Drugs / Tuspetinib
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT03850574 | Mar 2019 → Nov 2026 expected | acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome with excess blasts-2 | Aptose Biosciences Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 31
| Date | Issuer | Release |
|---|---|---|
| 2026-06-15 | Aptose Biosciences Inc. | Results Aptose Presents Safety, Response, and MRD Clinical Data from TUSCANY Phase 1/2 Clinical Trial of Tuspetinib Triplet Therapy in Newly Diagnosed AML at the 2026 EHA Congress in Oral Presentation aptose.com ↗
Composite complete response (CRc) rate in evaluable patients across all dosing groups was 86.2% |
| 2025-12-06 | Aptose Biosciences Inc. | Results Aptose’s Tuspetinib Triple Drug Therapy Featured at the 2025 ASH Annual Meeting; High Rate of Frontline Clinical Responses Continues Across AML Populations aptose.com ↗
In newly diagnosed AML patients, TUS+VEN+AZA shows promising safety, tolerability and resilient efficacy, including MRD-negative remissions across a broad mutational spectrum |
| 2025-10-16 | Aptose Biosciences Inc. | Results Aptose’s Tuspetinib Exceeds Expectations When Combined with Standard of Care Treatment Across Diverse Populations of Newly Diagnosed AML aptose.com ↗
Addition of TUS to VEN+AZA achieves CR/CRh responses in all (6/6, 100%) patients treated at the higher dose levels of 80 mg and 120 mg TUS, exceeding the 66% rate expected from VEN+AZA alone |
| 2025-08-18 | Aptose Biosciences Inc. | Results Aptose Reports Early Data Demonstrating Tuspetinib Improves Standard of Care Treatment Across Diverse Populations of Newly Diagnosed AML in Phase 1/2 TUSCANY Trial aptose.com ↗
Addition of TUS to VEN+AZA improves response rates; 100% CR/CRh at 80 mg and 120 mg |
| 2025-08-06 | Aptose Biosciences Inc. | Results Aptose Enrollment is Open for 160 mg Dosing Cohort of Tuspetinib in Phase 1/2 TUSCANY Trial of Frontline Triple Drug Therapy aptose.com ↗
TUS+VEN+AZA triplet continues to achieve CRs and minimal residual disease (MRD)-negativity with favorable safety in newly diagnosed AML patients |
| 2025-06-12 | Aptose Biosciences Inc. | Results Aptose Presents Safety, Response, and MRD Clinical Data from TUSCANY Phase 1/2 Clinical Trial of Tuspetinib Triplet Therapy in Newly Diagnosed AML at the 2025 EHA Congress aptose.com ↗
The oral presentation at EHA included updated safety, complete remission, minimal residual disease (MRD) assessments, and longer duration of follow-up: |
| 2025-05-20 | Aptose Biosciences Inc. | Results Aptose Announces Dosing of First Patient with 120 mg of Tuspetinib in Phase 1/2 Tuscany Trial of Frontline Triple Drug Therapy after Dose Escalation Decision by Safety Review Committee aptose.com ↗
No significant safety concerns or dose limiting toxicities (DLTs) have been reported in the TUSCANY trial, including no prolonged myelosuppression of subjects in remission. |
| 2025-05-05 | Aptose Biosciences Inc. | Results Aptose Provides Clinical Update for the Tuspetinib-based Triple Drug Frontline Therapy in Newly Diagnosed AML Patients from the Phase 1/2 TUSCANY Trial aptose.com ↗
Data from the first two cohorts, with a 40 mg or 80 mg dose of tuspetinib in the TUS+VEN+AZA combination, reveal promising clinical safety and antileukemic activity. |
| 2025-02-20 | Aptose Biosciences Inc. | Results Aptose Announces Positive Clinical Safety Review Committee (CSRC) Approval to Dose Escalate in Phase 1/2 Tuscany Trial of Frontline Triple Drug Therapy with Tuspetinib Amid Complete Responses and Favorable Safety in First Cohort aptose.com ↗
No significant safety concerns or dose limiting toxicities (DLTs) have been reported, including no prolonged myelosuppression of subjects in remission. |
| 2025-02-12 | Aptose Biosciences Inc. | Results Aptose’s Frontline Triple Drug Therapy with Tuspetinib Achieves Notable Responses in Newly Diagnosed AML Patients in the Phase 1/2 TUSCANY Trial aptose.com ↗
Two FLT3-WT patients achieved complete remissions (CR and CRh) by the end of Cycle 1. |
| 2024-12-12 | Aptose Biosciences Inc. | Results Aptose Announces Publication of Preclinical Data in AACR Journal Demonstrating Tuspetinib’s Unique Mechanism of Action and Synthetic Lethality on AML Cells When Combined with Venetoclax aptose.com ↗
The publication defines TUS activities on select oncogenic signaling targets, demonstrates enhanced activity and safety of TUS when combined with other agents, and illustrates synthetic lethality when combined with venetoclax (VEN). |
| 2024-12-09 | Aptose Biosciences Inc. | Results Aptose Clinical Data Featured in Poster Presentation at the 2024 ASH Annual Meeting Support Tuspetinib Triple Drug Therapy for Newly Diagnosed AML aptose.com ↗
TUS+VEN retains activity in the difficult-to-treat prior-VEN AML population |
| 2024-08-08 | Aptose Biosciences Inc. | Regulatory Aptose Reports Results for the Second Quarter 2024 aptose.com ↗
TUS+VEN+HMA Triplet Protocol in Frontline Therapy for Newly Diagnosed AML was Reviewed by the FDA and Allowed to Proceed |
| 2024-06-14 | Aptose Biosciences Inc. | Results Aptose Presents Tuspetinib (TUS) Clinical and Preclinical Findings at European Hematology Association (EHA) 2024 Hybrid Congress aptose.com ↗
TUS Monotherapy and TUS+Venetoclax (VEN) Doublet Therapy Show Broad Clinical Activity and Strong Safety Data in relapsed or refractory (R/R) Acute Myeloid Leukemia (AML) and Differentiate TUS from other Investigational Drugs in AML |
| 2023-12-09 | Aptose Biosciences Inc. | Results Aptose Tuspetinib Clinical Data Featured in Oral Presentation at the 2023 ASH Annual Meeting aptose.com ↗
Data were presented in an oral presentation today at the 65 th American Society of Hematology (ASH) Annual Meeting and Exposition by lead investigator Naval G. Daver, M.D., Professor, Director Leukemia Research Alliance Program, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX. |
| 2023-10-30 | Aptose Biosciences Inc. | Results Aptose Presents Highlights from Clinical Update Webcast Featuring Latest Available Data on AML Drug Tuspetinib aptose.com ↗
44% ORR with TUS/VEN in Difficult-to-Treat VEN Failure R/R AML Patients |
| 2023-10-16 | Aptose Biosciences Inc. | Results Aptose Clinical and Preclinical Data to be Presented at European School of Haematology (ESH) 6th International Conference aptose.com ↗
As a single agent, TUS was well-tolerated and highly active across four dose levels among diverse AML genotypes and delivered a 42% CR/CRh across evaluable venetoclax (VEN) naïve patients at the 80mg daily RP2D. |
| 2023-08-24 | Aptose Biosciences Inc. | Results Aptose to Present at the H.C. Wainwright 25th Annual Global Investment Conference aptose.com ↗ |
| 2023-08-10 | Aptose Biosciences Inc. | Results Aptose Reports Results for the Second Quarter 2023 aptose.com ↗ |
| 2023-06-10 | Aptose Biosciences Inc. | Results Aptose Presents Highlights from Clinical Update aptose.com ↗
Aptose provided updated clinical findings with tuspetinib, a potent suppressor of FLT3, SYK, JAK 1/2, mutant forms of |
| 2022-12-11 | Aptose Biosciences Inc. | Results Aptose Announces Updated Clinical Responses, Breadth of Activity, and Safety Across Four Dose Levels of Tuspetinib in Difficult-to-Treat Acute Myeloid Leukemia Populations aptose.com ↗
