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Adagen
Adagen is a Biologic drug developed by Leadiant Biosciences, Inc.. It is currently in Phase 3 development for Adenosine deaminase deficiency.
Adagen, also known as elapegademase-lvlr, is a hydrolytic enzyme that targets 2'-deoxyadenosine. It is used to treat severe combined immunodeficiency (SCID), including ADA-SCID, XSCID, Leaky SCID, and Omenn 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 | Adagen |
|---|---|
| Sponsor | Leadiant Biosciences, Inc. |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
- Adenosine deaminase deficiency
Common side effects
- Neutropenia
- Cough
- Vomiting
- Dermatitis diaper
- Diarrhoea
- Pyrexia
- Alanine aminotransferase increased
- Aspartate aminotransferase increased
- Anemia
- Rash
- Rhinorrhoea
- Leukopenia
Key clinical trials
- Registry Study of Revcovi Treatment in Patients With ADA-SCID
- Efficacy and Safety of the Cryopreserved Formulation of OTL-101 in Subjects With ADA-SCID (PHASE1, PHASE2)
- Autologous CD34+ Hematopoietic Stem Cells Transduced ex Vivo With Elongation Factor 1 Alpha Shortened (EFS) Lentiviral Vector Encoding for the Human ADA Gene (PHASE1, PHASE2)
- Efficacy and Safety of the Cryopreserved Formulation of OTL-101 in Subjects With ADA-SCID (PHASE1, PHASE2)
- Lentiviral (LV) Gene Therapy for Adenosine Deaminase (ADA) Deficiency (PHASE1, PHASE2)
- MND-ADA Transduction of CD34+ Cells From Children With ADA-SCID (PHASE2)
- Patients Treated for SCID (1968-Present)
- Natural History Study of SCID Disorders
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:
- Adagen CI brief — competitive landscape report
- Adagen updates RSS · CI watch RSS
- Leadiant Biosciences, Inc. portfolio CI
Frequently asked questions about Adagen
What is Adagen?
What is Adagen used for?
Who makes Adagen?
What development phase is Adagen in?
What are the side effects of Adagen?
Related
- Manufacturer: Leadiant Biosciences, Inc. — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Adenosine deaminase deficiency
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing