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Synopsis

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Chemistry

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Also known as: 1217486-61-7, Byl-719, Byl719, Piqray, Nvp-byl719, Vijoice
Molecular Formula
C19H22F3N5O2S
Molecular Weight
441.5  g/mol
InChI Key
STUWGJZDJHPWGZ-LBPRGKRZSA-N
FDA UNII
08W5N2C97Q

Alpelisib
Alpelisib is an orally bioavailable phosphatidylinositol 3-kinase (PI3K) inhibitor with potential antineoplastic activity. Alpelisib specifically inhibits PI3K in the PI3K/AKT kinase (or protein kinase B) signaling pathway, thereby inhibiting the activation of the PI3K signaling pathway. This may result in inhibition of tumor cell growth and survival in susceptible tumor cell populations. Activation of the PI3K signaling pathway is frequently associated with tumorigenesis. Dysregulated PI3K signaling may contribute to tumor resistance to a variety of antineoplastic agents.
1 2D Structure

Alpelisib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-1-N-[4-methyl-5-[2-(1,1,1-trifluoro-2-methylpropan-2-yl)pyridin-4-yl]-1,3-thiazol-2-yl]pyrrolidine-1,2-dicarboxamide
2.1.2 InChI
InChI=1S/C19H22F3N5O2S/c1-10-14(11-6-7-24-13(9-11)18(2,3)19(20,21)22)30-16(25-10)26-17(29)27-8-4-5-12(27)15(23)28/h6-7,9,12H,4-5,8H2,1-3H3,(H2,23,28)(H,25,26,29)/t12-/m0/s1
2.1.3 InChI Key
STUWGJZDJHPWGZ-LBPRGKRZSA-N
2.1.4 Canonical SMILES
CC1=C(SC(=N1)NC(=O)N2CCCC2C(=O)N)C3=CC(=NC=C3)C(C)(C)C(F)(F)F
2.1.5 Isomeric SMILES
CC1=C(SC(=N1)NC(=O)N2CCC[C@H]2C(=O)N)C3=CC(=NC=C3)C(C)(C)C(F)(F)F
2.2 Other Identifiers
2.2.1 UNII
08W5N2C97Q
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Byl719

2. Nvp-byl719

3. Piqray

2.3.2 Depositor-Supplied Synonyms

1. 1217486-61-7

2. Byl-719

3. Byl719

4. Piqray

5. Nvp-byl719

6. Vijoice

7. Alpelisib (byl719)

8. (s)-n1-(4-methyl-5-(2-(1,1,1-trifluoro-2-methylpropan-2-yl)pyridin-4-yl)thiazol-2-yl)pyrrolidine-1,2-dicarboxamide

9. Byl 719

10. Chembl2396661

11. 08w5n2c97q

12. (2s)-n1-[4-methyl-5-[2-(2,2,2-trifluoro-1,1-dimethylethyl)-4-pyridinyl]-2-thiazolyl]-1,2-pyrrolidinedicarboxamide

13. (2s)-1-n-[4-methyl-5-[2-(1,1,1-trifluoro-2-methylpropan-2-yl)pyridin-4-yl]-1,3-thiazol-2-yl]pyrrolidine-1,2-dicarboxamide

14. (s)-pyrrolidine-1,2-dicarboxylic Acid 2-amide 1-(4-methyl-5-(2-(2,2,2-trifluoro-1,1-dimethylethyl)-pyridin-4-yl)thiazol-2-yl)amide

15. 1,2-pyrrolidinedicarboxamide, N1-(4-methyl-5-(2-(2,2,2-trifluoro-1,1-dimethylethyl)-4-pyridinyl)-2-thiazolyl)-, (2s)-

16. 1,2-pyrrolidinedicarboxamide, N1-[4-methyl-5-[2-(2,2,2-trifluoro-1,1-dimethylethyl)-4-pyridinyl]-2-thiazolyl]-, (2s)-

17. Alpelisib [inn]

18. (2s)-n~1~-{4-methyl-5-[2-(1,1,1-trifluoro-2-methylpropan-2-yl)pyridin-4-yl]-1,3-thiazol-2-yl}pyrrolidine-1,2-dicarboxamide

19. (s)-n1-(4-methyl-5-(2-(1,1,1-trifluoro-2-methylpropan-2-yl)pyridin-4-yl)thiazol-2-yl)pyrrolidine-1,2-dicarboxamide.

20. Unii-08w5n2c97q

21. 4jps

22. 1lt

23. Alpelisib [usan]

24. Piqray (tn)

25. Alpelisib [jan]

26. Alpelisib [mi]

27. Alpelisib [usan:inn]

28. Alpelisib [who-dd]

29. Alpelisib (jan/usan/inn)

30. Gtpl7955

31. Schembl1911869

32. Alpelisib [orange Book]

33. Chebi:93752

34. Dtxsid70153355

35. Ex-a405

36. Byl 719; Byl719

37. Bdbm50436459

38. Mfcd22417085

39. Nsc765974

40. Nsc800065

41. S2814

42. Zinc68198368

43. Akos022186315

44. Ccg-269139

45. Cs-0663

46. Db12015

47. Nsc-765974

48. Nsc-800065

49. Ncgc00346717-03

50. Ncgc00346717-06

51. (2s)-n1-[4-methyl-5-[2-(2,2,2-trifluoro-1,1-dimethylethyl)-4-pyridinyl]-2-thiazolyl]-1,2-pyrrolidine

52. 1217486-47-9

53. As-16349

54. Hy-15244

55. Sw220128-1

56. Cas:1217486-61-7;byl-719

57. D11011

58. A855666

59. J-004627

60. Q27074391

61. (2s)-n1-(4-methyl-5-(1-(1,1,1-trifluoro-2-methylpropan-2-yl)pyridin-4-yl)-1,3-thiazol-2-yl)pyrrolidine-1,2-dicarboxamide

62. (2s)-n1-[4-methyl-5-[2-(2,2,2-trifluoro-1,1-dimethylethyl)-4-pyridinyl]-2-thiazolyl]-1,2-pyrrolidinedicarboxamide;alpelisib

2.4 Create Date
2012-03-05
3 Chemical and Physical Properties
Molecular Weight 441.5 g/mol
Molecular Formula C19H22F3N5O2S
XLogP33.2
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count8
Rotatable Bond Count4
Exact Mass441.14463062 g/mol
Monoisotopic Mass441.14463062 g/mol
Topological Polar Surface Area129 Ų
Heavy Atom Count30
Formal Charge0
Complexity663
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Alpelisib is indicated in combination with fulvestrant to treat postmenopausal women, and men, with advanced or metastatic breast cancer. This cancer must be hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, and PIK3CA mutated. The cancer must be detected by an FDA-approved test following progression on or after an endocrine-based regimen.


FDA Label


Treatment of breast cancer


Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy (see section 5. 1).


Treatment of PIK3CA related overgrowth spectrum


Treatment of Fallopian tube carcinoma (excluding rhabdomyosarcoma and germ cell tumours), Treatment of ovarian carcinoma (excluding rhabdomyosarcoma and germ cell tumours), Treatment of peritoneal carcinoma (excluding blastomas and sarcomas)


5 Pharmacology and Biochemistry
5.1 Pharmacology

Alpelisib does not prolong the QTcF interval. Patients taking alpelisib experience a dose dependent benefit from treatment with a 51% advantage of a 200mg daily dose over a 100mg dose and a 22% advantage of 300mg once daily over 150mg twice daily. This suggests patients requiring a lower dose may benefit from twice daily dosing.


5.2 ATC Code

L01XE


L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agents

L01E - Protein kinase inhibitors

L01EM - Phosphatidylinositol-3-kinase (pi3k) inhibitors

L01EM03 - Alpelisib


5.3 Absorption, Distribution and Excretion

Absorption

Alpelisib reached a peak concentration in plasma of 1320912ng/mL after 2 hours. Alpelisib has an AUClast of 11,1003760h ng/mL and an AUCINF of 11,1003770h ng/mL. A large, high fat meal increases the AUC by 73% and Cmax by 84% while a small, low fat meal increases the AUC by 77% and Cmax by 145%.


Route of Elimination

36% of an oral dose is eliminated as unchanged drug in the feces and 32% as the primary metabolite BZG791 in the feces. 2% of an oral dose is eliminated in the urine as unchanged drug and 7.1% as the primary metabolite BZG791. In total 81% of an oral dose is eliminated in the feces and 14% is eliminated in the urine.


Volume of Distribution

The apparent volume of distribution at steady state is 114L.


Clearance

The mean apparent oral clearance was 39.0L/h. The predicted clearance is 9.2L/hr under fed conditions.


5.4 Metabolism/Metabolites

Alpelisib is metabolized by hydrolysis reactions to form the primary metabolite. It is also metabolized by CYP3A4. The full metabolism of Alpelisib has yet to be determined but a series of reactions have been proposed. The main metabolic reaction is the substitution of an amine group on alpelisib for a hydroxyl group to form a metabolite known as M4 or BZG791. Alpelisib can also be glucuronidated to form the M1 and M12 metabolites.


5.5 Biological Half-Life

The mean half life of alprelisib is 8 to 9 hours.


5.6 Mechanism of Action

Phosphatidylinositol-3-kinase- (PI3K) is responsible for cell proliferation in response to growth factor-tyrosine kinase pathway activation. In some cancers PI3K's p110 catalytic subunit is mutated making it hyperactive. Alpelisib inhibits (PI3K), with the highest specificity for PI3K.


API SUPPLIERS

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ALPELISIB

NDC Package Code : 0078-1364

Start Marketing Date : 2022-04-05

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Alpelisib

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...

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, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry with over 350 Products portfolio. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.
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Arevipharma

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Alpelisib

About the Company : Arevipharma GmbH is a modern manufacturer of active pharmaceutical ingredients and intermediates with more than 140 years of expertise. Our customers are generic and research-based...

Arevipharma GmbH is a modern manufacturer of active pharmaceutical ingredients and intermediates with more than 140 years of expertise. Our customers are generic and research-based pharmaceutical companies on five continents. Our business partners recognise us as a competent, reliable and efficient company that is distinguished by individual service and an innovative character. The company’s 140 year history is based on the knowledge, skills, commitment and loyalty of its employees. Arevipharma also feels committed to its owners and investors. Due to the consistent expansion of new technologies,
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Alpelisib

About the Company : Conscientia Industrial is a pharmaceutical company, mainly developing, manufacturing, marketing APIs (Active Pharmaceutical Ingredients), intermediates, fine chemicals in China. We...

Conscientia Industrial is a pharmaceutical company, mainly developing, manufacturing, marketing APIs (Active Pharmaceutical Ingredients), intermediates, fine chemicals in China. We started business in early 2010, producing and providing products for both human and veterinary health at home and abroad. Conscientia Industrial makes regular productions and also provides custom synthesis, contract manufacturing services. We have series of products, such as Hormones, Prostaglandins, Peptides, Anti-cancer, Anti-tumor, Anti-virus, Anti-diabetic APIs and their related intermediates, impurities, chemicals.
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Alpelisib

About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products...

Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs
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Alpelisib

About the Company : ScinoPharm Taiwan Ltd. is a leading process R&D and API manufacturing service provider to the global pharmaceutical industry. With cGMP production facilities, ScinoPharm offers a w...

ScinoPharm Taiwan Ltd. is a leading process R&D and API manufacturing service provider to the global pharmaceutical industry. With cGMP production facilities, ScinoPharm offers a wide portfolio of services ranging from custom synthesis for early phase pharmaceutical activities to brand companies as well as APIs for the generic industry.Combining cost-effective resources and productivity of Asia along with unmatched regulatory know-how, ScinoPharm is uniquely positioned to serve global pharmaceutical R&D and manufacturing needs at any level and for any company in this sector.
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Alpelisib

About the Company : Shenzhen Tianyuan Pharmaceutical Technology Co., Ltd. is a manufacturer specializing in targeted anticancer drug research and is devoted to researching, manufacturing and marketing...

Shenzhen Tianyuan Pharmaceutical Technology Co., Ltd. is a manufacturer specializing in targeted anticancer drug research and is devoted to researching, manufacturing and marketing medical raw materials. The company's main products are crizotinib, afatinib, Capmatinib, Aloitinib, Sorafenib, Ibrutinib, Lenvatinib and many other kinds of TINI API.and intermediates Tianyuan pharmaceutical company in Zhangjiang Eastern has built 500 square meters of pilot laboratories, equipped with two sets of 50L glass reactor, four sets of 100L double reactor, six sets of 50L rotary evaporator and matching heating and cooling equipment.
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Alpelisib

About the Company : Viyash, true to its name, literally represents honesty and leadership in every sense. We are an integrated pharmaceutical company with a strong portfolio of niche formulations, ...

Viyash, true to its name, literally represents honesty and leadership in every sense. We are an integrated pharmaceutical company with a strong portfolio of niche formulations, APIs and advanced intermediates Viyash and its subsidiaries operate 10 API / Intermediate facilities with a combined capacity ~2000 KL and diversified capabilities in every aspect - small / large volume, potent / non-potent, regulated / semi-regulated markets. In addition, we also operate one formulation manufacturing facility in New Jersey, USA with a capacity of ~ 1.2 Bn units.
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ALPELISIB

Brand Name : PIQRAY

Dosage Form : TABLET;ORAL

Dosage Strength : 150MG

Packaging :

Approval Date : 2019-05-24

Application Number : 212526

Regulatory Info : RX

Registration Country : USA

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ALPELISIB

Brand Name : VIJOICE

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date : 2022-04-05

Application Number : 215039

Regulatory Info : RX

Registration Country : USA

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ALPELISIB

Brand Name : VIJOICE

Dosage Form : GRANULES;ORAL

Dosage Strength : 50MG/PACKET

Packaging :

Approval Date : 2024-04-24

Application Number : 218466

Regulatory Info : RX

Registration Country : USA

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Alpelisibum

Brand Name : Piqray

Dosage Form : Film-Coated Tablets

Dosage Strength : 150mg

Packaging :

Approval Date :

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Regulatory Info :

Registration Country : Switzerland

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Alpelisibum

Brand Name : Piqray

Dosage Form : Filmtabl

Dosage Strength : 200mg+50mg

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Regulatory Info :

Registration Country : Switzerland

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Alpelisibum

Brand Name : Piqray

Dosage Form : Filmtabl

Dosage Strength : 200mg+50mg

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Registration Country : Switzerland

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ALPELISIB

Brand Name : PIQRAY

Dosage Form : TABLET

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number : 2497077

Regulatory Info :

Registration Country : Canada

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ALPELISIB

Brand Name : PIQRAY

Dosage Form : TABLET

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number : 2497085

Regulatory Info :

Registration Country : Canada

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Alpelisib

Brand Name : PIVIKTO 200

Dosage Form : FCT

Dosage Strength : 200mg

Packaging : 56 X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Alpelisib

Brand Name : PIVIKTO 50

Dosage Form : FCT

Dosage Strength : 50mg

Packaging : 56 X1mg

Approval Date :

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Regulatory Info : Originator

Registration Country : South Africa

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Alpelisibum

Brand Name : Piqray

Dosage Form : Film-Coated Tablets

Dosage Strength : 150mg

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Registration Country : Switzerland

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Alpelisibum

Brand Name : Piqray

Dosage Form : Film-Coated Tablets

Dosage Strength : 150mg

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Registration Country : Switzerland

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Alpelisibum

Brand Name : Piqray

Dosage Form : Filmtabl

Dosage Strength : 200mg

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Registration Country : Switzerland

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Alpelisibum

Brand Name : Piqray

Dosage Form : Filmtabl

Dosage Strength : 200mg+50mg

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Regulatory Info :

Registration Country : Switzerland

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Alpelisibum

Brand Name : Piqray

Dosage Form : Filmtabl

Dosage Strength : 200mg+50mg

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Regulatory Info :

Registration Country : Switzerland

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ALPELISIB

Brand Name : PIQRAY

Dosage Form : TABLET

Dosage Strength : 150MG

Packaging :

Approval Date :

Application Number : 2497069

Regulatory Info :

Registration Country : Canada

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ALPELISIB

Brand Name : PIQRAY

Dosage Form : TABLET

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number : 2497077

Regulatory Info :

Registration Country : Canada

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ALPELISIB

Brand Name : PIQRAY

Dosage Form : TABLET

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number : 2497085

Regulatory Info :

Registration Country : Canada

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ALPELISIB

Brand Name : PIQRAY

Dosage Form : TABLET

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number : 2497085

Regulatory Info :

Registration Country : Canada

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South Africa

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Novartis South Africa (Pty) Ltd

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Alpelisib

Brand Name : PIVIKTO 200

Dosage Form : FCT

Dosage Strength : 200mg

Packaging : 56 X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Novartis South Africa (Pty) Ltd

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Pharmex
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Alpelisib

Brand Name : PIVIKTO 50

Dosage Form : FCT

Dosage Strength : 50mg

Packaging : 56 X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Novartis South Africa (Pty) Ltd

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Pharmex
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Novartis South Africa (Pty) Ltd

