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rhASA - Dose Level 3
rhASA - Dose Level 3 is a Biologic drug developed by Shire. It is currently in Phase 1 development. Also known as: HGT-1111, metazym.
Here's a 2-sentence factual summary of rhASA - Dose Level 3: There is no information available on rhASA - Dose Level 3. However, rhASA is a recombinant human arylsulfatase A used to treat Metachromatic Leukodystrophy (MLD) and Late Infantile Metachromatic Leukodystrophy, administered intrathecally as part of a multicenter study.
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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 | rhASA - Dose Level 3 |
|---|---|
| Also known as | HGT-1111, metazym |
| Sponsor | Shire |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Metazym for the Treatment of Patients With Late Infantile Metachromatic Leukodystrophy (MLD) (PHASE1)
- Long-term Metazym Treatment of Patients With Late Infantile Metachromatic Leukodystrophy (MLD) (PHASE1, PHASE2)
- Multicenter Study of HGT-1110 Administered Intrathecally in Children With Metachromatic Leukodystrophy (MLD) (PHASE1, PHASE2)
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:
- rhASA - Dose Level 3 CI brief — competitive landscape report
- rhASA - Dose Level 3 updates RSS · CI watch RSS
- Shire portfolio CI
Frequently asked questions about rhASA - Dose Level 3
What is rhASA - Dose Level 3?
Who makes rhASA - Dose Level 3?
Is rhASA - Dose Level 3 also known as anything else?
What development phase is rhASA - Dose Level 3 in?
Related
- Manufacturer: Shire — full pipeline
- Also known as: HGT-1111, metazym
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing