Last reviewed · How we verify
Zenapax
Zenapax is a Small molecule drug developed by National Institute of Neurological Disorders and Stroke (NINDS). It is currently in Phase 3 development for Relapsing remitting multiple sclerosis, Renal transplant rejection.
-
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). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| 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 | Zenapax |
|---|---|
| Sponsor | National Institute of Neurological Disorders and Stroke (NINDS) |
| Target | Interleukin-2 receptor |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | Phase 3 |
Approved indications
- Relapsing remitting multiple sclerosis
- Renal transplant rejection
Common side effects
Key clinical trials
- Islet Transplantation Alone (ITA) in Patients With Difficult to Control Type I Diabetes Mellitus Using a Glucocorticoid-free Immunosuppressive Regimen (PHASE1)
- Prescription Drug Safety and Effectiveness in Multiple Sclerosis
- LMB-2 to Treat Hairy Cell Leukemia (PHASE2)
- Thymoglobulin Versus Campath-1H Versus Daclizumab in Adult, Primary Deceased Donor Renal Transplantation (PHASE4)
- Randomized Trial of 2 Antibody Induction Steroid Avoidance Protocols (PHASE4)
- Thymoglobulin Versus Campath-1H Versus Daclizumab in Adult, Primary Living Donor Renal Transplantation (PHASE4)
- Phase I/II Thymus Transplantation With Immunosuppression #950 (PHASE1, PHASE2)
- Yttrium-90-labeled Daclizumab With Chemotherapy and Stem Cell Transplant for Hodgkin's Lymphoma (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:
- Zenapax CI brief — competitive landscape report
- Zenapax updates RSS · CI watch RSS
- National Institute of Neurological Disorders and Stroke (NINDS) portfolio CI
Frequently asked questions about Zenapax
What is Zenapax?
What is Zenapax used for?
Who makes Zenapax?
What development phase is Zenapax in?
What does Zenapax target?
Related
- Target: All drugs targeting Interleukin-2 receptor
- Manufacturer: National Institute of Neurological Disorders and Stroke (NINDS) — full pipeline
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for Relapsing remitting multiple sclerosis
- Indication: Drugs for Renal transplant rejection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing