Drugs / Rademikibart
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06701149 | Nov 2024 → May 2025 | — | Simcere Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07705737 | Jul → Dec 2026 expected | acute asthma, chronic obstructive pulmonary disease | Connect Biopharm LLC | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06940154 | Aug 2025 → Jul 2026 overdue | chronic obstructive pulmonary disease | Connect Biopharm LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06940141 | Aug 2025 → Jul 2026 overdue | acute asthma | Connect Biopharm LLC | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-04-23 | Connect Biopharm LLC | Results Connect Biopharma Announces Enrollment in Phase 2 Seabreeze STAT Studies Will Continue as Planned Following Pre-Specified Interim Analysis connectbiopharma.com ↗ |
| 2026-03-30 | Connect Biopharm LLC | Results Rademikibart Demonstrates Best-in-Class Potential in Phase 3 Atopic Dermatitis Study connectbiopharma.com ↗
The positive results demonstrated rapid and durable efficacy data through 52 weeks across key endpoints with favorable safety. |
| 2026-03-30 | Connect Biopharm LLC | Results Connect Biopharma Announces Positive Topline Data from its Phase 1 Study of Intravenous (IV) Rademikibart in Patients with Asthma or COPD connectbiopharma.com ↗
Mean FEV 1 improvements of ~200 - 400 mL were maintained through Day 29 in asthma and COPD patients |
| 2026-03-30 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results Rademikibart Phase III Data Presented as Late-Breaking Oral at AAD Annual Meeting simcere.com ↗
Results showed that rademikibart provided rapid relief of itch and improvement in skin inflammation within two weeks, along with high levels of skin clearance that were sustained through 52 weeks. |
| 2026-01-12 | Connect Biopharm LLC | Results Connect Biopharma Highlights New Mechanism of Action Data for Rademikibart and Outlines Priorities for 2026 connectbiopharma.com ↗
The new mechanism of action (MOA) data further demonstrate rademikibart’s unique pharmacologic profile supporting its potential to rapidly reverse the negative effects on airway function of IL-4 and IL-13 resulting in rapid onset of action, greater improvement in FEV 1 and reduced eosinophil-related side effects. |
| 2025-07-09 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory NDA of Rademikibart, Jointly Developed by Simcere and Connect Biopharma for the Treatment of Atopic Dermatitis Accepted by NMPA simcere.com ↗
On July 08, 2025, the new drug application (NDA) of the innovative drug Rademikibart, jointly developed by the Simcere （2096.HK） and Connect Biopharma, was accepted by the National Medical Products Administration (NMPA) for the treatment of atopic dermatitis. |
All press releases naming this drug 9 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Rademikibart | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06701149 ↗ |
| Modality | Monoclonal antibody | — CHEMBL5314768 ↗ |
| Route | Subcutaneous | “300 mg administered subcutaneously on the first day” NCT06701149 ↗ |