Drugs / Asciminib
Asciminib
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic myeloid leukemia 3 milestones | |||||
| Filed | EU (EMA) | Scemblix | chronic myeloid leukemia | 2025-04-29 | “Abschluss des EU-Zulassungsantrags für Scemblix bei Erwachsenen mit neu diagnostizierter chronischer myeloischer Leukämie (CML)” novartis.com ↗ “Regulatory submission for Scemblix in adults with newly diagnosed CML was completed in the EU based on 96-week data” novartis.com ↗ |
| Filed | US (FDA) | Scemblix | chronic myeloid leukemia | 2024-07-18 | “Der FDA-Zulassungsantrag für die Erstbehandlung chronischer myeloischer Leukämie (CML) wurde abgeschlossen” novartis.com ↗ “La demande d'autorisation auprès de la FDA pour la LMC en première intention est terminée” novartis.com ↗ “FDA submission for first-line CML is completed and under Real-Time Oncology Review.” novartis.com ↗ |
| Filed | US (FDA) | — | chronic myeloid leukemia | 2021-07-21 | “Asciminib (ABL001) Bei der FDA wurde ein Zulassungsantrag eingereicht für die Behandlung erwachsener Patienten mit Philadelphia-Chromosom-positiver chronischer myeloischer Leukämie” novartis.com ↗ “Asciminib (ABL001) Has been submitted to the FDA for treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase” novartis.com ↗ “Asciminib (ABL001) Demande d’homologation déposée auprès de la FDA pour traiter les adultes souffrant de leucémie myéloïde chronique” novartis.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (5) | US (FDA) | SCEMBLIX | — | 2022-10-12 – 2025-11-25 | fda.gov ↗ |
| Approved | EU (EMA) | Scemblix | — | 2022-08-25 | europa.eu ↗ |
| Approved | US (FDA) | SCEMBLIX | — | 2021-10-29 | fda.gov ↗ |
Trials 37
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07039760 | Oct 2026 → Apr 2028 expected | brain neoplasm | Washington University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 16 trials | ||||||
| Phase 1 | NCT07040982 | Dec 2026 → Jun 2028 expected | B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT07250087 | Jan 2026 → Nov 2029 expected | B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 1 | NCT03605277 | Nov 2018 → Mar 2019 | impaired renal function disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT03595917 | Jul 2018 → Nov 2026 expected | B-cell acute lymphoblastic leukemia, B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2), blast phase chronic myelogenous leukemia, BCR-ABL1 positive | Marlise Luskin, MD | Recruiting | No outcome recorded |
| Phase 1 | NCT02857868 | May 2016 → Jul 2017 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02081378 | Apr 2014 → Jun 2021 | B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2), chronic myeloid leukemia | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT07604233 | Nov 2026 → Jun 2031 expected | myeloid leukemia | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07387926 | Jul 2026 → Sep 2033 expected | B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2), acute lymphoblastic leukemia | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07136428 | Jul 2026 → Nov 2030 expected | HER2 positive breast carcinoma | Duke University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06308588 | Aug 2024 → May 2027 expected | acute lymphoblastic leukemia | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04925479 | Dec 2021 → Sep 2027 expected | Philadelphia-positive myelogenous leukemia | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 217 trials · 1 met primary | ||||||
| Phase 2 | NCT07354074 | Apr 2026 → Feb 2033 expected | Philadelphia-positive myelogenous leukemia, chronic myeloid leukemia | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT07538401 | Apr 2026 → Apr 2028 expected | chronic myeloid leukemia | University Health Network, Toronto | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06773936 | Apr 2026 → May 2029 expected | B-cell acute lymphoblastic leukemia, B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) | SWOG Cancer Research Network | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT07493408 | Mar 2026 → Dec 2035 expected | B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2), blast phase chronic myelogenous leukemia, BCR-ABL1 positive, disease related to hematopoietic stem cell transplant | The University of Hong Kong | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06409936 | Jun 2025 → Jun 2029 expected | chronic myeloid leukemia | GIMEMA Foundation | Recruiting | No outcome recorded |
