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  1. pharmadog
  2. ›drugs
  3. ›Venclexta
drug · small molecule
save

venetoclax

Marketedupdated 5mo ago
by $ABBV AbbVie Inc.🔗 ChEMBL
Approved
community read0 votes

🐶 often sniffed alongside

top 7
  • drugVENCLEXTA82 co-mentions · 22 sources
  • tagApproval80 co-mentions · 20 sources
  • tagSmall Molecule40 co-mentions · 20 sources
  • tagOncology2 co-mentions · 2 sources
  • tagHematology2 co-mentions · 1 sources
  • companyInstitute of Hematology and Blood Diseases Hospital1 co-mentions · 1 sources
  • tagAML1 co-mentions · 1 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for chronic lymphocytic leukemia and neoplasm and 38 investigational indications.

targets

Apoptosis regulator Bcl-2

all catalysts(22)

approval · 20
Apr 11, 2016
approval
$ABBV285.42+0.71%
11y ago
VENCLEXTA (VENETOCLAX) — FDA approval
venetoclax
→
Dec 20, 2017
approval
$ABBV285.42+0.71%
9y ago
VENCLEXTA (VENETOCLAX) — FDA approval
venetoclax
→
Jun 8, 2018
approval
$ABBV285.42+0.71%
8y ago
VENCLEXTA (VENETOCLAX) — FDA approval
venetoclax
→
Jun 8, 2018
approval
$ABBV285.42+0.71%
8y ago
VENCLEXTA (VENETOCLAX) — FDA approval
venetoclax
→
Sep 7, 2018
approval
$ABBV285.42+0.71%
8y ago
VENCLEXTA (VENETOCLAX) — FDA approval
venetoclax
→
Sep 7, 2018
approval
$ABBV285.42+0.71%
8y ago
VENCLEXTA (VENETOCLAX) — FDA approval
venetoclax
→
Nov 21, 2018
approval
$ABBV285.42+0.71%
8y ago
VENCLEXTA (VENETOCLAX) — FDA approval
venetoclax
→
May 15, 2019
approval
$ABBV285.42+0.71%
7y ago
VENCLEXTA (VENETOCLAX) — FDA approval
venetoclax
→
Jul 25, 2019
approval
$ABBV285.42+0.71%
7y ago
VENCLEXTA (VENETOCLAX) — FDA approval
venetoclax
→
Jul 25, 2019
approval
$ABBV285.42+0.71%
7y ago
VENCLEXTA (VENETOCLAX) — FDA approval
venetoclax
→
Jul 25, 2019
approval
$ABBV285.42+0.71%
7y ago
VENCLEXTA (VENETOCLAX) — FDA approval
venetoclax
→
May 29, 2020
approval
$ABBV285.42+0.71%
6y ago
VENCLEXTA (VENETOCLAX) — FDA approval
venetoclax
→
Jun 12, 2020
approval
$ABBV285.42+0.71%
6y ago
VENCLEXTA (VENETOCLAX) — FDA approval
venetoclax
→
Oct 16, 2020
approval
$ABBV285.42+0.71%
6y ago
VENCLEXTA (VENETOCLAX) — FDA approval
venetoclax
→
Oct 16, 2020
approval
$ABBV285.42+0.71%
6y ago
VENCLEXTA (VENETOCLAX) — FDA approval
venetoclax
→
Nov 19, 2020
approval
$ABBV285.42+0.71%
6y ago
VENCLEXTA (VENETOCLAX) — FDA approval
venetoclax
→
Oct 4, 2021
approval
$ABBV285.42+0.71%
5y ago
VENCLEXTA (VENETOCLAX) — FDA approval
venetoclax
→
Oct 22, 2021
approval
$ABBV285.42+0.71%
5y ago
VENCLEXTA (VENETOCLAX) — FDA approval
venetoclax
→
Jun 15, 2022
approval
$ABBV285.42+0.71%
4y ago
VENCLEXTA (VENETOCLAX) — FDA approval
venetoclax
→
Feb 19, 2026
approval
$ABBV285.42+0.71%
8mo ago
VENCLEXTA (VENETOCLAX) — FDA approval
venetoclax
→
phase 1 2 completion · 1
Apr 30, 2026
phase 1 2 completion
$ABBV285.42+0.71%
6mo ago
AbbVie Inc — venetoclax (Phase I/II Trial Completion)
venetoclax
→
phase 3 initiation · 1
Apr 29, 2026
phase 3 initiation
6mo ago
Institute of Hematology and Blood Diseases Hospital — venetoclax (Phase III Trial Initiation)
venetoclax
→
view all 22 catalysts →

Trials studying venetoclax

  • phase2Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclaxactive not recruitingn=35
  • phase1Danvatirsen Monotherapy Followed by Combination With Venetoclax in Relapsed/Refractory MDS & AMLrecruitingn=38
  • phase3Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)active not recruitingn=652
  • phase2Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)active not recruitingn=101
  • phase1A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemiarecruitingn=332
  • phase3A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)recruitingn=316
  • phase2AZA + Venetoclax as Maintenance Therapy in Patients With AML in Remissionactive not recruitingn=50
  • phase3A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML)recruitingn=660

Patent cliff

source: FDA Orange Book
first barrier falls
May 26, 2030
~3.6 years out

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

patents (30)

  • Sep 6, 2033method-of-use (U-3114)US 10993942
  • Sep 6, 2033method-of-use (U-3114)US 10993942
  • Sep 6, 2033method-of-use (U-3114)US 10993942
  • Sep 6, 2033method-of-use (U-3223)US 11110087
  • Sep 6, 2033method-of-use (U-3223)US 11110087
  • Sep 6, 2033method-of-use (U-3223)US 11110087
  • Sep 6, 2033method-of-use (U-3412)US 11413282
  • Sep 6, 2033method-of-use (U-3412)US 11413282
  • Sep 6, 2033method-of-use (U-3412)US 11413282
  • Sep 6, 2033method-of-use (U-3548)US 11590128
  • Sep 6, 2033method-of-use (U-3548)US 11590128
  • Sep 6, 2033method-of-use (U-3548)US 11590128
  • Sep 6, 2033method-of-use (U-2538)US 9539251
  • Sep 6, 2033method-of-use (U-2538)US 9539251
  • Sep 6, 2033method-of-use (U-2538)US 9539251
  • May 23, 2032formulationUS 11369599
  • May 23, 2032formulationUS 11369599
  • May 23, 2032formulationUS 11369599
  • Jan 29, 2032compositionUS 8722657
  • Jan 29, 2032compositionUS 8722657
  • Jan 29, 2032compositionUS 8722657
  • Nov 21, 2031compositionUS 10730873
  • Nov 21, 2031compositionUS 10730873
  • Nov 21, 2031compositionUS 10730873
  • Jun 27, 2031compositionUS 85463994.7y
  • Jun 27, 2031compositionUS 85463994.7y
  • Jun 27, 2031compositionUS 85463994.7y
  • May 26, 2030method-of-use (U-2323)US 91749823.6y
  • May 26, 2030method-of-use (U-2446)US 91749823.6y
  • May 26, 2030method-of-use (U-2445)US 91749823.6y

FDA exclusivities (3)

  • May 15, 2026ODE-239Orphan Drug (7y)
  • May 15, 2026ODE-239Orphan Drug (7y)
  • May 15, 2026ODE-239Orphan Drug (7y)

News(10)

  • BMS dumps $100M Orum degrader-antibody conjugate after glimpsing phase 1 data
    Bristol Myers Squibb has axed the degrader-antibody conjugate it bought from Orum Therapeutics for $100 million, walking away from the asset after seeing phase 1 data.
    fiercebiotech · 1mo ago
  • Chutes & Ladders—Legend CEO departs without successor in place
    Legend Biotech CEO Ying Huang, Ph.D., has left the company suddenly, without a predecessor in place. Huang was elevated from CFO to CEO in 2020 after a Chinese customs investigation was opened on f…
    fiercebiotech · 2mo ago
  • Sarepta names former AbbVie R&D exec Michael Severino as next CEO
    After leaving Tessera Therapeutics earlier this month, Michael Severino will take over Sarepta Therapeutics as the biotech awaits two key regulatory decisions in Duchenne muscular dystrophy.
    biospace · 2mo ago
  • Biotech leaders campaign for Pazdur; Takeda to lay off 4,500 workers
    Hundreds of executives and investors are pushing for Rick Pazdur to be the next FDA commissioner. Elsewhere, Takeda detailed its latest restructuring and Alumis is discarding a once-highly touted i…
    biopharma_dive · 5mo ago
  • BeOne’s next-gen BCL2 inhibitor wins FDA approval, taking aim at Venclexta
    BeOne Medicines has clinched an accelerated approval for its drug sonrotoclax in mantle cell lymphoma (MCL), marking the start of its bid to challenge AbbVie and Roche's Venclexta across a range of…
    endpoints · 5mo ago
  • Dr Loghavi on the Significance of Updated WHO Diagnostic Criteria for AML in Clinical Practice
    Sanam Loghavi, MD, discusses updated WHO diagnostic criteria for acute myeloid leukemia and its significance for diagnoses and treatment selection.
    onclive · 5mo ago
  • FDA Approves Decitabine/Cedazuridine Plus Venetoclax in Newly Diagnosed AML
    The FDA has approved oral decitabine/cedazuridine plus venetoclax for newly diagnosed AML unfit for intensive chemo, based on phase 2 ASCERTAIN-V data.
    onclive · 5mo ago
  • FDA Approves Sonrotoclax for Relapsed/Refractory Mantle Cell Lymphoma
    The FDA granted accelerated approval to sonrotoclax for relapsed/refractory mantle cell lymphoma after at least 2 lines of systemic therapy.
    onclive · 5mo ago
  • Dr Dinardo on the FDA Approval of Decitabine/Cedazuridine Plus Venetoclax in AML
    Courtney D. DiNardo, MD, MSCE, discusses the FDA approval of decitabine/cedazuridine plus venetoclax in acute myeloid leukemia.
    onclive · 5mo ago
  • Combination and Sequencing Strategies in Metastatic Castration-Resistant Prostate Cancer
    Dr. Pedro Barata and Dr. Johann De Bono discuss ongoing questions surrounding combination approaches and optimal sequencing strategies for radiopharmaceutical therapies in metastatic castration-res…
    onclive · 5mo ago
view all news mentions →
brand
Venclexta
trade names
Venclexta, Venclyxto
generic
venetoclax
MOA
Apoptosis regulator Bcl-2 inhibitor
indication
Mantle Cell Lymphoma
phase
marketed
Data sources
openFDA · ClinicalTrials.gov · OpenTargets
last refreshed 3h ago
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