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Alpelisib

Brand Name : PIVIKTO 150mg

Dosage Form : FCT

Dosage Strength : 150mg

Packaging : 56X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Novartis South Africa (Pty) Ltd

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Pharmex
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Alpelisib

Brand Name : PIVIKTO 200mg

Dosage Form : FCT

Dosage Strength : 200mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Pipeline Prospector Oct 2024: Lundbeck acquires Longboard for US$ 2.6 bn; molecular glue degrader tech witnesses dealmaking
In October, several pharma companies posted their third quarter (Q3) results. Drugmakers like Pfizer, BMS, Roche, Novartis, Sanofi, Merck and Incyte reported higher-than-expected Q3 earnings, beating analyst expectations. Despite these healthy results, pharma indices continued on their downward journey that had begun in September. The Nasdaq Biotechnology Index (NBI) dropped 2.6 percent from 4,771.85 to 4,650.07. The SPDR S&P Biotech ETF (XBI) fell 1.6 percent from 98.61 to 97.03, and the S&P Biotechnology Select Industry Index (SPSIBI) decreased 1.9 percent from 7,707.4 to 7,561.29.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel) Lundbeck buys Longboard, AbbVie picks up Aliada, Merck acquires Modifi in US$ 1 bn+ deals In mergers and acquisitions, Denmark’s Lundbeck agreed to buy California-based Longboard Pharmaceuticals for US$ 2.6 billion. The acquisition centers around bexicaserin, a promising phase 3 candidate for rare epilepsies including Dravet syndrome and Lennox-Gastaut syndrome, with Lundbeck projecting potential peak sales of US$ 1.5 billion to US$ 2 billion for this asset.  AbbVie acquired Boston-based Aliada Therapeutics for US$ 1.4 billion after reportedly outbidding at least three other drugmakers. The acquisition brings innovative blood-brain barrier technology to AbbVie’s portfolio, along with ALIA-1758, a phase 1 compound showing potential as a best-in-class therapy for Alzheimer’s disease. AbbVie also partnered with EvolveImmune Therapeutics in a potential US$ 1.4 billion deal (plus US$ 65 million upfront) to develop next-generation cancer biotherapeutics. The collaboration will leverage EvolveImmune’s innovative T-cell engager platform to create multispecific biologics targeting various oncology indications. Merck bolstered its oncology pipeline through the acquisition of Modifi Biosciences in a deal valued up to US$ 1.3 billion. The acquisition targets novel DNA modification therapeutics for challenging brain tumors, particularly glioblastomas. Merck  also entered into a potential US$ 1.9 billion deal with Mestag Therapeutics to explore fibroblast therapies for inflammatory diseases, leveraging Mestag’s innovative platform.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel) Pfizer, Novartis, Biogen sign molecular glue degrader deals; Astra in US$ 2 bn pact with CSPC There were at least three deals signed in October in the molecular glue degrader technology space. These degraders represent a novel therapeutic approach by facilitating the degradation of disease-causing proteins that are otherwise difficult to target with conventional drugs. First, Pfizer partnered Triana Biomedicines in a deal potentially exceeding US$ 1.5 billion, focusing on cancer applications. Second, Novartis committed US$ 150 million upfront to Monte Rosa Therapeutics in a deal worth up to US$ 2.25 billion. And Biogen tied up with Neomorph, pledging up to US$ 1.45 billion for neurological and immunological applications. Among other deals, AstraZeneca entered into a US$ 2 billion licensing agreement with CSPC Pharmaceutical Group for a novel lipid-lowering therapy, while Recordati acquired global rights to Sanofi’s Enjaymo for US$ 825 million upfront, with additional milestone payments of up to US$ 250 million. The Recordati-Sanofi deal focuses on cold agglutinin disease (CAD), a rare autoimmune disorder, and includes rights to sutimlimab, the first and only targeted therapy for CAD patients. Roche demonstrated its commitment to gene therapy advancement by expanding its collaboration with Dyno Therapeutics, committing over US$ 1 billion for adeno-associated virus (AAV) vector development, with an upfront payment of US$ 50 million. This expanded partnership builds on their initial 2020 collaboration and aims to accelerate the development of innovative gene therapies for neurological diseases.