| Phase 2 | NCT06514534 | Feb 2025 → Feb 2029 expected | chronic myeloid leukemia | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT06629584 | Feb 2025 → Dec 2026 expected | cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06368414 | Mar 2024 → Aug 2028 expected | chronic myeloid leukemia | Korean Society of Hematology | Recruiting | No outcome recorded |
| Phase 2 | NCT06236724 | Jan 2024 → Jul 2033 expected | chronic myeloid leukemia | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05384587 | Nov 2022 → Aug 2025 overdue | chronic myeloid leukemia | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05143840 | Apr 2022 → Feb 2032 expected | chronic myeloid leukemia | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase 2 | NCT04795427 | Dec 2021 → May 2023 | chronic myeloid leukemia | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT04838041 | Nov 2021 → Jun 2028 expected | chronic myeloid leukemia | Medical College of Wisconsin | Recruiting | No outcome recorded |
| Phase 2 | NCT04216563 | Jul 2020 → Mar 2025 | chronic myeloid leukemia | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT03906292 | Aug 2019 → Dec 2027 expected | chronic myeloid leukemia | University of Jena | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03874858 | Mar 2019 → Oct 2025 | chronic myeloid leukemia | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03578367 | Nov 2018 → Nov 2021 | chronic myeloid leukemia | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 36 trials · 2 met primary | ||||||
| Phase 3 | NCT05413915 | Nov 2023 → Jul 2025 | chronic myeloid leukemia | Sarit Assouline | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT05456191 | Nov 2022 → May 2025 overdue | Philadelphia-positive myelogenous leukemia | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04948333 | Oct 2021 → Mar 2024 | chronic myeloid leukemia | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT04971226 | Oct 2021 → Nov 2023 overdue | chronic myeloid leukemia | Novartis Pharmaceuticals | Active not recruiting | Met primary |
| Phase 3 | NCT04666259 | May 2021 → Jun 2023 | chronic myeloid leukemia | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03106779 | Oct 2017 → May 2020 | chronic myeloid leukemia | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT06427811 | Nov 2024 → Mar 2026 | Philadelphia-positive myelogenous leukemia | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT04877522 | Aug 2022 → Aug 2030 expected | chronic myeloid leukemia | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT07804901 Comparator | Jan 2027 → Dec 2030 expected | chronic myeloid leukemia | Prof. Dr. med. Andreas Hochhaus | Not yet recruiting | No outcome recorded |
| — | NCT04360005 Background | — | chronic myeloid leukemia | Novartis Pharmaceuticals | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 24
| Date | Issuer | Release |
|---|---|---|
| 2026-06-01 | Novartis Pharmaceuticals | Results Scemblix® continued to show superior efficacy and favorable safety and tolerability profile at week 144 in newly diagnosed CML novartis.com ↗
These results provide longer-term evidence that Scemblix demonstrated increasingly superior molecular responses at week 144 compared with established tyrosine kinase inhibitors (TKIs), strengthening confidence in its sustained response 1 . |
| 2026-05-13 | Mendus | Results Preclinical data presented at CIMT confirm combination potential of vididencel with current and upcoming CML treatments mendus.com ↗
The data demonstrate that vididencel can be combined with tyrosine kinase inhibitors (TKIs) used for the treatment of CML including asciminib, which belongs to a new class of TKIs known as allosteric inhibitors. |
| 2025-11-25 | Novartis Pharmaceuticals | Results Novartis data underscore pioneering scientific innovation in hematology and oncology at ASH and SABCS novartis.com ↗
Asciminib (ASC) demonstrates continued improvement in patient-reported outcomes (PROs) vs investigator-selected tyrosine kinase inhibitors (IS-TKIs) in newly diagnosed chronic myeloid leukemia (CML): ASC4FIRST week 96 analysis |
| 2025-10-17 | Novartis Pharmaceuticals | Regulatory Novartis Scemblix® receives positive CHMP opinion for the treatment of adults with newly diagnosed CML novartis.com ↗ |
| 2024-12-08 | Novartis Pharmaceuticals | Results Longer-term data for Novartis Scemblix® reinforce superior efficacy with favorable safety and tolerability profile in adults with newly diagnosed CML novartis.com ↗
Novartis today announced positive, longer-term results from the pivotal Phase III ASC4FIRST trial with Scemblix ® (asciminib) showing superior major molecular response (MMR) rates at week 96 1 . |
| 2024-10-29 | Novartis Pharmaceuticals | Regulatory Novartis Scemblix® FDA approved in newly diagnosed CML, offering superior efficacy, and favorable safety and tolerability profile novartis.com ↗
Novartis announced today that Scemblix ® (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). |
| 2024-07-29 | Novartis Pharmaceuticals | Regulatory Novartis Scemblix® granted FDA Priority Review for the treatment of adults with newly diagnosed CML novartis.com ↗ |
| 2024-05-31 | Novartis Pharmaceuticals | Results Novartis Scemblix® Phase III data first to show superior efficacy with a favorable safety and tolerability profile vs. standard-of-care TKIs in adults with newly diagnosed CML novartis.com ↗ |
| 2024-05-15 | Novartis Pharmaceuticals | Results Novartis highlights pioneering innovation in CML with data from Scemblix® Phase III ASC4FIRST study in newly diagnosed patients at ASCO and EHA novartis.com ↗
provides superior efficacy and excellent safety and tolerability vs tyrosine kinase inhibitors (TKI) in newly diagnosed chronic myeloid leukemia (CML) in the pivotal ASC4FIRST study |
| 2024-04-23 | Novartis Pharmaceuticals | Results Novartis delivers double-digit sales growth and core margin expansion in Q1; FY 2024 guidance raised novartis.com ↗
Phase III ASC4FIRST study met both primary endpoints |
| 2024-01-08 | Novartis Pharmaceuticals | Results Novartis Scemblix® shows superior major molecular response (MMR) rates vs. standard‐of‐care TKIs in Phase III trial for newly diagnosed patients with chronic myeloid leukemia novartis.com ↗ |
| 2023-11-20 | Novartis Pharmaceuticals | Results Novartis showcases significant data updates from Kisqali®, iptacopan and Scemblix® at SABCS and ASH novartis.com ↗
Sustained Efficacy and Safety with Asciminib (ASC) after Almost 4 Years of Median Follow-up from ASCEMBL |
| 2023-05-11 | Novartis Pharmaceuticals | Results Novartis to feature new PNH and CML scientific data from broad hematology portfolio at European Hematology Association Annual Meeting novartis.com ↗
Head-to-head data from Phase III ASCEMBL trial reaffirm Scemblix superiority over Bosulif* in patients with chronic myeloid leukemia (CML) in chronic phase, previously treated with two or more tyrosine kinase inhibitors |
| 2022-08-29 | Novartis Pharmaceuticals | Regulatory Novartis Scemblix®, with novel mechanism of action, approved by the European Commission for adult patients with chronic myeloid leukemia novartis.com ↗ |
| 2022-06-24 | Novartis Pharmaceuticals | Regulatory Novartis receives positive CHMP opinion for Scemblix®, a novel treatment for adult patients with chronic myeloid leukemia novartis.com ↗
Novartis today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization for Scemblix ® (asciminib) for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with two or more tyrosine kinase inhibitors (TKIs). |
| 2022-06-07 | Novartis Pharmaceuticals | Results Novartis Scemblix®, with novel mechanism of action, shows superior, long-term efficacy and consistent tolerability in 96-week follow-up of chronic myeloid leukemia trial novartis.com ↗
In this analysis, the proportion of patients in the Scemblix ® (asciminib) arm (n=157) who achieved a major molecular response (MMR) at 96 weeks was more than double that in the Bosulif ® (bosutinib) arm (n=76) (37.6% vs. 15.8% [ P =.001]), substantially increasing from previous analyses 1,2 . |
| 2021-12-11 | Novartis Pharmaceuticals | Results Novartis Scemblix® demonstrates sustained response rate in 48-week follow-up in patients with chronic myeloid leukemia novartis.com ↗
