Synopsis
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DRUG PRODUCT COMPOSITIONS
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1. 4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-n-((3-nitro-4-((tetrahydro-2h-pyran-4-ylmethyl)amino)phenyl)sulfonyl)-2-(1h-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide
2. Abt-199
3. Benzamide, 4-(4-((2-(4-chlorophenyl)-4,4-dimethyl-1-cyclohexen-1-yl)methyl)-1-piperazinyl)-n-((3-nitro-4-(((tetrahydro-2h-pyran-4-yl)methyl)amino)phenyl)sulfonyl)-2-(1h-pyrrolo(2,3-b)pyridin-5-yloxy)-
4. Gdc-0199
5. Rg-7601
6. Rg7601
7. Venclexta
1. 1257044-40-8
2. Abt-199
3. Venclexta
4. Gdc-0199
5. Abt199
6. Abt 199
7. Rg7601
8. Venetoclax (abt199)
9. Gdc 0199
10. Rg-7601
11. Venetoclax; Abt-199
12. 4-[4-[[2-(4-chlorophenyl)-4,4-dimethylcyclohexen-1-yl]methyl]piperazin-1-yl]-n-[3-nitro-4-(oxan-4-ylmethylamino)phenyl]sulfonyl-2-(1h-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide
13. Venetoclax (abt-199)
14. N54aic43pw
15. Abt-199 (gdc-0199)
16. 2-(1h-pyrrolo[2,3-b]pyridin-5-yloxy)-4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-enyl)methyl)piperazin-1-yl)-n-(3-nitro-4-((tetrahydro-2h-pyran-4-yl)methy
17. 4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-n-((3-nitro-4-((tetrahydro-2h-pyran-4-ylmethyl)amino)phenyl)sulfonyl)-2-(1h-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide
18. 4-[4-[[2-(4-chlorophenyl)-4,4-dimethyl-1-cyclohexen-1-yl]methyl]-1-piperazinyl]-n-[[3-nitro-4-[[(tetrahydro-2h-pyran-4-yl)methyl]amino]phenyl]sulfonyl]-2-(1h-pyrrolo[2,3-b]pyridin-5-yloxy)-benzamide
19. Benzamide, 4-(4-((2-(4-chlorophenyl)-4,4-dimethyl-1-cyclohexen-1-yl)methyl)-1-piperazinyl)-n-((3-nitro-4-(((tetrahydro-2h-pyran-4-yl)methyl)amino)phenyl)sulfonyl)-2-(1h-pyrrolo(2,3-b)pyridin-5-yloxy)-
20. Venclyxto
21. Bdbm189459
22. Unii-n54aic43pw
23. 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-n-({3-nitro-4-[(oxan-4-ylmethyl)amino]benzene}sulfonyl)-2-{1h-pyrrolo[2,3-b]pyridin-5-yloxy}benzamide
24. 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-n-({3-nitro-4-[(tetrahydro-2h-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1h-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide
25. 4-{4-[(4'-chloro-5,5-dimethyl[3,4,5,6-tetrahydro[1,1'-biphenyl]]-2-yl)methyl]piperazin-1-yl}-n-(3-nitro-4-{[(oxan-4-yl)methyl]amino}benzene-1-sulfonyl)-2-[(1h-pyrrolo[2,3-b]pyridin-5-yl)oxy]benzamide
26. Venetoclax [usan:inn]
27. Venclexta (tn)
28. Benzamide, 4-[4-[[2-(4-chlorophenyl)-4,4-dimethyl-1-cyclohexen-1-yl]methyl]-1-piperazinyl]-n-[[3-nitro-4-[[(tetrahydro-2h-pyran-4-yl)methyl]amino]phenyl]sulfonyl]-2-(1h-pyrrolo[2,3-b]pyridin-5-yloxy)-
29. Venetoclax [mi]
30. Venetoclax(abt-199)
31. Venetoclax [inn]
32. Venetoclax [jan]
33. Venetoclax [usan]
34. Venetoclax [who-dd]
35. Mls006010298
36. Schembl523816
37. Venetoclax (jan/usan/inn)
38. Amy343
39. Gtpl8318
40. Chembl3137309
41. Schembl19236295
42. Venetoclax [orange Book]
43. Bdbm60828
44. Dtxsid30154863
45. Ex-a168
46. Chebi:133021
47. Hms3653j06
48. Hms3745e07
49. Bcp06811
50. Bdbm50162774
51. Mfcd23160052
52. Nsc766270
53. Akos025289539
54. Zinc150338755
55. Ccg-270543
56. Cs-1155
57. Db11581
58. Ks-1470
59. Nsc-766270
60. Sb16499
61. Ncgc00345789-01
62. Ncgc00345789-05
63. Ncgc00345789-10
64. Ncgc00345789-11
65. Ac-28754
66. Da-35360
67. Hy-15531
68. Smr004701366
69. Ft-0699586
70. S8048
71. Sw219672-1
72. J3.516.625d
73. D10679
74. Us9174982, 5
75. A850921
76. Us9174982, 369
77. J-005269
78. Q23671272
