Drugs / ATG-016
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT05010525 | Sep 2021 → Nov 2022 | cancer | Antengene Corporation | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04691141 | Feb 2021 → Sep 2023 | myelodysplastic syndrome | Antengene Corporation | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2022-03-30 | Antengene Corporation | Regulatory Antengene Announces IND Approval in China for a Phase II Study of Eltanexor (ATG-016) in Patients with High-Risk Myelodysplastic Syndromes antengene.com ↗
today announced the China National Medical Products Administration (NMPA) has approved a Phase II open-label study designed to evaluate the safety, tolerability and efficacy of the next-generation selective inhibitor of nuclear export (SINE) compound ATG-016 in patients with high-risk myelodysplastic syndromes (MDS). |
| 2021-06-09 | Antengene Corporation | Results Antengene’s Partner Karyopharm Therapeutics Announces Updated Data of Eltanexor in Patients with Hypomethylating Agent Refractory MDS antengene.com ↗
Of the 15 patients evaluable for efficacy, 7 (47%) had marrow complete response (mCR) and 5 (33%) had stable disease (SD) for a total disease control rate (DCR, mCR+SD) of 80% (60% for all patients’ analysis). |
| 2021-05-14 | Antengene Corporation | Regulatory Antengene Announces the IND Approval for Eltanexor in Patients with Advanced Solid Tumors in Mainland China antengene.com ↗
Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, announced that China’s National Medical Products Administration (NMPA) has approved the initiation of a Phase Ib/II open-label, multicenter, dose-escalation study of eltanexor (ATG-016) in patients with advanced solid tumors (the REACH study). |
| 2020-11-26 | Antengene Corporation | Regulatory Approval of Phase I/II Clinical Trial of ATG-016 (Eltanexor), a Second Generation Selective Inhibitor of Nuclear Export (SINE), in Mainland China for the Treatment of Myelodysplastic Syndrome antengene.com ↗
Antengene Corporation Limited (“Antengene”, HKSE stock code: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-inclass therapeutics in hematology and oncology, announced that the National Medical Products Administration (NMPA) has approved the clinical trial of ATG-016 (eltanexor) in patients with intermediate and higher risk myelodysplastic syndrome (MDS) according to the Revised International Prognostic Scoring System (IPSS-R) after the failure of hypomethylating agents (HMA) based therapy. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-03-30 | Antengene Corporation | Antengene Announces IND Approval in China for a Phase II Study of Eltanexor (ATG-016) in Patients with High-Risk Myelodysplastic Syndromes antengene.com ↗ |
| 2021-12-30 | Antengene Corporation | Antengene Announces First Patient Dosed in REACH Study of ATG-016 for the Treatment of Advanced Solid Tumors antengene.com ↗ |
| 2021-06-09 | Antengene Corporation | Antengene’s Partner Karyopharm Therapeutics Announces Updated Data of Eltanexor in Patients with Hypomethylating Agent Refractory MDS antengene.com ↗ |
| 2021-05-14 | Antengene Corporation | Antengene Announces the IND Approval for Eltanexor in Patients with Advanced Solid Tumors in Mainland China antengene.com ↗ |
| 2020-11-26 | Antengene Corporation | Approval of Phase I/II Clinical Trial of ATG-016 (Eltanexor), a Second Generation Selective Inhibitor of Nuclear Export (SINE), in Mainland China for the Treatment of Myelodysplastic Syndrome antengene.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ATG-016 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04691141 ↗ |
| Route | Oral | “ATG-016, orally” NCT04691141 ↗ |