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Sirdalud
Sirdalud is a Small molecule drug developed by Bausch Health Americas, Inc.. It is currently in Phase 3 development.
Sirdalud is a brand name for the medication tizanidine, which is a small molecule that acts as an alpha-2 (α2) adrenergic receptor agonist. It is used to treat muscle spasticity due to spinal cord injury, multiple sclerosis, and spastic cerebral palsy.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Sirdalud |
|---|---|
| Sponsor | Bausch Health Americas, Inc. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Interaction of CYP2B6 Genotype and Efavirenz With Methadone and Tizanidine PK (EARLY_PHASE1)
- Opioid-Free Pain Protocol After Shoulder Arthroplasty (PHASE4)
- Efficacy and Safety of Pregabalin/Tizanidine vs. Pregabalin in Patients With Fibromyalgia (NA)
- Bi-level Erector Spinae Plane Block and Pre-emptive Oral Tizanidine for Analgesia After Mastectomy Surgery (NA)
- Efficacy and Safety of Etoricoxib/Tizanidine Versus Etoricoxib for Acute Low Back Pain Associated to Muscle Spasm (PHASE3)
- Comparison of Analgesic Efficacy of Intrathecal Levobupivacaine With and Without Oral Tizanidine in Lower Limb Surgeries: A Prospective Randomized Study (PHASE4)
- Tizanidine and Acoustic Reflex (NA)
- Effect of Tizanidine on Postoperative Urinary Retention After Sacrospinous Suspension (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:
- Sirdalud CI brief — competitive landscape report
- Sirdalud updates RSS · CI watch RSS
- Bausch Health Americas, Inc. portfolio CI
Frequently asked questions about Sirdalud
What is Sirdalud?
Who makes Sirdalud?
What development phase is Sirdalud in?
Related
- Manufacturer: Bausch Health Americas, Inc. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing