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HGT-1110
HGT-1110 is a Biologic drug developed by Shire. It is currently in Phase 1 development. Also known as: Recombinant human arylsulfatase A.
HGT-1110 is a treatment being studied for Metachromatic Leukodystrophy (MLD), a rare genetic disorder. It is administered as an intervention in clinical trials, alongside other treatments such as Recombinant human arylsulfatase A and SHP611.
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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 | HGT-1110 |
|---|---|
| Also known as | Recombinant human arylsulfatase A |
| Sponsor | Shire |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
- Pyrexia
- Vomiting
- Nasopharyngitis
- Muscle spasticity
- Pain in extremity
- Constipation
- Device malfunction
- Implant site pain
- Wrong technique in drug usage process
- Sleep disorder
- Diarrhoea
- Dysphagia
Key clinical trials
- A Study of Intrathecal SHP611 in Children With Metachromatic Leukodystrophy (PHASE2)
- An Efficacy and Safety Study of HGT-1110 in Participants With Metachromatic Leukodystrophy (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:
- HGT-1110 CI brief — competitive landscape report
- HGT-1110 updates RSS · CI watch RSS
- Shire portfolio CI
Frequently asked questions about HGT-1110
What is HGT-1110?
Who makes HGT-1110?
Is HGT-1110 also known as anything else?
What development phase is HGT-1110 in?
What are the side effects of HGT-1110?
Related
- Manufacturer: Shire — full pipeline
- Also known as: Recombinant human arylsulfatase A
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing