To Get Full Access :

aBLA Filing Intelligence & Biosimilar Opportunity

Isembyld

Apitegromab-Mstn
Injectable Injection

Isembyld (apitegromab) is a monoclonal antibody indicated for the treatment of spinal muscular atrophy (SMA) in adults and pediatric patients 2 years of age and older who are receiving an SMN2-targeted treatment.

Unlike therapies that primarily address the underlying SMN protein deficiency, apitegromab is designed to target muscle loss by inhibiting the activation of myostatin, a protein that limits muscle growth. As the first approved therapy specifically designed to target muscle loss in spinal muscular atrophy, Isembyld offers a complementary treatment approach alongside SMN2-targeted therapies.

By addressing muscle function and wasting, it aims to improve motor outcomes in patients who continue to experience physical limitations despite disease-modifying treatment. Its mechanism represents an important expansion of the therapeutic landscape for SMA.

Approval Date
11-Sep-26
Data Exclusivity Expiry
11-Sep-30
Market Exclusivity Expiry
11-Sep-38
Commercial snapshot

Market performance & projections

Revenue ($M)
NA
CAGR (%)
NA
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
NA
2027
NA
2028
NA
2029
NA
2030
NA
2031
NA
2032
NA
Molecule profile

Details & specifications

Molecule
Apitegromab-Mstn
Innovator
SCHOLAR ROCK INC
Dosage Form
Injectable Injection
Strength
150mg/3ml (50mg/ml)
Therapeutic Category
Usage
To treat spinal muscular atrophy in adults and pediatric patients 2 years of age and older who are currently receiving an SMN2-targeted treatment
Good to know

Frequently asked questions

Ready to act on this opportunity?

Talk to Spring Bio Solution about sourcing, licensing, and filing support for this molecule.

Why Spring Bio Solution

Supported 1000+ clinical trials globally

Provides services across regulatory, legal & clinical research

Unmatched intelligence on batches, expiry, spacing, and historical data from innovators

Integrated CRO services as part of our offerings

Insights on global pricing for smarter clinical trial supply decisions

Global sourcing capability across US, EU, South Africa, Canada, Japan, Australia, New Zealand, Southeast Asia, and other key markets

Login With

For full access Sign-up / Sign-in using below Methods:

By continuing, you agree to our Terms & Conditions and Privacy Policy. You can review them anytime.

Are you sure want to logout from NCE Grid?