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Chemistry

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Also known as: Gdc-0077, 2060571-02-8, Rg6114, Gdc0077, Ro7113755, Inavolisib [usan]
Molecular Formula
C18H19F2N5O4
Molecular Weight
407.4  g/mol
InChI Key
SGEUNORSOZVTOL-CABZTGNLSA-N
FDA UNII
L4C1UY2NYH

Inavolisib
Inavolisib is an orally available inhibitor of phosphatidylinositol 3-kinase (PI3K), with potential antineoplastic activity. inavolisib binds to and inhibits various members of the PI3K family, including activating mutations in the catalytic alpha isoform PIK3CA. PI3K inhibition prevents the activation of the PI3K-mediated signaling pathway and results in the inhibition of growth and survival of PI3K-overexpressing tumor cells. Dysregulation of the PI3K signaling pathway is frequently associated with tumorigenesis and tumor resistance to a variety of antineoplastic agents and radiotherapy. PIK3CA, which encodes the p110-alpha catalytic subunit of the class I PI3K, is frequently mutated in a variety of cancer cell types and plays a key role in cancer cell growth and invasion.
1 2D Structure

Inavolisib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-2-[[2-[(4S)-4-(difluoromethyl)-2-oxo-1,3-oxazolidin-3-yl]-5,6-dihydroimidazo[1,2-d][1,4]benzoxazepin-9-yl]amino]propanamide
2.1.2 InChI
InChI=1S/C18H19F2N5O4/c1-9(16(21)26)22-10-2-3-11-13(6-10)28-5-4-24-7-14(23-17(11)24)25-12(15(19)20)8-29-18(25)27/h2-3,6-7,9,12,15,22H,4-5,8H2,1H3,(H2,21,26)/t9-,12-/m0/s1
2.1.3 InChI Key
SGEUNORSOZVTOL-CABZTGNLSA-N
2.1.4 Canonical SMILES
CC(C(=O)N)NC1=CC2=C(C=C1)C3=NC(=CN3CCO2)N4C(COC4=O)C(F)F
2.1.5 Isomeric SMILES
C[C@@H](C(=O)N)NC1=CC2=C(C=C1)C3=NC(=CN3CCO2)N4[C@@H](COC4=O)C(F)F
2.2 Other Identifiers
2.2.1 UNII
L4C1UY2NYH
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (2s)-2-((2-((4s)-4-(difluoromethyl)-2-oxo-1,3-oxazolidin-3-yl)-5,6-dihydroimidazo(1,2-d)(1,4)benzoxazepin-9-yl)amino)propanamide

2. Gdc-0077

2.3.2 Depositor-Supplied Synonyms

1. Gdc-0077

2. 2060571-02-8

3. Rg6114

4. Gdc0077

5. Ro7113755

6. Inavolisib [usan]

7. L4c1uy2nyh

8. (2s)-2-[[2-[(4s)-4-(difluoromethyl)-2-oxo-1,3-oxazolidin-3-yl]-5,6-dihydroimidazo[1,2-d][1,4]benzoxazepin-9-yl]amino]propanamide

9. (s)-2-((2-((s)-4-(difluoromethyl)-2-oxooxazolidin-3-yl)-5,6-dihydrobenzo[f]imidazo[1,2-d][1,4]oxazepin-9-yl)amino)propanamide

10. Rg-6114

11. Ro-7113755

12. N~2~-{(4s,11ap)-2-[(4s)-4-(difluoromethyl)-2-oxo-1,3-oxazolidin-3-yl]-5,6-dihydroimidazo[1,2-d][1,4]benzoxazepin-9-yl}-l-alaninamide

13. Propanamide, 2-((2-((4s)-4-(difluoromethyl)-2-oxo-3-oxazolidinyl)-5,6-dihydroimidazo(1,2-d)(1,4)benzoxazepin-9-yl)amino)-, (2s)-

14. Mfcd31382124

15. Sgeunorsozvtol-cabztgnlsa-n

16. X3n

17. Inavolisib [inn]

18. Unii-l4c1uy2nyh

19. Inavolisib [who-dd]

20. Gtpl9636

21. Chembl4650215

22. Schembl18360780

23. Bdbm295665

24. Amy16810

25. Ex-a2685

26. Nsc800729

27. S8668

28. Us10112932, Compound 101

29. Who 11204

30. Akos040741785

31. At36699

32. Cs-6459

33. Db15275

34. Gdc-0077; Rg6114

35. Nsc-800729

36. Ac-31594

37. Ms-26989

38. Hy-101562

39. A903455

40. Gdc-0077;rg6114;ro-7113755

41. (2s)-2-((2-((4s)-4-(difluoromethyl)-2-oxo-3-oxazolidinyl)-5,6-dihydroimidazo(1,2-d)(1,4)benzoxazepin-9-yl)amino)propanamide

42. (2s)-2-({4-[(4s)-4-(difluoromethyl)-2-oxo-1,3-oxazolidin-3-yl]-9-oxa-3,6-diazatricyclo[8.4.0.0,tetradeca-1(14),2,4,10,12-pentaen-12-yl}amino)propanamide

43. (s)-2-((2-((s)-4-(difluoromethyl)- 2-oxooxazolidin-3-yl)-5,6- Dihydrobenzo[f]imidazo[1,2- D][1,4]oxazepin-9- Yl)amino)propanamide

44. (s)-2-((2-((s)-4-(difluoromethyl)-2-oxooxazolidin-3-yl)-5,6-dihydrobenzo[f]imidazo[1,2-d][1,4]oxazepin-9-yl)propanamide (gdc-0077)

2.4 Create Date
2017-02-18
3 Chemical and Physical Properties
Molecular Weight 407.4 g/mol
Molecular Formula C18H19F2N5O4
XLogP31.5
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count8
Rotatable Bond Count5
Exact Mass g/mol
Monoisotopic Mass g/mol
Topological Polar Surface Area112
Heavy Atom Count29
Formal Charge0
Complexity641
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Phosphoinositide-3 Kinase Inhibitors

Agents that inhibit PHOSPHOINOSITIDE-3 KINASE activity. (See all compounds classified as Phosphoinositide-3 Kinase Inhibitors.)


Drugs in Development

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Details:

Inavolisib is a small molecule drug, which is currently being evaluated in Phase II clinical studies for the treatment of breast neoplasms.


Lead Product(s): Inavolisib,Ribociclib,Fulvestrant

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 12, 2026

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01

F. Hoffmann-La Roche

Switzerland
arrow
PEGS Boston Summit
Not Confirmed

F. Hoffmann-La Roche

Switzerland
arrow
PEGS Boston Summit
Not Confirmed

Details : Inavolisib is a small molecule drug, which is currently being evaluated in Phase II clinical studies for the treatment of breast neoplasms.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 12, 2026

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Details:

Inavolisib is a small molecule drug, which is currently being evaluated in Phase II clinical studies for the treatment of breast neoplasms.


Lead Product(s): Inavolisib,Fulvestrant

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 27, 2026

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02

F. Hoffmann-La Roche

Switzerland
arrow
PEGS Boston Summit
Not Confirmed

F. Hoffmann-La Roche

Switzerland
arrow
PEGS Boston Summit
Not Confirmed

Details : Inavolisib is a small molecule drug, which is currently being evaluated in Phase II clinical studies for the treatment of breast neoplasms.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

January 27, 2026

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Details:

Itovebi (Inavolisib) is a Small Molecule drug, which is currently being evaluated in Phase II clinical studies for the treatment of Colorectal Neoplasms.


Lead Product(s): Inavolisib,Bevacizumab,Fluorouracil,Calcium Folinate,Oxaliplatin,Irinotecan Hydrochloride

Therapeutic Area: Oncology Brand Name: Itovebi

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 07, 2026

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03

F. Hoffmann-La Roche

Switzerland
arrow
PEGS Boston Summit
Not Confirmed

F. Hoffmann-La Roche

Switzerland
arrow
PEGS Boston Summit
Not Confirmed

Details : Itovebi (Inavolisib) is a Small Molecule drug, which is currently being evaluated in Phase II clinical studies for the treatment of Colorectal Neoplasms.

Product Name : Itovebi

Product Type : Miscellaneous

Upfront Cash : Inapplicable

January 07, 2026

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Details:

Inavolisib is a small molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Prostatic Neoplasms.


Lead Product(s): Inavolisib,Enzalutamide,FoundationOne® CDx (F1CDx) Assay

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 17, 2025

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04

F. Hoffmann-La Roche

Switzerland
arrow
PEGS Boston Summit
Not Confirmed

F. Hoffmann-La Roche

Switzerland
arrow
PEGS Boston Summit
Not Confirmed

Lead Product(s) : Inavolisib,Enzalutamide,FoundationOne® CDx (F1CDx) Assay

Therapeutic Area : Oncology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Inavolisib is a small molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Prostatic Neoplasms.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 17, 2025

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Details:

Inavolisib is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Liver Failure.


Lead Product(s): Inavolisib,Inapplicable

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 27, 2025

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05

Genentech

U.S.A
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PEGS Boston Summit
Not Confirmed

Genentech

U.S.A
arrow
PEGS Boston Summit
Not Confirmed

Details : Inavolisib is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Liver Failure.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 27, 2025

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Details:

Itovebi (inavolisib) is a kinase inhibitor indicated with palbociclib for treating endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer.


Lead Product(s): Inavolisib,Palbociclib

Therapeutic Area: Oncology Brand Name: Itovebi

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 23, 2025

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06

F. Hoffmann-La Roche

Switzerland
arrow
PEGS Boston Summit
Not Confirmed

F. Hoffmann-La Roche

Switzerland
arrow
PEGS Boston Summit
Not Confirmed

Details : Itovebi (inavolisib) is a kinase inhibitor indicated with palbociclib for treating endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer.

Product Name : Itovebi

Product Type : Miscellaneous

Upfront Cash : Inapplicable

July 23, 2025

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Details:

Inavolisib is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Breast Neoplasms.


Lead Product(s): Inavolisib,Ribociclib,Letrozole

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 08, 2025

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07

F. Hoffmann-La Roche

Switzerland
arrow
PEGS Boston Summit
Not Confirmed

F. Hoffmann-La Roche

Switzerland
arrow
PEGS Boston Summit
Not Confirmed

Details : Inavolisib is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Breast Neoplasms.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

July 08, 2025

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Details:

GDC-0077 (inavolisib) is a PI3K alpha Inhibitor in combination with palbociclib and fulvestran, which is currently being evaluated for the treatment of HR+/HER2-breast Cancer.


Lead Product(s): Inavolisib,Fulvestrant,Palbociclib

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 27, 2025

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08

Genentech

U.S.A
arrow
PEGS Boston Summit
Not Confirmed

Genentech

U.S.A
arrow
PEGS Boston Summit
Not Confirmed

Details : GDC-0077 (inavolisib) is a PI3K alpha Inhibitor in combination with palbociclib and fulvestran, which is currently being evaluated for the treatment of HR+/HER2-breast Cancer.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

January 27, 2025

blank

Details:

Inavolisib is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Breast Neoplasms.


Lead Product(s): Inavolisib,Palbociclib,Letrozole

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 24, 2025

blank

09

F. Hoffmann-La Roche

Switzerland
arrow
PEGS Boston Summit
Not Confirmed

F. Hoffmann-La Roche

Switzerland
arrow
PEGS Boston Summit
Not Confirmed

Details : Inavolisib is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Breast Neoplasms.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

January 24, 2025

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Details:

FoundationOne®Liquid CDx to be used as a companion diagnostic for Itovebi (inavolisib) for adults with endocrine-resistant, PIK3CA-mutated HR+/HER2-breast Cancer.


Lead Product(s): Inavolisib,Fulvestrant,Palbociclib

Therapeutic Area: Oncology Brand Name: Itovebi

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 11, 2024

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10

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : FoundationOne®Liquid CDx to be used as a companion diagnostic for Itovebi (inavolisib) for adults with endocrine-resistant, PIK3CA-mutated HR+/HER2-breast Cancer.

Product Name : Itovebi

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 11, 2024

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DATA COMPILATION #PharmaFlow

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FDA approvals drop 24% in H1 2025; GSK’s UTI med, Vertex’s non-opioid painkiller lead pack of first-in-class meds
It has been a turbulent year for the US Food and Drug Administration (FDA), marked by reductions in both staff and budget, shake-ups at the top and a reduction in inspections. This upheaval has clearly impacted the functioning of the agency, with reports of missed deadlines and reduced responsiveness. This disruption resulted in a slowdown in new drug approvals in the first half of 2025 (H1 2025), as opposed to the same period last year. Incidentally, drug approvals in H1 2024 were also down by 19 percent compared to H1 2023. FDA’s Center for Drug Evaluation and Research (CDER) approved 16 novel drugs in H1 2025, down from 21 in H1 2024, a decline of nearly 24 percent. Of these, nine were small molecules and seven were biologics. The period saw eight first-in-class therapies get CDER’s approval, as opposed to 17 in H1 2024. FDA’s Center for Biologics Evaluation and Research (CBER) approved seven biologics in H1 2025, compared to eight in the same period last year. In comparison, both Health Canada and the European Medicines Agency (EMA) reported a strong rebound in approvals and authorizations, respectively. Health Canada approved 20 drugs in H1 2025, as opposed to 10 in H1 2024. Similarly, EMA authorized 19 new therapies in H1 2025, compared to 15 in H1 2024. Notably, EMA’s pending decisions increased to 25 in H1 2025, from 14 in the same period last year, while conditional authorizations remained static at five. This underscores EMA’s active regulatory pipeline, suggesting that more drugs could be approved in Europe soon.   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available) Vertex’s non-opioid painkiller, GSK’s antibiotic for UTI, Merck’s RSV antibody bag FDA nods Oncology remained the single largest category in H1 2025 with seven new drugs being approved by the FDA, followed by four rare diseases and disorders and as many infections and infective diseases.  The eight drugs that were designated first-in-class in H1 2025 are: Journavx (Suzetrigine), Imaavy (nipocalimab), Emrelis (telisotuzumab vedotin), Blujepa (gepotidacin mesylate), Qfitlia (fitusiran), Avmapki Fakzynja Co-Pack (avutometinib potassium/defactinib hydrochloride), Tryptyr (acoltremon), and Andembry (garadacimab). In January, a new class of non-opioid pain therapy made a debut — FDA approved Vertex Pharmaceuticals’ Journavx (suzetrigine). This first-in-class oral analgesic could bring in US$ 2.9 billion in sales for Vertex by 2030. The half year also saw a new oral antibiotic — GSK’s Blujepa (gepotidacin) — for treating uncomplicated urinary tract infections (uUTIs) bag FDA approval. This is the first new antibiotic for uUTIs in nearly three decades. It treats infections caused by resistant pathogens such as E. coli and K. pneumoniae. In June, Merck’s Enflonsia (clesrovimab), a long-acting monoclonal antibody, won FDA approval to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants entering their first RSV season. A single 105 mg dose provides protection for about five months, the length of a typical RSV season. Enflonsia could bring in US$844 million in annual sales by 2030.   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)  FDA approves four meds for rare diseases, including SpringWorks’ Gomekli, Novartis’ Vanrafia In H1 2024, rare genetic diseases had witnessed some significant approvals. The trend continued in H1 2025. In February, Gomekli (mirdametinib), developed by SpringWorks Therapeutics, became the first approved therapy for neurofibromatosis type 1 (a genetic disorder that causes tumors to grow on nerve tissues) in adult and pediatric patients who have symptomatic plexiform neurofibromas (benign, complex nerve tumors) not amenable to complete resection. Analysts expect peak sales of around US$ 0.8 billion by 2030. Post this approval, SpringWorks got acquired by Merck KGaA for approximately US$ 3.9 billion. The same month, Ono Pharma-owned Deciphera’s Romvimza (vimseltinib) became the first oral therapy approved for another rare disease known as symptomatic tenosynovial giant cell tumor. This is a benign but aggressive growth that can be painful. This new drug offers patients an option beyond surgery. In March, Sanofi’s Qfitlia (fitusiran) was approved for routine prophylaxis in hemophilia A or B, with or without inhibitors. And in April, Novartis’ Vanrafia (atrasentan) was granted accelerated approval for IgA nephropathy (a chronic autoimmune kidney disease), which is at the risk of rapid progression. Vanrafia could bring in sales of over US$ 735 million by 2030. Johnson & Johnson secured approval for Imaavy (nipocalimab-aahu) for generalized myasthenia gravis (a chronic autoimmune disease that causes muscle weakness) in adults and adolescents. Imaavy’s sales could cross US$1.17 billion by 2030. Rare diseases continue to attract regulatory attention, with the trend carrying into the current quarter. July witnessed two noteworthy rare-disease approvals — Ekterly (garadacimab), CSL’s once-monthly prophylactic treatment for hereditary angioedema (a genetic disorder that causes recurrent episodes of swellings), and Sephience (pegvaliase-abcx), BioMarin’s new therapy for phenylketonuria (a rare metabolic disorder).   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)  FDA greenlights new oncology therapies, including Astra’s Datroway, AbbVie’s Emrelis The field of oncology saw some notable new drug approvals. In January, Datroway (datopotamab deruxtecan), an antibody-drug conjugate (ADC) developed by AstraZeneca and Daiichi Sankyo, was granted approval for adults with unresectable or metastatic, hormone receptor-positive, HER2-negative breast cancer. Later, in June, the FDA granted accelerated approval  to AstraZeneca;s Datroway for adults with locally advanced or metastatic, EGFR-mutated non-small cell lung cancer. The drug’s peak annual sales are projected at about US$ 4.2 billion by 2030. In May, Emrelis (telisotuzumab vedotin-tllv), AbbVie’s ADC was granted FDA’s accelerated approval. Emrelis treats locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) characterized by significantly increased levels of the c-Met protein in cancer cells. FDA also approved a companion diagnostic test — Roche's Ventana — in May to determine the c-Met protein biomarker status in order to identify patients eligible for Emrelis.  The same month, FDA also granted accelerated approval to Verastem’s Avmapki Fakzynja Co-pack, a dual oral therapy for adults with KRAS‑mutated recurrent low‑grade serous ovarian cancer (LGSOC). This novel regimen combines two inhibitors — avutometinib and defactinib — to disrupt critical signaling pathways that fuel tumor growth. In ophthalmology, Alcon re-entered the prescription pharmaceutical market with Tryptry (acoltremon), a first-in-class TRPM8 agonist for dry eye disease, which stimulates corneal nerves to increase tear production.   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)  Our view The changes in the FDA are clearly having a far-reaching impact on the global pharmaceutical industry. There have been reports of drugmakers losing confidence in the FDA, which has been a gold standard for drug regulation. Some American biotechs are shifting early trials outside of the US. With EMA and Health Canada authorizing/approving a larger number of drugs in H1 2025, we do see some changes underway that may eventually reshape drug development.  

Impressions: 7624

https://www.pharmacompass.com/radio-compass-blog/fda-approvals-drop-24-in-h1-2025-gsk-s-uti-med-vertex-s-non-opioid-painkiller-lead-pack-of-first-in-class-meds

#PharmaFlow by PHARMACOMPASS
28 Aug 2025

STOCK RECAP #PipelineProspector

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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)

Impressions: 4524

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

#PharmaFlow by PHARMACOMPASS
07 Nov 2024

NEWS #PharmaBuzz

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https://www.globenewswire.com/news-release/2025/07/23/3119972/0/en/European-Commission-approves-Roche-s-Itovebi-for-people-with-ER-positive-HER2-negative-advanced-breast-cancer-with-a-PIK3CA-mutation.html

GLOBENEWSWIRE
23 Jul 2025

https://www.businesswire.com/news/home/20250531316801/en/New-Data-Show-Genentechs-Itovebi-Significantly-Extended-Survival-in-a-Certain-Type-of-HR-positive-Advanced-Breast-Cancer

BUSINESSWIRE
31 May 2025

https://www.globenewswire.com/news-release/2025/05/23/3087480/0/en/CHMP-recommends-EU-approval-of-Roche-s-Itovebi-for-PIK3CA-mutated-ER-positive-HER2-negative-advanced-breast-cancer.html

GLOBENEWSWIRE
23 May 2025

https://www.fiercepharma.com/pharma/asco-roches-itovebi-cuts-risk-death-33-certain-breast-cancer-patients-further-backing

FIERCE PHARMA
22 May 2025

https://www.businesswire.com/news/home/20250127792428/en

BUSINESSWIRE
27 Jan 2025

https://www.globenewswire.com/news-release/2024/11/11/2978601/0/en/Onco360-Has-Been-Selected-as-a-National-Specialty-Pharmacy-Partner-for-Itovebi-inavolisib.html

GLOBENEWSWIRE
11 Nov 2024

Patents & EXCLUSIVITIES

Check the patents & exclusivity for this product

US Patents

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01

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INAVOLISIB

US Patent Number : 11028100

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 219249

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-04-26

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INAVOLISIB

US Patent Number : 10851091

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 219249

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2036-07-01

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INAVOLISIB

US Patent Number : 12410189

Drug Substance Claim :

Drug Product Claim :

Application Number : 219249

Patent Use Code : U-4024

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-06-14

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Not Confirmed

INAVOLISIB

US Patent Number : 8242104

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 219249

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-09-27

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Not Confirmed

INAVOLISIB

US Patent Number : 9650393

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 219249

Patent Use Code : U-4024

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2036-07-01

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06

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PEGS Boston Summit
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PEGS Boston Summit
Not Confirmed

INAVOLISIB

US Patent Number : 11028100

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 219249

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-04-26

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PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

INAVOLISIB

US Patent Number : 9650393

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 219249

Patent Use Code : U-4024

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2036-07-01

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INAVOLISIB

US Patent Number : 8343955

Drug Substance Claim :

Drug Product Claim :

Application Number : 219249

Patent Use Code : U-4024

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-09-27

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PEGS Boston Summit
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INAVOLISIB

US Patent Number : 8343955

Drug Substance Claim :

Drug Product Claim :

Application Number : 219249

Patent Use Code : U-4024

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-09-27

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INAVOLISIB

US Patent Number : 11760753

Drug Substance Claim :

Drug Product Claim :

Application Number : 219249

Patent Use Code : U-4024

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2036-07-01

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US Exclusivities

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INAVOLISIB

Exclusivity Code : NCE

Exclusivity Expiration Date : 2029-10-10

Application Number : 219249

Product Number : 1

Exclusivity Details :

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INAVOLISIB

Exclusivity Code : NCE

Exclusivity Expiration Date : 2029-10-10

Application Number : 219249

Product Number : 2

Exclusivity Details :

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Health Canada Patents

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01

INAVOLISIB

Brand Name : ITOVEBI

Patent Number : 2772691

Filing Date : 2010-09-27

Strength per Unit : 3 mg

Dosage Form : TABLET

Human Or VET : Human

Route of Administration : ORAL

Patent Expiration Date : 1930-09-27

Date Granted : 2017-10-03

Abbvie CB

02

INAVOLISIB

Brand Name : ITOVEBI

Patent Number : 2982708

Filing Date : 2016-07-01

Strength per Unit : 3 mg

Dosage Form : TABLET

Human Or VET : Human

Route of Administration : ORAL

Patent Expiration Date : 1936-07-01

Date Granted : 2023-10-03

Abbvie CB

03

INAVOLISIB

Brand Name : ITOVEBI

Patent Number : 2772691

Filing Date : 2010-09-27

Strength per Unit : 9 mg

Dosage Form : TABLET

Human Or VET : Human

Route of Administration : ORAL

Patent Expiration Date : 1930-09-27

Date Granted : 2017-10-03

Abbvie CB

04

INAVOLISIB

Brand Name : ITOVEBI

Patent Number : 2982708

Filing Date : 2016-07-01

Strength per Unit : 9 mg

Dosage Form : TABLET

Human Or VET : Human

Route of Administration : ORAL

Patent Expiration Date : 1936-07-01

Date Granted : 2023-10-03

Abbvie CB
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

ABOUT THIS PAGE

Looking for 2060571-02-8 / Inavolisib API manufacturers, exporters & distributors?

Inavolisib manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Inavolisib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Inavolisib manufacturer or Inavolisib supplier for your needs.

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

API | Excipient name

Inavolisib

Synonyms

Gdc-0077, 2060571-02-8, Rg6114, Gdc0077, Ro7113755, Inavolisib [usan]

Cas Number

2060571-02-8

Unique Ingredient Identifier (UNII)

L4C1UY2NYH

About Inavolisib

Inavolisib is an orally available inhibitor of phosphatidylinositol 3-kinase (PI3K), with potential antineoplastic activity. inavolisib binds to and inhibits various members of the PI3K family, including activating mutations in the catalytic alpha isoform PIK3CA. PI3K inhibition prevents the activation of the PI3K-mediated signaling pathway and results in the inhibition of growth and survival of PI3K-overexpressing tumor cells. Dysregulation of the PI3K signaling pathway is frequently associated with tumorigenesis and tumor resistance to a variety of antineoplastic agents and radiotherapy. PIK3CA, which encodes the p110-alpha catalytic subunit of the class I PI3K, is frequently mutated in a variety of cancer cell types and plays a key role in cancer cell growth and invasion.

INAVOLISIB [WHO-DD] Manufacturers

A INAVOLISIB [WHO-DD] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of INAVOLISIB [WHO-DD], including repackagers and relabelers. The FDA regulates INAVOLISIB [WHO-DD] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. INAVOLISIB [WHO-DD] API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

INAVOLISIB [WHO-DD] Suppliers

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

INAVOLISIB [WHO-DD] GMP

INAVOLISIB [WHO-DD] 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 INAVOLISIB [WHO-DD] GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right INAVOLISIB [WHO-DD] GMP manufacturer or INAVOLISIB [WHO-DD] GMP API supplier for your needs.

INAVOLISIB [WHO-DD] CoA

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

INAVOLISIB [WHO-DD] CoA mostly includes findings from lab analyses of a specific batch. For each INAVOLISIB [WHO-DD] 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.

INAVOLISIB [WHO-DD] may be tested according to a variety of international standards, such as European Pharmacopoeia (INAVOLISIB [WHO-DD] EP), INAVOLISIB [WHO-DD] JP (Japanese Pharmacopeia) and the US Pharmacopoeia (INAVOLISIB [WHO-DD] 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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