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  1. pharmadog
  2. ›drugs
  3. ›Scemblix
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asciminib hydrochloride

Marketedupdated 3mo ago
by $NVS NOVARTIS AG
Approved
community read0 votes

🐶 often sniffed alongside

top 7
  • drugSCEMBLIX46 co-mentions · 13 sources
  • tagApproval44 co-mentions · 11 sources
  • tagSmall Molecule22 co-mentions · 11 sources
  • tagOncology3 co-mentions · 2 sources
  • company$NVSNOVARTIS AG1 co-mentions · 1 sources
  • company$NVSEFNOVARTIS AG1 co-mentions · 1 sources
  • companyWashington University School of Medicine1 co-mentions · 1 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for blast phase chronic myelogenous leukemia, bcr-abl1 positive and chronic myelogenous leukemia.

all catalysts(13)

approval · 11
Oct 29, 2021
approval
$NVS150.88-0.55%
5y ago
SCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approval
asciminib hydrochloride
→
Oct 29, 2021
approval
$NVS150.88-0.55%
5y ago
SCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approval
asciminib hydrochloride
→
Oct 12, 2022
approval
$NVS150.88-0.55%
4y ago
SCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approval
asciminib hydrochloride
→
Jun 26, 2023
approval
$NVS150.88-0.55%
3y ago
SCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approval
asciminib hydrochloride
→
Nov 8, 2023
approval
$NVS150.88-0.55%
3y ago
SCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approval
asciminib hydrochloride
→
Jun 18, 2024
approval
$NVS150.88-0.55%
2y ago
SCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approval
asciminib hydrochloride
→
Aug 7, 2024
approval
$NVS150.88-0.55%
2y ago
SCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approval
asciminib hydrochloride
→
Oct 29, 2024
approval
$NVS150.88-0.55%
2y ago
SCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approval
asciminib hydrochloride
→
Oct 29, 2024
approval
$NVS150.88-0.55%
2y ago
SCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approval
asciminib hydrochloride
→
Oct 2, 2025
approval
$NVS150.88-0.55%
11mo ago
SCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approval
asciminib hydrochloride
→
Nov 25, 2025
approval
$NVS150.88-0.55%
9mo ago
SCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approval
asciminib hydrochloride
→
phase 0 trial initiation · 1
Apr 30, 2026
phase 0 trial initiation
4mo ago
Washington University School of Medicine — asciminib hydrochloride (Phase 0 Trial Initiation)
asciminib hydrochloride
→
phase 2 initiation · 1
Apr 25, 2026
phase 2 initiation
$NVS150.88-0.55%
4mo ago
Novartis AG — asciminib hydrochloride (Phase II Trial Initiation)
asciminib hydrochloride
→
view all 13 catalysts →

Patent cliff

source: FDA Orange Book
first barrier falls
Oct 29, 2026
74 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (12)

  • May 17, 2040method-of-use (U-1374)US 12252479
  • May 17, 2040method-of-use (U-1374)US 12252479
  • May 17, 2040method-of-use (U-1374)US 12252479
  • May 14, 2040compositionUS 11407735
  • May 14, 2040compositionUS 11407735
  • May 14, 2040compositionUS 11407735
  • May 14, 2040formulationUS 12252478
  • May 14, 2040formulationUS 12252478
  • May 14, 2040formulationUS 12252478
  • Oct 29, 2035compositionUS 8829195
  • Oct 29, 2035compositionUS 8829195
  • Oct 29, 2035compositionUS 8829195

FDA exclusivities (19)

  • Oct 29, 2031ODE-499Orphan Drug (7y)
  • Oct 29, 2031ODE-499Orphan Drug (7y)
  • Oct 29, 2031ODE-500Orphan Drug (7y)
  • Oct 29, 2031ODE-500Orphan Drug (7y)
  • Oct 29, 2028ODE-382Orphan Drug (7y)2.2y
  • Oct 29, 2028ODE-382Orphan Drug (7y)2.2y
  • Oct 29, 2028ODE-381Orphan Drug (7y)2.2y
  • Oct 29, 2028ODE-381Orphan Drug (7y)2.2y
  • Oct 29, 2028ODE*ODE*2.2y
  • Oct 2, 2028M-318Method (3y)2.1y
  • Oct 2, 2028M-318Method (3y)2.1y
  • Oct 2, 2028M-318Method (3y)2.1y
  • Oct 29, 2027I-953Indication (3y)1.2y
  • Oct 29, 2027I-954Indication (3y)1.2y
  • Oct 29, 2027I-954Indication (3y)1.2y
  • Oct 29, 2027I-953Indication (3y)1.2y
  • Oct 29, 2026NCENew Chemical Entity (5y)74d
  • Oct 29, 2026NCENew Chemical Entity (5y)74d
  • Oct 29, 2026NCENew Chemical Entity (5y)74d

News(3)

  • Novartis climbs on upbeat drug sales as key readouts loom
    A return to quarterly sales growth boosted shares higher on Tuesday, though a handful of coming study results will have a bigger impact on the company’s long-term outlook.
    biopharma_dive · 24d ago
  • J&J looks to widen Imaavy’s use; $300M backs rare disease drug launch
    New data suggest Imaavy could be an effective treatment for autoimmune anemia. Elsewhere, Enliven detailed data for a Merck leukemia rival and MBX hyperparathyroidism drug hit its goal.
    biopharma_dive · 2mo ago
  • Merck still sees ‘compelling’ outlook for Terns leukemia drug
    Despite updated study data that suggest Terns’ treatment may be less differentiated, company executives claimed Thursday that it still could be an important step forward in care.
    biopharma_dive · 3mo ago
brand
Scemblix
generic
asciminib hydrochloride
MOA
12.1 Mechanism of Action Asciminib is an ABL/BCR-ABL1 tyrosine kinase inhibitor. Asciminib inhibits the ABL1 kinase activity of the BCR::ABL1 fusion protein, by binding to the ABL myristoyl pocket. In studies conducted in vitro or in animal models of CML, asciminib showed activity against wild-type BCR::ABL1 and several mutant forms of the kinase, including the T315I mutation.
indication
Chronic Myelocytic Leukemia (CML, Chronic Myeloid Leukemia)
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 9m ago
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