by most advanced pipeline stage

Biogen
BiogenCAMBRIDGE, MA
9 programs
1
3
1
NusinersenPhase 4RNA Therapeutic1 trial
NusinersenPhase 3RNA Therapeutic1 trial
NusinersenPhase 3RNA Therapeutic1 trial
SalanersenPhase 3RNA Therapeutic1 trial
NusinersenPhase 1RNA Therapeutic1 trial
+4 more programs
Active Trials
NCT05618379Active Not Recruiting200Est. Jun 2028
NCT04419233Completed50Est. Nov 2023
NCT04317794Active Not Recruiting74Est. Feb 2027
+6 more trials
Roche
RocheSTAVANGER NORWAY, Norway
6 programs
1
3
2
RisdiplamPhase 41 trial
RisdiplamPhase 41 trial
OlesoximePhase 22 trials
RisdiplamPhase 21 trial
RisdiplamPhase 21 trial
+1 more programs
Active Trials
NCT03920865Completed26Est. Jan 2020
NCT02628743Completed131Est. Dec 2018
NCT02835976Completed6Est. Sep 2014
+4 more trials
Catalyst Pharmaceuticals
Catalyst PharmaceuticalsCORAL GABLES, FL
1 program
1
Amifampridine PhosphatePhase 21 trial
Active Trials
NCT03781479CompletedEst. Jul 2020
Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
1 program
1
somatotropinPhase 21 trial
Active Trials
NCT00533221Completed20Est. Aug 2011
Alcyone Therapeutics
1 program
1
NusinersenPhase 1RNA Therapeutic
Novartis
NovartisBASEL, Switzerland
1 program
Newborn Screening for Spinal Muscular AtrophyN/A1 trial
Active Trials
NCT05481164Completed33,568Est. Jul 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
RocheRisdiplam
RocheRisdiplam
BiogenNusinersen
BiogenSalanersen
BiogenNusinersen
BiogenNusinersen
RocheRisdiplam
Catalyst PharmaceuticalsAmifampridine Phosphate
RocheRisdiplam
RocheOlesoxime
Novo Nordisksomatotropin
BiogenNusinersen
RocheRisdiplam
RocheOlesoxime
BiogenAdult Spinal Muscular Atrophy (SMA) China Registry

Showing 15 of 19 trials with date data

Clinical Trials (19)

Total enrollment: 35,209 patients across 19 trials

A Study Evaluating the Effectiveness and Safety of Risdiplam Administered in Pediatric Patients With Spinal Muscular Atrophy Who Experienced a Plateau or Decline in Function After Gene Therapy

Start: Aug 2024Est. completion: Mar 202928 patients
Phase 4Recruiting

A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy

Start: May 2024Est. completion: Mar 202928 patients
Phase 4Recruiting

A Study to Learn About the Effect of Nusinersen (BIIB058) Given as Injections to Children With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Onasemnogene Abeparvovec (RESPOND)

Start: Jan 2021Est. completion: Oct 202546 patients
Phase 4Completed

A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Onasemnogene Abeparvovec

Start: Sep 2026Est. completion: Jul 203342 patients
Phase 3Not Yet Recruiting

A Study to Learn About the Long-Term Safety of Higher Doses of Nusinersen (BIIB058) Given as Injections to Participants With Spinal Muscular Atrophy (SMA) Who Took Part in an Earlier Nusinersen Trial (ONWARD)

Start: Apr 2021Est. completion: Jul 2026115 patients
Phase 3Active Not Recruiting

Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy

Start: Mar 2020Est. completion: May 2024145 patients
Phase 3Completed

A Study to Investigate the Pharmacokinetics and Safety of Risdiplam in Infants With Spinal Muscular Atrophy

Start: Apr 2024Est. completion: Nov 202610 patients
Phase 2Recruiting

Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 Patients

Start: Jan 2019Est. completion: Jul 2020
Phase 2Completed

Investigate Safety, Tolerability, PK, PD and Efficacy of Risdiplam (RO7034067) in Infants With Type1 Spinal Muscular Atrophy

Start: Dec 2016Est. completion: Dec 202362 patients
Phase 2Completed

A Study to Evaluate Long Term Safety, Tolerability, and Effectiveness of Olesoxime in Patients With Spinal Muscular Atrophy (SMA)

Start: Jan 2016Est. completion: Dec 2018131 patients
Phase 2Completed

Pilot Study of Growth Hormon to Treat SMA Typ II and III

Start: Oct 2007Est. completion: Aug 201120 patients
Phase 2Completed

A Study to Find Out How Nusinersen is Processed in the Body When Given Through the ThecaFlex DRx™ System in Adult and Pediatric Participants With Spinal Muscular Atrophy (PIERRE-PK)

Start: Jan 2025Est. completion: May 202658 patients
Phase 1Recruiting

A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics and Safety and Tolerability of a Single Oral Dose of Risdiplam Compared to Matched Healthy Participants With Normal Hepatic Function

Start: May 2019Est. completion: Jan 202026 patients
Phase 1Completed

A Study of the Excretion Balance of Radiocarbon and the Pharmacokinetics and Metabolic Profile of TRO19622 (Olesoxime)

Start: Jul 2014Est. completion: Sep 20146 patients
Phase 1Completed
NCT05618379BiogenAdult Spinal Muscular Atrophy (SMA) China Registry

Adult Spinal Muscular Atrophy (SMA) China Registry

Start: Jan 2023Est. completion: Jun 2028200 patients
N/AActive Not Recruiting
NCT05481164NovartisNewborn Screening for Spinal Muscular Atrophy

Newborn Screening for Spinal Muscular Atrophy

Start: Mar 2022Est. completion: Jul 202533,568 patients
N/ACompleted
NCT05042921BiogenPediatric Spinal Muscular Atrophy (SMA) China Registry

Pediatric Spinal Muscular Atrophy (SMA) China Registry

Start: Nov 2021Est. completion: Sep 2027600 patients
N/AActive Not Recruiting
NCT04419233BiogenNusinersen Sodium Injection

Non-Interventional, Postmarketing Surveillance Study of Nusinersen Sodium Injection

Start: Nov 2020Est. completion: Nov 202350 patients
N/ACompleted
NCT04317794BiogenNusinersen Sodium Injection

Observational, Postmarketing Surveillance Study of Spinraza Injection (Nusinersen Sodium)

Start: Jul 2019Est. completion: Feb 202774 patients
N/AActive Not Recruiting

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

3 late-stage (Phase 3) programs — potential near-term approvals
4 actively recruiting trials targeting 35,209 patients
7 companies competing in this space