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel) AbbVie wins FDA nod for subcutaneous Parkinson’s drug; Roche med okayed for breast cancer October marked significant advances in the treatment of several major diseases. FDA approved AbbVie’s Vyalev for advanced Parkinson’s disease. This innovative therapy, utilizing foscarbidopa and foslevodopa prodrugs, delivers round-the-clock symptom control through subcutaneous infusion. The treatment represents a major advancement in managing motor fluctuations in late-stage patients, with market analysts projecting peak sales exceeding US$ 2 billion. In the oncology space, a historic milestone was reached with FDA’s approval of Vyloy, the world’s first therapy targeting CLDN18.2 proteins in gastric cancer. Developed by Astellas, the drug was approved for use in combination with chemotherapy for treating advanced gastric or gastroesophageal junction adenocarcinoma in adults with HER2-negative, CLDN18.2-positive tumors. This approval validates Astellas’ strategic US$ 1.4 billion acquisition of Ganymed Pharmaceuticals in 2016. Roche strengthened its position in breast cancer treatment with the approval of Itovebi, an oral PI3K inhibitor for first-line treatment of advanced hormone receptor-positive, HER2-negative breast cancer with PIK3CA mutation. This approval positions Itovebi as a strong competitor to existing treatments like Novartis' Piqray and AstraZeneca's Truqap, with Roche projecting annual peak sales of US$ 2.3 billion. Novartis expanded the reach of its leukemia treatment Scemblix through an accelerated approval for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. This expansion significantly increases the eligible patient population by approximately four times, building on its existing approval as a third-line treatment. Pfizer expanded its presence in the respiratory syncytial virus (RSV) market as FDA broadened the approval of Abrysvo to include at risk adults aged 18 to 50 years, making it the first and only RSV vaccine authorized for this population. In hematology, Pfizer secured approval for Hympavzi marking its second hemophilia approval in six months. This approval follows the earlier authorization of Pfizer’s one-time gene therapy Beqvez for hemophilia B in April. Iterum Therapeutics received FDA approval for its new oral antibiotic, Orlynvah, designed to treat uncomplicated urinary tract infections (uUTIs) in adult women who have limited or no alternative oral antibacterial treatment options. This marks the first US approval for an oral penem antibiotic.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel)  Gilead withdraws Trodelvy, J&J discontinues late-stage study of its bladder cancer candidate In a notable development for bladder cancer treatment, Gilead Sciences announced the withdrawal of Trodelvy from the US market after the targeted therapy, which received accelerated FDA approval in 2021 for metastatic urothelial cancer, failed to demonstrate survival benefits in a crucial confirmatory study.  Johnson & Johnson decided to discontinue the late-stage study of TAR-200, their investigational bladder cancer therapy, after interim analysis showed no superior benefits compared to standard chemo-radiation therapy. In neurology, Marinus Pharmaceuticals faced disappointment when their phase 3 trial of oral ganaxolone (Ztalmy) failed to meet its primary endpoint in reducing seizures associated with tuberous sclerosis complex (a genetic disorder). Marinus’ stock fell nearly 100 percent in October.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel)  Our view The last quarter was a good one for several drugmakers. Pfizer saw a surge in sales of its Covid drug Paxlovid to US$ 2.7 billion, encouraging it to up its guidance for Covid-related sales from US$ 8.5 billion to US$ 10.5 billion. For BMS, blockbusters like blood thinner Eliquis and cancer treatment Revlimid continued to bring in revenue. Merck’s growth was driven by the world’s top-selling drug, Keytruda, which saw revenue jump 17 percent compared to Q3 2023, beating analysts’ estimates. In a nutshell, the robust Q3 earnings of major pharma companies signals strong industry fundamentals, the volatility in pharma indices notwithstanding.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel)

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https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-oct-2024-lundbeck-acquires-longboard-for-us-2-6-bn-molecular-glue-degrader-tech-witnesses-dealmaking

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07 Nov 2024

NEWS #PharmaBuzz

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US Medicaid Prescriptions

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Brand Name : Piqray

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Company : Novartis

Alpelisib

Drug Cost (USD) : 138,440,781

Year : 2023

Prescribers : 1673

Prescriptions : 6641

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Brand Name : Vijoice

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Brand Name : Vijoice

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Company : Novartis

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Drug Cost (USD) : 5,958,633

Year : 2023

Prescribers : 31

Prescriptions : 125

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Drug Cost (USD) : 122,245,171

Year : 2022

Prescribers : 1615

Prescriptions : 6275

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Drug Cost (USD) : 1,894,697

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Prescriptions : 29

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Drug Cost (USD) : 124,059,404

Year : 2021

Prescribers : 1779

Prescriptions : 6905

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Drug Cost (USD) : 145,606,866

Year : 2020

Prescribers : 2330

Prescriptions : 8735

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Drug Cost (USD) : 46,037,291

Year : 2019

Prescribers : 1171

Prescriptions : 2915

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US Patents

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US Patent Number : 8227462

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 212526

Patent Use Code : U-3809

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Patent Expiration Date : 2033-04-29

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US Patent Number : 8476268

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Application Number : 212526

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Patent Expiration Date : 2029-09-10

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US Patent Number : 8227462

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Application Number : 212526

Patent Use Code : U-3809

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Patent Expiration Date : 2033-04-29

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US Patent Number : 8476268

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Application Number : 215039

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Patent Expiration Date : 2029-09-10

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US Patent Number : 8476268

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Application Number : 218466

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Patent Expiration Date : 2029-09-10

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US Patent Number : 8227462

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Patent Expiration Date : 2029-09-10

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Exclusivity Code : I-937

Exclusivity Expiration Date : 2027-01-18

Application Number : 212526

Product Number : 1

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Exclusivity Code : ODE-396

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Exclusivity Code : ODE-396

Exclusivity Expiration Date : 2029-04-05

Application Number : 215039

Product Number : 3

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ABOUT THIS PAGE

Looking for 1217486-61-7 / Alpelisib API manufacturers, exporters & distributors?

Alpelisib manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Alpelisib 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 Alpelisib manufacturer or Alpelisib supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Alpelisib manufacturer or Alpelisib supplier.

PharmaCompass also assists you with knowing the Alpelisib API Price utilized in the formulation of products. Alpelisib API Price is not always fixed or binding as the Alpelisib Price is obtained through a variety of data sources. The Alpelisib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Alpelisib

Synonyms

1217486-61-7, Byl-719, Byl719, Piqray, Nvp-byl719, Vijoice

Cas Number

1217486-61-7

Unique Ingredient Identifier (UNII)

08W5N2C97Q

About Alpelisib

Alpelisib is an orally bioavailable phosphatidylinositol 3-kinase (PI3K) inhibitor with potential antineoplastic activity. Alpelisib specifically inhibits PI3K in the PI3K/AKT kinase (or protein kinase B) signaling pathway, thereby inhibiting the activation of the PI3K signaling pathway. This may result in inhibition of tumor cell growth and survival in susceptible tumor cell populations. Activation of the PI3K signaling pathway is frequently associated with tumorigenesis. Dysregulated PI3K signaling may contribute to tumor resistance to a variety of antineoplastic agents.

Alpelisib Manufacturers

A Alpelisib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alpelisib, including repackagers and relabelers. The FDA regulates Alpelisib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alpelisib 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 Alpelisib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Alpelisib Suppliers

A Alpelisib supplier is an individual or a company that provides Alpelisib active pharmaceutical ingredient (API) or Alpelisib finished formulations upon request. The Alpelisib suppliers may include Alpelisib API manufacturers, exporters, distributors and traders.

click here to find a list of Alpelisib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Alpelisib USDMF

A Alpelisib DMF (Drug Master File) is a document detailing the whole manufacturing process of Alpelisib active pharmaceutical ingredient (API) in detail. Different forms of Alpelisib DMFs exist exist since differing nations have different regulations, such as Alpelisib USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Alpelisib DMF submitted to regulatory agencies in the US is known as a USDMF. Alpelisib USDMF includes data on Alpelisib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alpelisib USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Alpelisib suppliers with USDMF on PharmaCompass.

Alpelisib NDC

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 Alpelisib as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Alpelisib API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Alpelisib 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Alpelisib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Alpelisib NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Alpelisib suppliers with NDC on PharmaCompass.

Alpelisib GMP

Alpelisib 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 Alpelisib 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 Alpelisib GMP manufacturer or Alpelisib GMP API supplier for your needs.

Alpelisib CoA

A Alpelisib CoA (Certificate of Analysis) is a formal document that attests to Alpelisib's compliance with Alpelisib specifications and serves as a tool for batch-level quality control.

Alpelisib CoA mostly includes findings from lab analyses of a specific batch. For each Alpelisib 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.

Alpelisib may be tested according to a variety of international standards, such as European Pharmacopoeia (Alpelisib EP), Alpelisib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alpelisib USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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