Drugs / EI-001
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04994912 | Oct 2021 → Jan 2025 | — | Elixiron Immunotherapeutics (Hong Kong) Ltd. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07223229 | Dec 2025 → Dec 2026 expected | vitiligo | Elixiron Immunotherapeutics (Hong Kong) Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2023-09-08 | Elixiron Immunotherapeutics Inc. | Regulatory EI-001, Elixiron's drug candidate for treating vitiligo, has received approval for a clinical trial in China from the National Medical Products Administration elixiron.com ↗
With the recent approval for the clinical trial in China, we are poised to vigorously progress and will initiate more clinical trials specifically tailored to individuals with vitiligo. |
| 2023-05-25 | Elixiron Immunotherapeutics Inc. | Results A new mechanism of IFN-γ in the pathogenesis of vitiligo reveald by a discovery from the collaborative research of Chang-Gung University and Elixiron elixiron.com ↗
The study also discovered that EI-001, a fully human anti-IFN-γ monoclonal antibody developed by Elixiron, effectively prevents IFN-γ-induced damages to melanocytes and restores the melanin-producing capability, providing a new perspective for the treatment of vitiligo. |
| 2022-09-06 | Elixiron Immunotherapeutics Inc. | Regulatory Elixiron Immunotherapeutics Announces Orphan Drug Designation Granted to Interferon-Gamma-Neutralizing Antibody, EI 001 for the Treatment of Hemophagocytic Lymphohistiocytosis elixiron.com ↗
The U.S. FDA has granted Orphan Drug Designation to our interferon-gamma-neutralizing antibody, EI-001 for the treatment of hemophagocytic lymphohistiocytosis, a life-threatening disease in children and adults requiring aggressive intervention to control the symptoms that are driven in large part by aberrant or excessive interferon-gamma production. |
| 2021-08-23 | Elixiron Immunotherapeutics Inc. | Regulatory Boehringer Ingelheim and Elixiron’s EI-001 Achieves Successful Clinical Submission elixiron.com ↗
Boehringer Ingelheim today announced that EI-001, a monoclonal antibody co-developed with Elixiron Immunotherapeutics, has successfully completed clinical submission and is set to begin a Phase I clinical trial in Australia. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-09-08 | Elixiron Immunotherapeutics Inc. | EI-001, Elixiron's drug candidate for treating vitiligo, has received approval for a clinical trial in China from the National Medical Products Administration elixiron.com ↗ |
| 2023-05-25 | Elixiron Immunotherapeutics Inc. | A new mechanism of IFN-γ in the pathogenesis of vitiligo reveald by a discovery from the collaborative research of Chang-Gung University and Elixiron elixiron.com ↗ |
| 2022-09-06 | Elixiron Immunotherapeutics Inc. | Elixiron Immunotherapeutics Announces Orphan Drug Designation Granted to Interferon-Gamma-Neutralizing Antibody, EI 001 for the Treatment of Hemophagocytic Lymphohistiocytosis elixiron.com ↗ |
| 2021-08-23 | Elixiron Immunotherapeutics Inc. | Boehringer Ingelheim and Elixiron’s EI-001 Achieves Successful Clinical Submission elixiron.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | EI-001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04994912 ↗ |
| Modality | Monoclonal antibody | “EI-001 Monoclonal Antibody” NCT04994912 ↗ |
| Route | Intravenous | “IV infusion” NCT04994912 ↗ |