Drugs / KL590586
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT05265091 | Sep 2021 → Dec 2026 expected | cancer or benign tumor | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2024-05-06 | Klus Pharma Inc. | Regulatory Kelun-Biotech and Ellipses A400 (EP0031) Cleared to Start Ph2 Clinical Development by US FDA kluspharma.com ↗ |
| 2024-05-04 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Regulatory Kelun-Biotech X Ellipses | Second Generation Selective RET Inhibitor A400 (EP0031) Receives FDA Approval for Phase 2 Clinical Trial kelun-biotech.com ↗
has received approval from the U.S. Food and Drug Administration (FDA) to conduct Phase 2 clinical trials for its main product, A400 (also known as KL590586 or EP0031). |
| 2023-11-27 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Regulatory Kelun-Biotech announced that A400/EP0031 has been granted Orphan Drug Designation from the US Food and Drug Administration by ex-China partner Ellipses Pharma kelun-biotech.com ↗
Kelun-Biotech announces that KL590586 (EP0031) (small molecule RET kinase inhibitor, also named A400) program, licensed to global ex-China partner Ellipses Pharma, has been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA) for the treatment of RET fusion-positive solid tumors. |
| 2022-06-28 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Regulatory A400/EP0031 Obtains IND Approval from FDA kelun-biotech.com ↗
The approval is a key step for A400/EP0031 to start a global Phase I/II clinical study. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-05-06 | Klus Pharma Inc. | Kelun-Biotech and Ellipses A400 (EP0031) Cleared to Start Ph2 Clinical Development by US FDA kluspharma.com ↗ |
| 2024-05-04 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Kelun-Biotech X Ellipses | Second Generation Selective RET Inhibitor A400 (EP0031) Receives FDA Approval for Phase 2 Clinical Trial kelun-biotech.com ↗ |
| 2023-11-27 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Kelun-Biotech announced that A400/EP0031 has been granted Orphan Drug Designation from the US Food and Drug Administration by ex-China partner Ellipses Pharma kelun-biotech.com ↗ |
| 2022-06-28 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | A400/EP0031 Obtains IND Approval from FDA kelun-biotech.com ↗ |
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | KL590586 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05265091 ↗ |