Drugs / ADL-018
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05413161 | Jul 2022 → Feb 2023 | — | Kashiv BioSciences, LLC | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT06929052 Comparator | Jan → Aug 2025 | — | Kashiv BioSciences, LLC | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-06-25 | Alvotech Swiss AG | Results Positive Top Line Results from Confirmatory Efficacy Study for Proposed Biosimilar to Xolair® (omalizumab) alvotech.com ↗
The study met its primary endpoint, with data demonstrating equivalence of therapeutic endpoints and comparable safety between the biosimilar candidate and the reference biologic. |
| 2025-06-25 | Advanz Pharma | Results Positive Top Line Results from Confirmatory Efficacy Study for Proposed Biosimilar to Xolair® (omalizumab) advanzpharma.com ↗
The study met its primary endpoint, with data demonstrating equivalence of therapeutic endpoints and comparable safety between the biosimilar candidate and the reference biologic. |
| 2025-06-25 | Impax Laboratories, LLC | Results Amneal Highlights Positive Topline Results from Confirmatory Clinical Study of Biosimilar Candidate to XOLAIR(R) (omalizumab), Developed by Kashiv BioSciences amneal.com ↗
The clinical study achieved its primary and secondary endpoints by establishing equivalence of therapeutic endpoints and comparable safety between ADL-018 and XOLAIR ® . |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-06-25 | Alvotech Swiss AG | Positive Top Line Results from Confirmatory Efficacy Study for Proposed Biosimilar to Xolair® (omalizumab) alvotech.com ↗ |
| 2025-06-25 | Advanz Pharma | Positive Top Line Results from Confirmatory Efficacy Study for Proposed Biosimilar to Xolair® (omalizumab) advanzpharma.com ↗ |
| 2025-06-25 | Impax Laboratories, LLC | Amneal Highlights Positive Topline Results from Confirmatory Clinical Study of Biosimilar Candidate to XOLAIR(R) (omalizumab), Developed by Kashiv BioSciences amneal.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 | ADL-018 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06929052 ↗ |
| Known as | ADL-018 Injection | “Reference Product (B): ADL-018 Injection 150mg/mL solution in a single dose pre-filled syringe manufactured/supplied by Kashiv BioSciences LLC, USA” NCT06929052 ↗ |
| Route | Subcutaneous | “following single subcutaneous dose” NCT05413161 ↗ |