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Phase 3; MYOBLOC
Phase 3; MYOBLOC is a Small molecule drug developed by Supernus Pharmaceuticals, Inc.. It is currently in Phase 2 development. Also known as: rimabotulinumtoxinB, botulinum toxin type B.
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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 | Phase 3; MYOBLOC |
|---|---|
| Also known as | rimabotulinumtoxinB, botulinum toxin type B |
| Sponsor | Supernus Pharmaceuticals, Inc. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Efficacy and Safety Study of MYOBLOC in the Treatment of Sialorrhea in Pediatric Subjects (PHASE3)
- Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity (PHASE2, PHASE3)
- Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity (PHASE2, PHASE3)
- Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects (PHASE3)
- Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adults (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:
- Phase 3; MYOBLOC CI brief — competitive landscape report
- Phase 3; MYOBLOC updates RSS · CI watch RSS
- Supernus Pharmaceuticals, Inc. portfolio CI
Frequently asked questions about Phase 3; MYOBLOC
What is Phase 3; MYOBLOC?
Who makes Phase 3; MYOBLOC?
Is Phase 3; MYOBLOC also known as anything else?
What development phase is Phase 3; MYOBLOC in?
Related
- Manufacturer: Supernus Pharmaceuticals, Inc. — full pipeline
- Also known as: rimabotulinumtoxinB, botulinum toxin type B
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing