Drugs / EBDAROKIMAB
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | pustular psoriasis | 2023-08-23 | “2023年8月23日，国家药品监督管理局药品审评中心（NMPA CDE）官网显示，康方生物（9926. HK）自主研发的靶向于IL-12/IL-23的全人源单克隆抗体依若奇单抗（AK101）的新药上市许可申请（NDA）已经被受理，用于治疗中度至重度斑块型银屑病.” akesobio.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06281704 | Nov 2020 → May 2022 | ulcerative colitis | Akeso | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04172233 | Jan 2018 → Oct 2019 | psoriasis | Akeso | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04173637 | Dec 2019 → Mar 2022 | psoriasis | Akeso | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT05509361 | Apr 2022 → Nov 2023 | psoriasis | Akeso | Completed | No outcome recorded |
| Phase 3 | NCT05120297 | Nov 2021 → Sep 2022 | psoriasis | Akeso | Completed | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-04-02 | Akeso | Results 首届康方免疫论坛圆满召开，探索自身免疫疾病治疗新纪元 akesobio.com ↗ |
| 2023-10-13 | Akeso | Results 康方IL-12/IL-23单抗依若奇治疗中重度银屑病Ⅲ期临床结果发表于EADV 2023 akesobio.com ↗ |
| 2023-08-24 | Akeso | Regulatory 首个国产新药IL-12/IL-23单抗报产！康方生物依若奇单抗NDA获NMPA受理 akesobio.com ↗ |
| 2023-07-04 | Akeso | Results 康方生物IL-12/23单抗中重度溃疡性结肠炎研究成果发表于FOCIS 2023 akesobio.com ↗ |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-04-02 | Akeso | 首届康方免疫论坛圆满召开，探索自身免疫疾病治疗新纪元 akesobio.com ↗ |
| 2023-10-13 | Akeso | 康方IL-12/IL-23单抗依若奇治疗中重度银屑病Ⅲ期临床结果发表于EADV 2023 akesobio.com ↗ |
| 2023-08-24 | Akeso | 首个国产新药IL-12/IL-23单抗报产！康方生物依若奇单抗NDA获NMPA受理 akesobio.com ↗ |
| 2023-07-04 | Akeso | 康方生物IL-12/23单抗中重度溃疡性结肠炎研究成果发表于FOCIS 2023 akesobio.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | EBDAROKIMAB | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650437 ↗ |
| Known as | AK101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05509361 ↗ |
| Modality | Monoclonal antibody | “anti-IL-12/23p40 monoclonal antibody” NCT04172233 ↗ |
| Route | Subcutaneous | “when administered subcutaneously” NCT04172233 ↗ |