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Hylase
Hylase is a Small molecule drug developed by Assiut University. It is currently in Phase 1 development. Also known as: ( group I ), Hyaluronidase.
Hylase is being studied as a potential treatment for conditions such as Carpal Tunnel Syndrome, chronic pain, and neuropathic pain, particularly in patients with treatment-resistant carpal tunnel in rheumatoid arthritis. It is being investigated through a single injection of hyalase as a novel treatment for carpal tunnel syndrome, with comparisons made to saline and dexmedetomidine in clinical trials.
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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 | Hylase |
|---|---|
| Also known as | ( group I ), Hyaluronidase |
| Sponsor | Assiut University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Dexmedetomidine or Hyalase : Which of Them Can Augment Lumbar Epidural Steroid Injection in Failed Back Surgery Patients. A Randomized Clinical Trial (EARLY_PHASE1)
- 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)
- Median Nerve Hydro-dissection Using Single Injection of Hyalase as a Novel Treatment of Carpal Tunnel Syndrome (NA)
- ُEfficacy of Insulin Versus Hyalase Hydro-dissection of Median Nerve in Rheumatoid Arthritis Patients (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:
- Hylase CI brief — competitive landscape report
- Hylase updates RSS · CI watch RSS
- Assiut University portfolio CI
Frequently asked questions about Hylase
What is Hylase?
Who makes Hylase?
Is Hylase also known as anything else?
What development phase is Hylase in?
Related
- Manufacturer: Assiut University — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: ( group I ), Hyaluronidase
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing