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Hunterase
Hunterase is a Biologic drug developed by Green Cross Corporation. It is currently in Phase 3 development for Mucopolysaccharidosis type II. Also known as: GC1111.
Hunterase is a hydrolytic enzyme used to treat Hunter Syndrome (Mucopolysaccharidosis II), specifically targeting heparan sulfate. It is administered as idursulfase-beta, a long-term treatment option for patients with Hunter Syndrome.
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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 | Hunterase |
|---|---|
| Also known as | GC1111 |
| Sponsor | Green Cross Corporation |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
- Mucopolysaccharidosis type II
Common side effects
Key clinical trials
- An Extension Study to Assess the Long-term Safety and Efficacy of Hunterase (Idursulfase Beta) (PHASE3)
- A Study to Evaluate the Safety, Tolerability, PK and PD of Intracerebroventricular GC1123 in Patients with MPS Ⅱ (PHASE1)
- A Study of GC1111 in Hunter Syndrom Patients (PHASE3)
- Safety and Efficacy of Hunterase (PHASE3)
- The Long-term Safety Study of Idursulfase-beta in Hunter Syndrome(Mucopolysaccharidosis II) Patients
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:
- Hunterase CI brief — competitive landscape report
- Hunterase updates RSS · CI watch RSS
- Green Cross Corporation portfolio CI
Frequently asked questions about Hunterase
What is Hunterase?
What is Hunterase used for?
Who makes Hunterase?
Is Hunterase also known as anything else?
What development phase is Hunterase in?
Related
- Manufacturer: Green Cross Corporation — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Mucopolysaccharidosis type II
- Also known as: GC1111
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing