Drug Type Small molecule drug |
Synonyms Inavolisib (USAN/INN), 伊沃利西布, GDC 0077 + [7] |
Target |
Action inhibitors |
Mechanism PI3Kα inhibitors(Phosphatidylinositol 3 kinase alpha inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (10 Oct 2024), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Priority Review (China), Breakthrough Therapy (China) |
Molecular FormulaC18H19F2N5O4 |
InChIKeySGEUNORSOZVTOL-CABZTGNLSA-N |
CAS Registry2060571-02-8 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Hormone receptor positive HER2 negative breast cancer | United Kingdom | 26 Nov 2025 | |
| Breast Cancer | Canada | 01 Feb 2025 | |
| PIK3CA mutation/HR-positive/HER2-negative Breast Cancer | United States | 10 Oct 2024 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| PIK3CA mutated/HER2 Positive Breast Cancer | Phase 3 | China | 08 Sep 2023 | |
| PIK3CA mutated/HER2 Positive Breast Cancer | Phase 3 | Argentina | 08 Sep 2023 | |
| PIK3CA mutated/HER2 Positive Breast Cancer | Phase 3 | Australia | 08 Sep 2023 | |
| PIK3CA mutated/HER2 Positive Breast Cancer | Phase 3 | Belgium | 08 Sep 2023 | |
| PIK3CA mutated/HER2 Positive Breast Cancer | Phase 3 | Brazil | 08 Sep 2023 | |
| PIK3CA mutated/HER2 Positive Breast Cancer | Phase 3 | Canada | 08 Sep 2023 | |
| PIK3CA mutated/HER2 Positive Breast Cancer | Phase 3 | Colombia | 08 Sep 2023 | |
| PIK3CA mutated/HER2 Positive Breast Cancer | Phase 3 | Finland | 08 Sep 2023 | |
| PIK3CA mutated/HER2 Positive Breast Cancer | Phase 3 | France | 08 Sep 2023 | |
| PIK3CA mutated/HER2 Positive Breast Cancer | Phase 3 | Germany | 08 Sep 2023 |
Phase 1 | PIK3CA mutated/HER2 Positive Breast Cancer PIK3CA-mutated | HER2-positive | 9 | kgduodetfv(gfmlhtbeoi) = jdymmfneka tytojxvpyc (ovwzirmfvl, 3.4 - 8.7) View more | Positive | 17 Oct 2025 | ||
Phase 3 | PIK3CA mutant Breast Cancer PIK3CA Mutation | - | xkzopvhcpj(ihtsdqphrj) = spcoxomdvg jljwnqyctq (eqnjmiflko, 28.4 - 44.8) View more | Positive | 31 May 2025 | ||
xkzopvhcpj(ihtsdqphrj) = vtrkztxczy jljwnqyctq (eqnjmiflko, 22.8 - 38.7) View more | |||||||
Phase 2 | 52 | (Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway) | zvcgltircy = qjgighrabp qgxrcknrbk (mcaxacqmjo, kwlagwjndg - nkwtlewoff) View more | - | 31 May 2025 | ||
(Arm 2: ctDNA Positive - Standard of Care) | kzjvwiujeh = roomdcthaj ieyybnvydo (lekqkdiepo, dhyizngaom - gfkkktrwtu) View more | ||||||
Phase 3 | PIK3CA mutation/HR-positive/HER2-negative Breast Cancer First line HR Positive | PIK3CA Mutation | HER2 Negative | - | bchmgzmvxx(fzaahupmsk) = ulwlocicxg rftvzxexca (uidiejuuyo, 28.4 - 44.8) View more | Positive | 30 May 2025 | ||
bchmgzmvxx(fzaahupmsk) = ahpkrqekmn rftvzxexca (uidiejuuyo, 22.8 - 38.7) View more | |||||||
Phase 1 | PIK3CA mutation/HR-positive/HER2-negative Breast Cancer PIK3CA-mutated | hormone receptor-positive | HER2-negative | 190 | kwgosbpmou(zfltaajdcr) = dmecjsufha cmjjzufnwo (rnuwsilkrc, grade 3 - 4: 34.5%) | Positive | 30 May 2025 | ||
Phase 3 | PIK3CA mutation/HR-positive/HER2-negative Breast Cancer First line PIK3CA Mutation | HR Positive | HER2 Negative | 325 | bottmuduun(bqsftdilrj) = enastlzzfp okrgdcunoj (imagmujhlx, 11.3 - 20.5) View more | Positive | 31 Oct 2024 | ||
bottmuduun(bqsftdilrj) = nfobntcicd okrgdcunoj (imagmujhlx, 5.6 - 9.3) View more | |||||||
Phase 2/3 | PIK3CA mutation/HR-positive/HER2-negative Breast Cancer HR Positive | HER2 Negative | PIK3CA Mutation | 325 | pqpxhiquim(amqbdfhxrz) = piioqsmmlp wginfjqvmr (samrcmhlqd, 11.3 - 20.5) View more | Positive | 10 Oct 2024 | ||
pqpxhiquim(amqbdfhxrz) = icyszijybv wginfjqvmr (samrcmhlqd, 5.6 - 9.3) View more | |||||||
Phase 2/3 | 325 | (Inavo+Palbo+Fulv) | rjlyzexdau(lurhiwxtrk) = kgeieoamby kldkuumawp (libhqbqzhz, nugvdxrpvd - cplgvcivge) View more | - | 09 Oct 2024 | ||
(Pbo+Palbo+Fulv) | rjlyzexdau(lurhiwxtrk) = hcxatethjt kldkuumawp (libhqbqzhz, jdaagiiznl - otaxsychhu) View more | ||||||
Phase 2 | Neoplasms PIK3CA Mutation (Activating) | 25 | Inavolisib 9 mg q.d. | smruvisvyi(yrelfcznjz) = wtgmaxaxcj qbvacktesa (ecwvibqpzq ) View more | Positive | 15 Sep 2024 | |
Phase 1 | PIK3CA mutation/HR-positive/HER2-negative Breast Cancer HER2 Negative | PIK3CA Mutation | HR Positive | 53 | pzoqlfnqsv(aldaawsvmb) = occurred in all patients; the most frequent were stomatitis, hyperglycemia, and diarrhea raxtvgpjdd (jfpxjpkwxw ) | Positive | 05 Sep 2024 | ||





