Drugs / Asciminib
Asciminib
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| — | NCT04360005 Background | — | chronic myeloid leukemia | Novartis Pharmaceuticals | Available | No outcome recorded |
Press releases naming this drug 21 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-01 | Novartis Pharmaceuticals | Scemblix® continued to show superior efficacy and favorable safety and tolerability profile at week 144 in newly diagnosed CML novartis.com ↗ |
| 2025-10-17 | Novartis Pharmaceuticals | Novartis Scemblix® receives positive CHMP opinion for the treatment of adults with newly diagnosed CML novartis.com ↗ |
| 2024-12-08 | Novartis Pharmaceuticals | Longer-term data for Novartis Scemblix® reinforce superior efficacy with favorable safety and tolerability profile in adults with newly diagnosed CML novartis.com ↗ |
| 2024-11-25 | Novartis Pharmaceuticals | Novartis highlights new 96-week results from Phase III Scemblix® ASC4FIRST trial at ASH and late-breaking analysis from Phase III Kisqali® NATALEE trial at SABCS novartis.com ↗ |
| 2024-10-29 | Novartis Pharmaceuticals | Novartis Scemblix® FDA approved in newly diagnosed CML, offering superior efficacy, and favorable safety and tolerability profile novartis.com ↗ |
| 2024-07-29 | Novartis Pharmaceuticals | Novartis Scemblix® granted FDA Priority Review for the treatment of adults with newly diagnosed CML novartis.com ↗ |
| 2024-05-31 | Novartis Pharmaceuticals | 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 | Novartis highlights pioneering innovation in CML with data from Scemblix® Phase III ASC4FIRST study in newly diagnosed patients at ASCO and EHA novartis.com ↗ |
| 2024-01-08 | Novartis Pharmaceuticals | 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 | Novartis showcases significant data updates from Kisqali®, iptacopan and Scemblix® at SABCS and ASH novartis.com ↗ |
| 2022-11-22 | Novartis Pharmaceuticals | Novartis highlights scientific advances with Kisqali, iptacopan, Scemblix and YTB323 data at SABCS and ASH novartis.com ↗ |
| 2022-08-29 | Novartis Pharmaceuticals | 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 | Novartis receives positive CHMP opinion for Scemblix®, a novel treatment for adult patients with chronic myeloid leukemia novartis.com ↗ |
| 2022-06-07 | Novartis Pharmaceuticals | 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 ↗ |
| 2021-12-11 | Novartis Pharmaceuticals | Novartis Scemblix® demonstrates sustained response rate in 48-week follow-up in patients with chronic myeloid leukemia novartis.com ↗ |
| 2021-11-04 | Novartis Pharmaceuticals | New data at ASH spotlight Novartis recently approved Scemblix®, next-generation CAR-T platform and expanding hematology portfolio novartis.com ↗ |
| 2021-10-29 | Novartis Pharmaceuticals | FDA approves Novartis Scemblix® (asciminib), with novel mechanism of action for the treatment of chronic myeloid leukemia novartis.com ↗ |
| 2021-02-08 | Novartis Pharmaceuticals | Novartis receives FDA Breakthrough Therapy designations for investigational STAMP inhibitor asciminib (ABL001) in chronic myeloid leukemia novartis.com ↗ |
| 2020-12-08 | Novartis Pharmaceuticals | Novartis investigational STAMP inhibitor asciminib (ABL001) shows superior MMR rate to Bosulif®* in chronic myeloid leukemia trial novartis.com ↗ |
| 2020-08-26 | Novartis Pharmaceuticals | Novartis investigational novel STAMP inhibitor asciminib (ABL001) meets primary endpoint of Phase III chronic myeloid leukemia study novartis.com ↗ |
| 2019-06-14 | Novartis Pharmaceuticals | 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 ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 40 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 ↗33“Asciminib 80mg QD (in combination with Nilotinib or Dasatinib) or Asciminib 60mg QD (in combination with Imatinib)” NCT07493408 ↗ “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 |