Drugs / SC-101
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07483372 | Mar 2026 → Dec 2027 expected | chronic kidney disease, resistant hypertension | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 1 | NCT06220838 | Feb 2024 → Mar 2026 overdue | neoplasm | Tianjin ConjuStar Biologics Co., Ltd. | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07080619 | Sep 2025 → Jul 2027 expected | hormone receptor-positive breast cancer, triple-negative breast carcinoma | Tianjin ConjuStar Biologics Co., Ltd. | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-04-29 | Tianjin ConjuStar Biologics Co., Ltd. | Regulatory SC-101 granted ODD by FDA for the treatment of esophageal cancer conjustar.com ↗
On April 27, 2025, Conjustar biologics announced that SC-101 (Nectin-4-targeting PDC) has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of esophageal cancer. |
| 2024-05-31 | Tianjin ConjuStar Biologics Co., Ltd. | Regulatory SC-101 has received Investigational New Drug (IND) approval from the U.S. Food and Drug conjustar.com ↗
On May 31, 2024, Conjustar Biologics announced that its Nectin-4 targeting PDC drug SC-101 has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) |
| 2024-01-03 | Tianjin ConjuStar Biologics Co., Ltd. | Regulatory First in China: SC-101, a Peptide Drug Conjugate (PDC), has been approved by the Chinese National Medical Products Administration. conjustar.com ↗
On January 2, 2024, the company's first Peptide-Drug Conjugate (PDC), SC-101, was approved by the Chinese National Medical Products Administration for the treatment of patients with malignant solid tumors that expressed Nectin-4. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-04-29 | Tianjin ConjuStar Biologics Co., Ltd. | SC-101 granted ODD by FDA for the treatment of esophageal cancer conjustar.com ↗ |
| 2024-05-31 | Tianjin ConjuStar Biologics Co., Ltd. | SC-101 has received Investigational New Drug (IND) approval from the U.S. Food and Drug conjustar.com ↗ |
| 2024-01-03 | Tianjin ConjuStar Biologics Co., Ltd. | First in China: SC-101, a Peptide Drug Conjugate (PDC), has been approved by the Chinese National Medical Products Administration. conjustar.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SC-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06220838 ↗ |
| Modality | Small interfering RNA (siRNA) | “SC101, a small interfering RNA (siRNA) agent” NCT07483372 ↗ |
| Route | Intravenous | “single intravenous (IV) infusion of SC-101” NCT06220838 ↗ |