79. 2-((1h-pyrrolo[2,3-b]pyridin-5-yl)oxy)-4-(4-((4'-chloro-5,5-dimethyl-3,4,5,6-tetrahydro-[1,1'-biphenyl]-2-yl)methyl)piperazin-1-yl)-n-((3-nitro-4-(((tetrahydro-2h-pyran-4-yl)methyl)amino)phenyl)sulfonyl)benzamide
80. 4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-n-((3-nitro-4-((tetrahydro-2hpyran-4-ylmethyl) Amino)phenyl)sulfonyl)-2-(1h-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide
81. 4-[4-[[2-(4-chlorophenyl)-4,4-dimethyl-1-cyclohexen-1-yl]methyl]-1-piperazinyl]-n-[[3-nitro-4-[[(tetrahydro-2h-pyran-4-yl)methyl]amino]phenyl]sulfonyl]-2-(1h-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide
82. 4-[4-[[2-(4-chlorophenyl)-4,4-dimethyl-cyclohexen-1-yl]methyl]piperazin-1-yl]-n-[3-nitro-4-(tetrahydropyran-4-ylmethylamino)phenyl]sulfonyl-2-(1h-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide
83. 4-{4-[(4'-chloro-5,5-dimethyl[3,4,5,6-tetrahydro[1,1'-biphenyl]]-2-yl)methyl]piperazin-1-yl}-n-[(3-nitro-4-{[(oxan-4-yl
Molecular Weight | 868.4 g/mol |
---|---|
Molecular Formula | C45H50ClN7O7S |
XLogP3 | 8.2 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 11 |
Rotatable Bond Count | 12 |
Exact Mass | 867.3180958 g/mol |
Monoisotopic Mass | 867.3180958 g/mol |
Topological Polar Surface Area | 183 Ų |
Heavy Atom Count | 61 |
Formal Charge | 0 |
Complexity | 1640 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
A BCL-2 inhibitor indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.
FDA Label
Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5. 1).
Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
Venclyxto monotherapy is indicated for the treatment of CLL:
- in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B cell receptor pathway inhibitor, or
- in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.
Venetoclax induces rapid and potent onset apoptosis of CLL cells, powerful enough to act within 24h and to lead to tumor lysis syndrome,,. Selective targeting of BCL2 with venetoclax has demonstrated a manageable safety profile and has been shown to induce significant response in patients with relapsed CLL (chronic lymphocytic leukemia) or SLL (small lymphocytic leukemia), including patients with poor prognostic features. This drug is not expected to have a significant impact on the cardiac QT interval. Venetoclax has demonstrated efficacy in various types of lymphoid malignancies, including relapsed/ refractory CLL harboring deletion 17p, with an overall response rate of approximately 80%.
Antineoplastic Agents
Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)
L01XX52
L - Antineoplastic and immunomodulating agents
L01 - Antineoplastic agents
L01X - Other antineoplastic agents
L01XX - Other antineoplastic agents
L01XX52 - Venetoclax
Absorption
Following several oral administrations after a meal, the maximum plasma concentration of venetoclax was reached 5-8 hours after the dose. Venetoclax steady state AUC (area under the curve) increased proportionally over the dose range of 150-800 mg. After a low-fat meal, venetoclax mean ( standard deviation) steady-state Cmax was 2.1 1.1 g/mL and AUC0-24 was 32.8 16.9 gh/mL at the 400 mg once daily dose. When compared with the fasted state, venetoclax exposure increased by 3.4 times when ingested with a low-fat meal and 5.2 times with a high-fat meal. When comparing low versus high fat, the Cmax and AUC were both increased by 50% when ingested with a high-fat meal. The FDA label indicataes that venetoclax should be taken with food,.
Route of Elimination
After single oral administration of 200 mg radiolabeled [14C]-venetoclax dose to healthy subjects, >99.9% of the dose was found in feces and <0.1% of the dose was excreted in urine within 9 days, suggesting that hepatic elimination is responsible for the clearance of venetoclax from systemic circulation. Unchanged venetoclax accounted for 20.8% of the radioactive dose excreted in feces.
Volume of Distribution
The population estimate for apparent volume of distribution (Vdss/F) of venetoclax ranged from 256-321 L.
Clearance
Mainly hepatic.
In vitro studies demonstrated that venetoclax is predominantly metabolized as a substrate of CYP3A4/5,,.
The half-life of venetoclax is reported to be 19-26 hours, after administration of a single 50-mg dose,.
Proteins in the B cell CLL/lymphoma 2 (BCL-2) family are necessary regulators of the apoptotic (anti-cell programmed death) process. This family comprises proapoptotic and prosurvival proteins for various cells. Cancer cells evade apoptosis by inhibiting programmed cell death (apoptosis). The therapeutic potential of directly inhibiting prosurvival proteins was unveiled with the development of navitoclax, a selective inhibitor of both BCL-2 and BCL-2-like 1 (BCL-X(L)), which has demonstrated clinical efficacy in some BCL-2-dependent hematological cancers. Selective inhibition of BCL-2 by venetoclax, sparing BCL-xL enables therapeutic induction of apoptosis without the negative effect of thrombocytopenia,. Venetoclax helps restore the process of apoptosis by binding directly to the BCL-2 protein, displacing pro-apoptotic proteins, leading to mitochondrial outer membrane permeabilization and the activation of caspase enzymes. In nonclinical studies, venetoclax has shown cytotoxic activity in tumor cells that overexpress BCL-2.
Registrant Name : AbbVie Korea Inc.
Registration Date : 2020-03-26
Registration Number : Su325-10-ND
Manufacturer Name : AbbVie Ireland NL BV
Manufacturer Address : Manorhamilton Road Sligo, Ireland
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-02-13
Pay. Date : 2020-01-21
DMF Number : 33669
Submission : 2019-03-29
Status : Active
Type : II
NDC Package Code : 71796-008
Start Marketing Date : 2019-03-29
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34250
Submission : 2019-11-15
Status : Active
Type : II
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33627
Submission : 2019-03-26
Status : Active
Type : II
About the Company : Lebsa is an innovative European laboratory that specializes in the synthesis, manufacture and commercialization of APIs with a focus on niche products. With a track record spanning...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
About the Company : Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its produc...
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
About the Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cyto...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
About the Company : Changzhou Pharmaceutical Factory (CPF) is a subsidiary company of Shanghai Pharma Holdings Co., Ltd., It is headquartered in Changzhou, Jiangsu Province, China. The company was fou...
About the Company : NATCO PHARMA LIMITED was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. With a modest beginning of operations as a single unit with 20 e...
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Details:
Venetoclax, a first-in-class BCL-2 inhibitor, functions by selectively targeting cancer cells in the blood and bone marrow. It is indicated for AML & CLL.
Lead Product(s): Venetoclax
Therapeutic Area: Oncology Brand Name: Venclexta
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 21, 2025
Lead Product(s) : Venetoclax
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
AbbVie Introduces Venetoclax in India for Treatment of AML and CLL
Details : Venetoclax, a first-in-class BCL-2 inhibitor, functions by selectively targeting cancer cells in the blood and bone marrow. It is indicated for AML & CLL.
Product Name : Venclexta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 21, 2025
Details:
VENCLEXTA®/VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis.
Lead Product(s): Venetoclax,Azacitidine
Therapeutic Area: Oncology Brand Name: Venclexta
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 05, 2022
Lead Product(s) : Venetoclax,Azacitidine
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
AbbVie to Showcase Oncology Portfolio and Pipeline During the 2022 ASCO and EHA Annual Congresses
Details : VENCLEXTA®/VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, c...
Product Name : Venclexta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 05, 2022
Details:
Data shows that after more than five years of median follow-up (65.4 months), PFS remained significantly superior among patients treated with the VENCLEXTA (Venetoclax) and obinutuzumab combination compared to the chlorambucil and obinutuzumab chemotherapy regimen.
Lead Product(s): Venetoclax,Obinutuzumab
Therapeutic Area: Oncology Brand Name: Venclexta
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 06, 2022
Lead Product(s) : Venetoclax,Obinutuzumab
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
New Data Demonstrates AbbVie's VENCLYXTO®/VENCLEXTA® Combination Sustained Progression-Free Surv...
Details : Data shows that after more than five years of median follow-up (65.4 months), PFS remained significantly superior among patients treated with the VENCLEXTA (Venetoclax) and obinutuzumab combination compared to the chlorambucil and obinutuzumab chemothera...
Product Name : Venclexta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 06, 2022
Details:
VENCLEXTA®/VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis.
Lead Product(s): Venetoclax,Azacitidine
Therapeutic Area: Oncology Brand Name: Venclexta
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: F. Hoffmann-La Roche
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 21, 2021
Lead Product(s) : Venetoclax,Azacitidine
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : F. Hoffmann-La Roche
Deal Size : Inapplicable
Deal Type : Inapplicable
Venetoclax (VENCLEXTA®) Granted US FDA Breakthrough Therapy Designation (BTD) in Higher Risk Myel...
Details : VENCLEXTA®/VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction proces...
Product Name : Venclexta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 21, 2021
Details:
In addition, assessment in peripheral blood 30 months after the end of treatment showed that 26.9% of patients treated with VENCLEXTA (venetoclax) still had undetectable MRD (<10-4) compared with 3.2% of patients in the study arm who received obinutuzumab plus chlorambucil.
Lead Product(s): Venetoclax,Obinutuzumab
Therapeutic Area: Oncology Brand Name: Venclexta
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: F. Hoffmann-La Roche
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 07, 2021
Lead Product(s) : Venetoclax,Obinutuzumab
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : F. Hoffmann-La Roche
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : In addition, assessment in peripheral blood 30 months after the end of treatment showed that 26.9% of patients treated with VENCLEXTA (venetoclax) still had undetectable MRD (<10-4) compared with 3.2% of patients in the study arm who received obinutuzuma...
Product Name : Venclexta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 07, 2021
Details:
Ibrutinib plus venetoclax is an investigational fixed-duration combination. Patients received 3 cycles of ibrutinib lead-in followed by 12 cycles of ibrutinib + venetoclax (Ibr 420 mg/day PO; Ven ramp up to 400 mg/day PO).
Lead Product(s): Venetoclax,Ibrutinib
Therapeutic Area: Oncology Brand Name: Venclexta
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 06, 2021
Lead Product(s) : Venetoclax,Ibrutinib
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ibrutinib plus venetoclax is an investigational fixed-duration combination. Patients received 3 cycles of ibrutinib lead-in followed by 12 cycles of ibrutinib + venetoclax (Ibr 420 mg/day PO; Ven ramp up to 400 mg/day PO).
Product Name : Venclexta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 06, 2021
Details:
Latest data from the CAPTIVATE study underscore that IMBRUVICA in an all-oral fixed-duration combination with venetoclax also delivers a high rate of progression-free survival at two years while enabling treatment-free remission for patients.
Lead Product(s): Ibrutinib,Venetoclax
Therapeutic Area: Oncology Brand Name: Imbruvica
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Johnson & Johnson Innovative Medicine
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 19, 2021
Lead Product(s) : Ibrutinib,Venetoclax
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Johnson & Johnson Innovative Medicine
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Latest data from the CAPTIVATE study underscore that IMBRUVICA in an all-oral fixed-duration combination with venetoclax also delivers a high rate of progression-free survival at two years while enabling treatment-free remission for patients.
Product Name : Imbruvica
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 19, 2021
Details:
Positive opinion based on data from the VIALE-A and M14-358 trials, which evaluated the safety, efficacy and pharmacokinetics of VENCLYXTO in combination with hypomethylating agents in adult patients with AML.
Lead Product(s): Venetoclax,Azacitidine
Therapeutic Area: Oncology Brand Name: Venclyxto
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 23, 2021
Lead Product(s) : Venetoclax,Azacitidine
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Positive opinion based on data from the VIALE-A and M14-358 trials, which evaluated the safety, efficacy and pharmacokinetics of VENCLYXTO in combination with hypomethylating agents in adult patients with AML.
Product Name : Venclyxto
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 23, 2021
Details:
In the VIALE-A trial, the median overall survival of patients who received VENCLEXTA plus azacitidine was 14.7 months (11.9, 18.7) vs 9.6 months (7.4, 12.7) in patients who received azacitidine in combination with placebo.
Lead Product(s): Venetoclax,Azacitidine
Therapeutic Area: Oncology Brand Name: Venclexta
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Genentech
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 15, 2020
Lead Product(s) : Venetoclax,Azacitidine
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Genentech
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : In the VIALE-A trial, the median overall survival of patients who received VENCLEXTA plus azacitidine was 14.7 months (11.9, 18.7) vs 9.6 months (7.4, 12.7) in patients who received azacitidine in combination with placebo.
Product Name : Venclexta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 15, 2020
Details:
The FDA approval of VENCLEXTA for newly-diagnosed AML patients who are ineligible for intensive chemotherapy is supported by data from a series of trials including two Phase 3 trials - VIALE-A (M15-656) and VIALE-C (M16-043).
Lead Product(s): Venetoclax,Cytarabine
Therapeutic Area: Oncology Brand Name: Venclexta
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 16, 2020
Lead Product(s) : Venetoclax,Cytarabine
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
AbbVie's VENCLEXTA® (venetoclax) Receives FDA Full Approval for Acute Myeloid Leukemia (AML)
Details : The FDA approval of VENCLEXTA for newly-diagnosed AML patients who are ineligible for intensive chemotherapy is supported by data from a series of trials including two Phase 3 trials - VIALE-A (M15-656) and VIALE-C (M16-043).
Product Name : Venclexta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 16, 2020
Regulatory Info : RX
Registration Country : USA
Brand Name : VENCLEXTA
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2016-04-11
Application Number : 208573
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Norway
Brand Name : Venclyxto
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 100 mg
Packaging : Blister, endose
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Venclyxto
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 50 mg
Packaging : Blister, endose
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Venclyxto
Dosage Form : Filmtabl
Dosage Strength : 100mg
Packaging :
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Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Venclyxto
Dosage Form : Filmtabl
Dosage Strength : 50mg
Packaging :
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Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : VENCLEXTA
Dosage Form : KIT
Dosage Strength : 50MG
Packaging : 4 BLISTER PACKS
Approval Date :
Application Number : 2458063
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Venclexta 50mg
Dosage Form : FCT
Dosage Strength : 50mg
Packaging : 7X1mg
Approval Date :
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Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Australia
Brand Name : Venclexta
Dosage Form :
Dosage Strength :
Packaging : 120
Approval Date :
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Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Venclexta
Dosage Form :
Dosage Strength :
Packaging : 120
Approval Date :
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Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Venclexta
Dosage Form :
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Packaging : 7
Approval Date :
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Registration Country : Australia
Regulatory Info :
Registration Country : Norway
Brand Name : Venclyxto
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 10 mg
Packaging : Blister, endose
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Venclyxto
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 100 mg
Packaging : Blister, endose
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Venclyxto
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 100 mg
Packaging : Blister, endose
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Venclyxto
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 100 mg
Packaging : Blister, endose
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Venclyxto
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 50 mg
Packaging : Blister, endose
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Venclyxto
Dosage Form : Filmtabl
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Venclyxto
Dosage Form : Filmtabl
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Venclyxto
Dosage Form : Filmtabl
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Venclyxto
Dosage Form : Filmtabl
Dosage Strength : 10mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Venclyxto
Dosage Form : Filmtabl
Dosage Strength : 50mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : VENCLEXTA
Dosage Form : TABLET
Dosage Strength : 10MG
Packaging : Feb-14
Approval Date :
Application Number : 2458039
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : VENCLEXTA
Dosage Form : TABLET
Dosage Strength : 50MG
Packaging : 01-Jul
Approval Date :
Application Number : 2458047
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : VENCLEXTA
Dosage Form : TABLET
Dosage Strength : 100MG
Packaging : 1/120
Approval Date :
Application Number : 2458055
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : VENCLEXTA
Dosage Form : KIT
Dosage Strength : 10MG
Packaging : 4 BLISTER PACKS
Approval Date :
Application Number : 2458063
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : VENCLEXTA
Dosage Form : KIT
Dosage Strength : 50MG
Packaging : 4 BLISTER PACKS
Approval Date :
Application Number : 2458063
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : VENCLEXTA
Dosage Form : KIT
Dosage Strength : 100MG
Packaging : 4 BLISTER PACKS
Approval Date :
Application Number : 2458063
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Australia
Brand Name : Venclexta
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Venclexta
Dosage Form :
Dosage Strength :
Packaging : 7
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Venclexta
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Venclexta
Dosage Form :
Dosage Strength :
Packaging : 120
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Venclexta
Dosage Form :
Dosage Strength :
Packaging : 120
Approval Date :
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Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Venclexta
Dosage Form :
Dosage Strength :
Packaging : 120
Approval Date :
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Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Venclexta
Dosage Form :
Dosage Strength :
Packaging : 2
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Venclexta
Dosage Form :
Dosage Strength :
Packaging : 120
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Venclexta
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Venclexta
Dosage Form :
Dosage Strength :
Packaging : 120
Approval Date :
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Regulatory Info :
Registration Country : Australia
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Patents & EXCLUSIVITIES
ABOUT THIS PAGE
62
PharmaCompass offers a list of Venetoclax API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Venetoclax manufacturer or Venetoclax supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Venetoclax manufacturer or Venetoclax supplier.
PharmaCompass also assists you with knowing the Venetoclax API Price utilized in the formulation of products. Venetoclax API Price is not always fixed or binding as the Venetoclax Price is obtained through a variety of data sources. The Venetoclax Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Venetoclax manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Venetoclax, including repackagers and relabelers. The FDA regulates Venetoclax manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Venetoclax API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Venetoclax manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Venetoclax supplier is an individual or a company that provides Venetoclax active pharmaceutical ingredient (API) or Venetoclax finished formulations upon request. The Venetoclax suppliers may include Venetoclax API manufacturers, exporters, distributors and traders.
click here to find a list of Venetoclax suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Venetoclax DMF (Drug Master File) is a document detailing the whole manufacturing process of Venetoclax active pharmaceutical ingredient (API) in detail. Different forms of Venetoclax DMFs exist exist since differing nations have different regulations, such as Venetoclax USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Venetoclax DMF submitted to regulatory agencies in the US is known as a USDMF. Venetoclax USDMF includes data on Venetoclax's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Venetoclax USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Venetoclax suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Venetoclax Drug Master File in Korea (Venetoclax KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Venetoclax. The MFDS reviews the Venetoclax KDMF as part of the drug registration process and uses the information provided in the Venetoclax KDMF to evaluate the safety and efficacy of the drug.
After submitting a Venetoclax KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Venetoclax API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Venetoclax suppliers with KDMF on PharmaCompass.
A Venetoclax written confirmation (Venetoclax WC) is an official document issued by a regulatory agency to a Venetoclax manufacturer, verifying that the manufacturing facility of a Venetoclax active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Venetoclax APIs or Venetoclax finished pharmaceutical products to another nation, regulatory agencies frequently require a Venetoclax WC (written confirmation) as part of the regulatory process.
click here to find a list of Venetoclax suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Venetoclax as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Venetoclax API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Venetoclax as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Venetoclax and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Venetoclax NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Venetoclax suppliers with NDC on PharmaCompass.
Venetoclax Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Venetoclax GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Venetoclax GMP manufacturer or Venetoclax GMP API supplier for your needs.
A Venetoclax CoA (Certificate of Analysis) is a formal document that attests to Venetoclax's compliance with Venetoclax specifications and serves as a tool for batch-level quality control.
Venetoclax CoA mostly includes findings from lab analyses of a specific batch. For each Venetoclax CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Venetoclax may be tested according to a variety of international standards, such as European Pharmacopoeia (Venetoclax EP), Venetoclax JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Venetoclax USP).