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Hyalase
Hyalase is a Small molecule drug developed by Assiut University. It is currently in Phase 1 development. Also known as: Sonar guided median nerve hydrodissection by hyalase and bupivacaine 0.5%.
Hyalase is a hydrolytic enzyme that belongs to the drug class of HYDROLYTIC ENZYME, and it specifically targets hyaluronic acid through its mechanism of hyaluronic acid hydrolysis. It has been studied in clinical trials for various conditions, including Carpal Tunnel Syndrome, Pain, and Root End Resection.
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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 | Hyalase |
|---|---|
| Also known as | Sonar guided median nerve hydrodissection by hyalase and bupivacaine 0.5% |
| Sponsor | Assiut University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Effect of Local Use of Non-steroidal Anti-inflammatory Agent (Diclofenac Sodium) With and Without Hyaluronidase on Post-surgical Pain and Swelling (NA)
- Wide-Awake Local Anesthesia No Tourniquet (WALANT) With Versus Without Hyaluronidase for Hand Surgery (PHASE2, PHASE3)
- Dexmedetomidine or Hyalase : Which of Them Can Augment Lumbar Epidural Steroid Injection in Failed Back Surgery Patients. A Randomized Clinical Trial (EARLY_PHASE1)
- Ultrasound Guided Shoulder Anterior Capsular Infiltration Plus Hydrodilatation With Steroid Versus Hyalase in Patients With Frozen Shoulder (NA)
- Dexmedetomidine Versus Hyalase Treatment of Carpal Tunnel Syndrome (NA)
- Can Dexmedetomidine With Hyalase Augment Quality and Duration of Analgesia When Added to Lumbar Epidural Steroid in Failed Back Surgery. Randomized Double Blind Study (EARLY_PHASE1)
- Efficacy of Median Nerve Hydrodissection by Hyalase Versus Midazolam in the Treatment of Carpal Tunnel Syndrome: (EARLY_PHASE1)
- Median Nerve Hydro-dissection Using Single Injection of Hyalase as a Novel Treatment of Carpal Tunnel Syndrome (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:
- Hyalase CI brief — competitive landscape report
- Hyalase updates RSS · CI watch RSS
- Assiut University portfolio CI
Frequently asked questions about Hyalase
What is Hyalase?
Who makes Hyalase?
Is Hyalase also known as anything else?
What development phase is Hyalase in?
Related
- Manufacturer: Assiut University — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Sonar guided median nerve hydrodissection by hyalase and bupivacaine 0.5%
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing