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Lamazym
Lamazym is a Small molecule drug developed by Zymenex A/S. It is currently in Phase 3 development. Also known as: rhLAMAN, recombinant human alpha-mannosidase.
Lamazym is a hydrolytic enzyme used to treat Alpha-Mannosidosis, a condition caused by the deficiency of a high mannose oligosaccharides hydrolytic enzyme. It works by hydrolyzing high mannose oligosaccharides, which is its molecular target.
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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 | Lamazym |
|---|---|
| Also known as | rhLAMAN, recombinant human alpha-mannosidase |
| Sponsor | Zymenex A/S |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Expanded Access to Velmanase Alfa
- Lamazym Aftercare Study (PHASE3)
- Lamazym Aftercare Study FR Designed to Provide Treatment for French Patients (PHASE3)
- Trial on Safety and Efficacy of Velmanase Alfa Treatment in Pediatric Patients With Alpha-Mannosidosis (PHASE2)
- Evaluation of Long-term Efficacy of Treatment With Lamazym (PHASE3)
- A Placebo-Controlled Phase 3 Trial of Repeated Lamazym Treatment of Subjects With Alpha-Mannosidosis (PHASE3)
- Safety Study of Recombinant Human Alpha-mannosidase for the Treatment of Patients With Alpha-mannosidosis (PHASE1)
- Long-term Efficacy and Safety of Lamazym for the Treatment of Patients With Alpha-Mannosidosis (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:
- Lamazym CI brief — competitive landscape report
- Lamazym updates RSS · CI watch RSS
- Zymenex A/S portfolio CI
Frequently asked questions about Lamazym
What is Lamazym?
Who makes Lamazym?
Is Lamazym also known as anything else?
What development phase is Lamazym in?
Related
- Manufacturer: Zymenex A/S — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: rhLAMAN, recombinant human alpha-mannosidase
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing