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myoblast
myoblast is a Biologic drug developed by Mytogen, Inc.. It is currently in Phase 2 development.
Myoblasts are precursor cells that can either proliferate or differentiate into multinucleated fibers called myotubes, particularly during embryonic development. Myoblasts have been studied in clinical trials for various conditions, including old myocardial infarction, laminopathies, and dilated cardiomyopathy-1A, through interventions such as percutaneous autologous myoblast implantation.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | myoblast |
|---|---|
| Sponsor | Mytogen, Inc. |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Modifying Factors in Striated Muscle Laminopathies (NA)
- " Development of Primary Cultures of Diaphragmatic Myoblasts for Basic Research Purposes "
- Evaluate the Effort Test as a Therapeutic Monitoring Tool in Acute Rhabdomyolyses
- Metabolic Phenotyping in Humans
- Transplantation of Myoblasts to Duchenne Muscular Dystrophy (DMD) Patients (PHASE1, PHASE2)
- Treatment of Ptosis to Muscular Dystrophy Oculopharyngeal by Myoblast Autologous Graft (PHASE2, PHASE3)
- Tissue Donation for Myoblast Culture (NA)
- To Assess Safety and Efficacy of Myoblast Implantation Into Myocardium Post Myocardial Infarction (PHASE2, PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- myoblast CI brief — competitive landscape report
- myoblast updates RSS · CI watch RSS
- Mytogen, Inc. portfolio CI
Frequently asked questions about myoblast
What is myoblast?
Who makes myoblast?
What development phase is myoblast in?
Related
- Manufacturer: Mytogen, Inc. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing