Drugs / Lu AG13909
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05669950 | Dec 2022 → Sep 2026 overdue | congenital adrenal hyperplasia | H. Lundbeck A/S | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06471829 | Jun 2024 → Sep 2026 overdue | Cushing syndrome | H. Lundbeck A/S | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-09-11 | H. Lundbeck A/S | Regulatory The U.S. FDA grants orphan drug designation for Lundbeck’s investigational anti-ACTH monoclonal antibody asedebart for treatment of endogenous Cushing’s syndrome lundbeck.com ↗
Lundbeck today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to asedebart (Lu AG13909), Lundbeck’s novel investigational anti-ACTH monoclonal antibody, for the treatment of endogenous Cushing’s syndrome. |
| 2026-06-14 | H. Lundbeck A/S | Results Lundbeck presents new Phase II asedebart data in Cushing’s disease at ENDO 2026 lundbeck.com ↗
The data, presented as an oral presentation at the 2026 Endocrine Society’s Annual Meeting, (ENDO), taking place June 13–16 in Chicago, U.S., showed UFC normalization in 7 out of 8 evaluable patients following individualized intravenous (IV) dose titration of asedebart.1 |
| 2025-06-24 | H. Lundbeck A/S | Regulatory Lundbeck receives orphan drug designation in the US and EU for Lu AG13909 for the treatment of congenital adrenal hyperplasia lundbeck.com ↗
Lundbeck today announced that orphan drug designation has been granted to Lu AG13909 by the US Food and Drug Administration (FDA) on May 12, 2025 and the European Medicines Agency (EMA) on June 20, 2025. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-09-11 | H. Lundbeck A/S | The U.S. FDA grants orphan drug designation for Lundbeck’s investigational anti-ACTH monoclonal antibody asedebart for treatment of endogenous Cushing’s syndrome lundbeck.com ↗ |
| 2026-06-14 | H. Lundbeck A/S | Lundbeck presents new Phase II asedebart data in Cushing’s disease at ENDO 2026 lundbeck.com ↗ |
| 2025-06-24 | H. Lundbeck A/S | Lundbeck receives orphan drug designation in the US and EU for Lu AG13909 for the treatment of congenital adrenal hyperplasia lundbeck.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lu AG13909 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05669950 ↗ |
| Route | Intravenous | “Participants in Part A will receive multiple intravenous (IV) doses of Lu AG13909” NCT05669950 ↗ |