Tuspetinib Continues to Deliver Single Agent Responses in r/r AML Patients |
| 2022-11-14 | Hanmi Pharmaceutical Company Limited | Results “한미 HM43239, 다양한 용량 투여군에서 ‘완전관해’ 확인” hanmi.co.kr ↗
재발성 또는 불응성 급성골수성백혈병(AML) 환자 대상 글로벌 1/2상 결과 HM43239의 다양한 용량(80mg, 120mg, 160mg) 투여군 모두에서 완전관해 사례를 확인하는 등 성공적 결과가 나왔다 |
| 2022-06-08 | Hanmi Pharmaceutical Company Limited | Results “한미 HM43239, 다양한 용량 투여군에서 ‘완전관해’ 잇따라 확인” hanmi.co.kr ↗
한미약품 파트너사 앱토즈는 지난 3일(한국시각) 진행한 ‘키 오피니언 리더(KOL, Key Opinion Leader)’ 웨비나에서 HM43239의 재발성 또는 불응성 급성골수성백혈병(AML) 환자 대상 글로벌 1/2상 최신 데이터를 발표하면서 “확장 용량인 160mg 투여군에서도 새로운 완전관해(CRi)를 확인했다”고 발표했다. |
| 2022-06-02 | Aptose Biosciences Inc. | Results Aptose Presents Highlights from Corporate Update and KOL Event aptose.com ↗
HM43239 Delivers New Complete Remission at 160mg Dose in AML with Wildtype FLT3 |
| 2022-05-09 | Hanmi Pharmaceutical Company Limited | Regulatory 한미약품 AML 혁신신약, FDA 패스트트랙 개발 품목 지정 hanmi.co.kr ↗
한미약품이 자체 개발한 급성골수성백혈병(AML, acute myeloid leukemia) 치료 혁신신약 HM43239가 미국 FDA의 패스트트랙 개발 품목으로 지정됐다. |
| 2022-05-04 | Aptose Biosciences Inc. | Regulatory Aptose Receives Fast Track Designation for HM43239 in Relapsed/Refractory AML Patients and FLT3 Mutation aptose.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to HM43239, an oral, myeloid kinome inhibitor, for the treatment of patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with FLT3 mutation. |
| 2021-12-14 | Hanmi Pharmaceutical Company Limited | Results “한미 HM43239, 기존 약제 불응성 환자에서 완전관해 확인” hanmi.co.kr ↗
발표에 따르면, HM43239는 재발 혹은 불응성 급성골수성백혈병(AML. Acute Myeloid Luekemia, 이하 AML) 환자에서 지속적인(durable) 단일 요법으로서 항종양 활성화를 입증했다. |
| 2021-12-13 | Aptose Biosciences Inc. | Results HM43239 Demonstrates Durable Clinical Benefit in Acute Myeloid Leukemia aptose.com ↗
HM43239 has demonstrated durable single agent activity in patients with relapsed or refractory acute myeloid leukemia (AML). |
| 2020-12-11 | Hanmi Pharmaceutical Company Limited | Results <보도자료> '한미약품 개발 AML 혁신신약, 완전관해 등 효과 확인' hanmi.co.kr ↗
이 환자에게 HM43239를 투여한 후 1주기(1개월) 후에 완전관해 2) 가 확인됐으며, 약 2주기(2개월) 후에 자가조혈모세포이식(Allogeneic Stem Cell Transplant, ASCT)이 가능한 조건으로 회복돼 이식을 받을 수 있었다. |
| 2019-12-11 | Hanmi Pharmaceutical Company Limited | Results <보도자료> 한미약품, 美 혈액학회서 혈액암 타깃 신약 후보물질 2건 연구결과 발표 hanmi.co.kr ↗
한미약품은 이 행사에서 급성골수성백혈병(AML) 치료제로 개발중인 HM43239의 임상개발 현황에 대해 포스터로 발표했다. |
| 2018-10-31 | Hanmi Pharmaceutical Company Limited | Regulatory <보도자료> 한미약품 차세대 AML 치료제, 美 FDA 희귀의약품 지정 hanmi.co.kr ↗
한미약품은 31일 차세대 급성 골수성 백혈병 치료 신약 후보물질(HM43239)이 최근 미국 FDA로부터 희귀의약품으로 지정됐다고 밝혔다. |
All press releases naming this drug 45 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tuspetinib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03850574 ↗ |
| Known as | HM43239 | “Tuspetinib (HM43239)” NCT03850574 ↗ |
| Action | Inhibit | “indirectly suppresses expression of MCL1” PMID 39665627 ↗ Jan 2025 |
| Modality | Small molecule | “Tuspetinib (TUS) is a well-tolerated, once daily, oral kinase inhibitor” PMID 39665627 ↗ Jan 2025 |
| Route | Oral | “Tuspetinib (TUS) is a well-tolerated, once daily, oral kinase inhibitor” PMID 39665627 ↗ Jan 2025 |
| Target | FLT3 | “TUS targets key prosurvival kinases with IC50 values in the low nmol/L range, including SYK, wild-type (WT) and mutant forms of FLT3” PMID 39665627 ↗ Jan 2025 |
| Target | MCL1 | “and indirectly suppresses expression of MCL1” PMID 39665627 ↗ Jan 2025 |
| Target | SYK | “TUS targets key prosurvival kinases with IC50 values in the low nmol/L range, including SYK” PMID 39665627 ↗ Jan 2025 |