Drugs / FB825
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05952986 | May 2023 → Mar 2024 | atopic eczema | Oneness Biotech Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT02309762 | Mar 2015 → Feb 2016 | — | Fountain Biopharma Inc. | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT06397911 | Aug 2024 → May 2027 expected | atopic eczema | Oneness Biotech Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT05008965 | Jul 2021 → Dec 2027 expected | allergic asthma | Oneness Biotech Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT05059509 | Feb 2020 → May 2021 | atopic eczema | Oneness Biotech Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT03758716 | Jul 2017 → Jan 2019 | atopic eczema | Fountain Biopharma Inc. | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT04413942 Comparator | Mar 2020 → Dec 2021 | atopic eczema | Oneness Biotech Co., Ltd. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2024-05-09 | Oneness Biotech Co., Ltd. | Regulatory 重大訊息－公告美國FDA本日回覆本公司可進行皮下注射劑型FB825抗CεmX單株抗體新藥中重度異位性皮膚炎二期臨床試驗 onenessbio.com ↗
美國FDA本日回覆本公司可進行皮下注射劑型FB825抗CεmX單株抗體新藥中重度異位性皮膚炎二期臨床試驗。 |
| 2024-04-22 | Oneness Biotech Co., Ltd. | Regulatory 重大訊息－公告本公司獲台灣衛生福利部食品藥物管理署(TFDA)核准進行皮下注射劑型FB825抗CεmX單株抗體新藥之中重度異位性皮膚炎二期臨床試驗 onenessbio.com ↗
本公司獲台灣衛生福利部食品藥物管理署(TFDA)核准進行皮下注射劑型FB825抗CεmX單株抗體新藥之中重度異位性皮膚炎二期臨床試驗。 |
| 2024-03-29 | Oneness Biotech Co., Ltd. | Regulatory 重大訊息－公告本公司今日向台灣衛生福利部食品藥物管理署(TFDA)提出皮下注射劑型FB825抗CεmX單株抗體新藥之中重度異位性皮膚炎二期臨床試驗申請 onenessbio.com ↗
向台灣衛生福利部食品藥物管理署提出皮下注射劑型FB825抗CεmX單株抗體新藥之中重度異位性皮膚炎二期臨床試驗申請。 |
| 2024-01-30 | Oneness Biotech Co., Ltd. | Regulatory 重大訊息－公告本公司今日向美國FDA提出皮下注射劑型FB825抗CεmX單株抗體新藥之中重度異位性皮膚炎二期臨床試驗申請 onenessbio.com ↗
向美國FDA提出皮下注射劑型FB825抗CεmX單株抗體新藥之中重度異位性皮膚炎二期臨床試驗申請。 |
| 2023-12-04 | Oneness Biotech Co., Ltd. | Regulatory 重大訊息－公告本公司FB825應用於治療IgE介導的過敏性疾病之專利取得日本專利證書 onenessbio.com ↗
本公司今日取得專利事務所送達之Anti-CεmX人源化單株抗體(FB825)日本專利證書，專利名稱為「治療IgE介導的過敏性疾病」，專利證書號特許第7286665號。 |
All press releases naming this drug 8 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-09-17 | Oneness Biotech Co., Ltd. | 重大訊息-公告本公司Anti-CεmX單株抗體(FB825)取得泰國發明專利 onenessbio.com ↗ |
| 2024-05-09 | Oneness Biotech Co., Ltd. | 重大訊息－公告美國FDA本日回覆本公司可進行皮下注射劑型FB825抗CεmX單株抗體新藥中重度異位性皮膚炎二期臨床試驗 onenessbio.com ↗ |
| 2024-04-22 | Oneness Biotech Co., Ltd. | 重大訊息－公告本公司獲台灣衛生福利部食品藥物管理署(TFDA)核准進行皮下注射劑型FB825抗CεmX單株抗體新藥之中重度異位性皮膚炎二期臨床試驗 onenessbio.com ↗ |
| 2024-03-29 | Oneness Biotech Co., Ltd. | 重大訊息－公告本公司今日向台灣衛生福利部食品藥物管理署(TFDA)提出皮下注射劑型FB825抗CεmX單株抗體新藥之中重度異位性皮膚炎二期臨床試驗申請 onenessbio.com ↗ |
| 2024-01-30 | Oneness Biotech Co., Ltd. | 重大訊息－公告本公司今日向美國FDA提出皮下注射劑型FB825抗CεmX單株抗體新藥之中重度異位性皮膚炎二期臨床試驗申請 onenessbio.com ↗ |
| 2023-12-04 | Oneness Biotech Co., Ltd. | 重大訊息－公告本公司FB825應用於治療IgE介導的過敏性疾病之專利取得日本專利證書 onenessbio.com ↗ |
| 2021-10-13 | Oneness Biotech Co., Ltd. | 重大訊息－公告本公司Anti-CεmX單株抗體(FB825)取得馬來西亞發明專利 onenessbio.com ↗ |
| 2021-04-05 | Oneness Biotech Co., Ltd. | 重大訊息－公告本公司Anti-CεmX單株抗體(FB825)取得印度發明專利 onenessbio.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FB825 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02309762 ↗ |
| Known as | Anti-CemX | “The other name of FB825 is FB825-15D11, or Anti-CemX.” NCT03758716 ↗ |
| Known as | FB825-15D11 | “The other name of FB825 is FB825-15D11, or Anti-CemX.” NCT03758716 ↗ |
| Action | Inhibit | “FB825 blocks the biological pathway of IgE synthesis” NCT04413942 ↗ |
| Route | Intravenous | “IV injection” NCT02309762 ↗ |