The proportion of patients treated with Scemblix who experienced adverse reactions leading to discontinuation was more than three times lower than those in the Bosulif arm (7.1% vs. 25%) 1 . |
| 2021-10-29 | Novartis Pharmaceuticals | Regulatory FDA approves Novartis Scemblix® (asciminib), with novel mechanism of action for the treatment of chronic myeloid leukemia novartis.com ↗
Novartis announced today that the US Food and Drug Administration (FDA) approved Scemblix ® (asciminib) for the treatment of chronic myeloid leukemia (CML) in two distinct indications. |
| 2021-02-08 | Novartis Pharmaceuticals | Regulatory Novartis receives FDA Breakthrough Therapy designations for investigational STAMP inhibitor asciminib (ABL001) in chronic myeloid leukemia novartis.com ↗
Asciminib was also granted BTD for the treatment of adult patients with Ph+ CML in CP harboring the T315I mutation. |
| 2020-12-08 | Novartis Pharmaceuticals | Results Novartis investigational STAMP inhibitor asciminib (ABL001) shows superior MMR rate to Bosulif®* in chronic myeloid leukemia trial novartis.com ↗
At 24 weeks, asciminib nearly doubled the major molecular response (MMR) rate compared to Bosulif ® (bosutinib)* , in patients resistant to , or intolerant of , at least two prior tyrosine kinase inhibitor ( TKI ) therapies |
| 2020-08-26 | Novartis Pharmaceuticals | Results Novartis investigational novel STAMP inhibitor asciminib (ABL001) meets primary endpoint of Phase III chronic myeloid leukemia study novartis.com ↗
At primary analysis, ASCEMBL met its primary endpoint of significant superiority in major molecular response rate at 24 weeks for asciminib (ABL001) vs. bosutinib in patients previously treated with two or more tyrosine-kinase inhibitors (TKIs) 1 |
| 2019-06-14 | Novartis Pharmaceuticals | Results Novartis continues to innovate in CML with long-term treatment-free remission results following Tasigna® use and promising combination data with investigational compound asciminib (ABL001) novartis.com ↗
Separate data demonstrate promising results for asciminib (ABL001), an investigational allosteric BCR-ABL inhibitor, in combination with three different tyrosine kinase inhibitors (TKIs) in heavily pre-treated Ph+ CML-CP patients. |
| 2016-11-16 | Novartis Pharmaceuticals | Results Novartis data at ASH and SABCS showcase latest innovations in development for patients with blood disorders and breast cancer novartis.com ↗
ABL001 Expanded Phase I Study Update of ABL001, a Potent, Allosteric Inhibitor of BCR-ABL, Reveals Significant and Durable Responses in Patients with CML-Chronic Phase with Failure of Prior TKI Therapy |
| 2015-11-30 | Novartis Pharmaceuticals | Results Novartis highlights clinical advances at ASH 2015, underscoring leadership in hematology research novartis.com ↗
ABL001, a Potent, Allosteric Inhibitor of BCR-ABL, Exhibits Safety and Promising Single- Agent Activity in a Phase I Study of Patients with CML with Failure of Prior TKI Therapy |
All press releases naming this drug 27 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Asciminib | “a drug called Asciminib (having different way of action), used either by itself or with another drug called Dasatinib” NCT07538401 ↗34“Asciminib 80mg QD (in combination with Nilotinib or Dasatinib) or Asciminib 60mg QD (in combination with Imatinib)” NCT07493408 ↗ “Asciminib 80mg QD ist the usual standard of care therapy for CML” NCT07804901 ↗ “Asciminib, Dasatinib, Prednisone, and Methotrexate” NCT06773936 ↗ |
| Known as | ABL001 | “The drug asciminib (ABL001, Novartis), an allosteric ABL kinase inhibitor currently FDA approved for treatment of CML.” NCT07136428 ↗5“Study of Asciminib (ABL001) Monotherapy” NCT04666259 ↗ |
| Known as | ABL001 (asciminib) | “ABL001 (asciminib)” NCT03578367 ↗ |
| Known as | ASC | “Asciminib (ASC) add-on” NCT07493408 ↗ |
| Known as | Scemblix | “which is marketed under the brand name Scemblix®” NCT06514534 ↗ |
| Action | Inhibit | “Asciminib is an allosteric inhibitor that binds a myristoyl site of the BCR-ABL1 protein” PMID 31826340 ↗ Dec 2019 |
| Route | Oral | “Asciminib was be administered orally in a dose escalation schedule.” NCT02081378 ↗ |
| Target | ABL1 | “Asciminib targets the BCR::ABL1 myristoyl pocket” PMID 38755421 ↗ May 2024 |