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Namuscla
Namuscla is a Small molecule drug developed by Grete Andersen, MD. It is currently in Phase 1 development. Also known as: mexiletine.
Namuscla is a small molecule that blocks the sodium channel alpha subunit, classified as a blocker. It is used in the symptomatic management of myotonia in adult patients with non-dystrophic myotonic disorders.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Namuscla |
|---|---|
| Also known as | mexiletine |
| Sponsor | Grete Andersen, MD |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Open-label Extension Study in Paediatric Patients Who Have Completed the MEX-NM-301 Study. (NA)
- An Observational Study in Adult Patients With Non-dystrophic Myotonic Disorders
- Open Label Study in Adolescents and Children With Myotonic Disorders (PHASE3)
- Treatment of Myotonia - Lamotrigine Versus Namuscla (NA)
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:
- Namuscla CI brief — competitive landscape report
- Namuscla updates RSS · CI watch RSS
- Grete Andersen, MD portfolio CI
Frequently asked questions about Namuscla
What is Namuscla?
Who makes Namuscla?
Is Namuscla also known as anything else?
What development phase is Namuscla in?
Related
- Manufacturer: Grete Andersen, MD — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: mexiletine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing