Last update 27 Mar 2025

Apitegromab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Immunoglobulin g4 (234-proline), anti-(human progrowth differentiation factor 8) (human monoclonal srk-015 .gamma.4-chain), disulfide with human monoclonal srk-015 .lambda.-chain, dimer, SRK 015, SRK-015
Target
Action
inhibitors
Mechanism
MSTN inhibitors(Growth/differentiation factor 8 inhibitors)
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationFast Track (United States), Orphan Drug (United States), Rare Pediatric Disease (United States), Orphan Drug (European Union), Priority Review (United States), PRIME (European Union)
Login to view timeline

Structure/Sequence

External Link

KEGGWikiATCDrug Bank
---

R&D Status

10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Spinal Muscular AtrophyNDA/BLA
United States
30 Jan 2025
AtrophyPhase 3
United States
14 Apr 2022
AtrophyPhase 3
Belgium
14 Apr 2022
AtrophyPhase 3
France
14 Apr 2022
AtrophyPhase 3
Germany
14 Apr 2022
AtrophyPhase 3
Italy
14 Apr 2022
AtrophyPhase 3
Netherlands
14 Apr 2022
AtrophyPhase 3
Poland
14 Apr 2022
AtrophyPhase 3
Spain
14 Apr 2022
AtrophyPhase 3
United Kingdom
14 Apr 2022
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
188
(2-12 years + 10 mg/kg and 20 mg/kg)
mhowsmhuph(titqifxtsy): Difference = 1.8, P-Value = 0.0192
Met
Positive
08 Oct 2024
Placebo
(2-12 years)
Phase 2
Spinal Muscular Atrophy
serum latent myostatin
-
uyvzfpjufl(owarnfyjou) = aaqdpkoniv fvelxolfpv (mfcxbeiytq )
Positive
03 May 2022
uyvzfpjufl(owarnfyjou) = dbrremosdz fvelxolfpv (mfcxbeiytq )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free