Drugs / CID-103
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | primary thrombocytopenia | 2024-04-12 | “CASI submitted the IND application to the FDA for CID-103 to support a phase 1/2 study of CID-103 in adults with chronic Immune Thrombocytopenia (ITP).” issuerdirect.com ↗ “April 12, 2024 CASI submitted the IND application to the FDA for CID-103 to support a phase 1/2 study of CID-103” issuerdirect.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04758767 | Mar 2021 → Jan 2023 | plasma cell myeloma | CASI pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07641426 | Jun 2026 → May 2030 expected | transplant rejection | CASI pharmaceuticals, Inc. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07017725 | Jan 2025 → Jun 2026 overdue | thrombocytopenia due to immune destruction | CASI pharmaceuticals, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-01-15 | CASI pharmaceuticals, Inc. | Regulatory CASI Pharmaceuticals Announces Approval of Clinical Trial Application by China NMPA for Phase 1 / 2 Study of CID-103 for Renal Allograft Antibody-Mediated Rejection (AMR) issuerdirect.com ↗
China National Medical Products Administration (NMPA) has approved a Clinical Trial Application (CTA) to conduct a Phase 1 /2 clinical trial for CID-103 in adults with chronic active renal allograft antibody-mediated rejection (AMR). |
| 2026-01-12 | CASI pharmaceuticals, Inc. | Results CASI Pharmaceuticals Announces Update and Additional Results from Phase 1 Study of CID-103 in Adult Patients with Chronic Immune Thrombocytopenia issuerdirect.com ↗
CID-103 demonstrated a manageable safety profile with only two Grade 3 treatment-related events and no dose limiting toxicities observed |
| 2025-12-08 | CASI pharmaceuticals, Inc. | Results CASI Pharmaceuticals Announces Results from CID-103 Immune Thrombocytopenia Study at the 67th American Society of Hematology (ASH) Annual Meeting issuerdirect.com ↗
CID-103 demonstrated a manageable safety profile with only two Grade 3 treatment-related events and no dose limiting toxicities observed |
| 2025-09-08 | CASI pharmaceuticals, Inc. | Results CASI Pharmaceuticals Announces Safety Monitoring Committee Recommendation to Escalate CID-103 Dose to Next Cohort in Phase 1 Immune Thrombocytopenia (ITP) Study issuerdirect.com ↗
The SMC has recommended that the trial continue and the dose escalation to cohort 5 (900 mg target dose) may proceed as per the protocol design. |
| 2025-08-04 | CASI pharmaceuticals, Inc. | Regulatory CASI Pharmaceuticals Announces FDA Clearance of IND Application for CID-103 in Renal Allograft Antibody-Mediated Rejection (AMR) issuerdirect.com ↗
CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing innovative therapies for patients with organ transplant rejection and autoimmune diseases, today announced FDA clearance of an IND application for CID-103, an anti-CD38 monoclonal antibody in adults with active and chronic active renal allograft antibody mediated rejection (AMR). |
| 2024-11-15 | CASI pharmaceuticals, Inc. | Regulatory CASI Pharmaceuticals Announces Third Quarter 2024 Business and Financial Results issuerdirect.com ↗
We just announced the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved our Clinical Trial Application (CTA) for a phase 1/2 study of CID-103 in patients with chronic Immune Thrombocytopenia (ITP) in China. |
| 2024-10-24 | CASI pharmaceuticals, Inc. | Regulatory CASI Pharmaceuticals Receives CTA Approval From China's NMPA for CID-103 in Immune Thrombocytopenia issuerdirect.com ↗
Following the IND clearance by the FDA and the subsequent CTA approval in China, CASI continues to demonstrate its global commitment to develop innovative therapies to address unmet medical need in autoimmune diseases. |
| 2024-05-15 | CASI pharmaceuticals, Inc. | Regulatory CASI Pharmaceuticals Receives FDA Clearance On The Investigational New Drug (IND) Application For CID-103 In Immune Thrombocytopenia (ITP) issuerdirect.com ↗
On May 13, 2024 CASI received a letter from FDA indicating that study may proceed. |
| 2020-06-08 | CASI pharmaceuticals, Inc. | Regulatory CASI Pharmaceuticals Announces Submission Of Clinical Trial Application (IND) To Conduct Phase 1 Study For Anti-38 Monoclonal Antibody Program issuerdirect.com ↗
CASI Pharmaceuticals Announces Submission Of Clinical Trial Application (IND) To Conduct Phase 1 Study For Anti-38 Monoclonal Antibody Program |
All press releases naming this drug 15 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CID-103 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07017725 ↗ |
| Modality | Monoclonal antibody | “anti-CD38 antibody” NCT04758767 ↗ |
| Route | Intravenous | “Route of administration: IV infusion.” NCT07017725 ↗ |
| Target | CD38 | “anti-CD38 antibody” NCT04758767 ↗ |