Inavolisib

also known as GDC-0077 · Itovebi · RG-6114 · RO-7113755

Small molecule targets PIK3CA via inhibition

Developed for: breast cancer · cancer · colorectal cancer · triple-negative breast carcinoma · cancer of unknown primary site · endometrial cancer · endometrial carcinoma · estrogen-receptor positive breast cancer
+5 more
· female breast carcinoma · HER2 positive breast carcinoma · ovarian cancer · pancreatic ductal adenocarcinoma · prostate carcinoma
Investigated by: Hoffmann-La Roche · Genentech, Inc. · Pfizer · Foundation Medicine · German Cancer Research Center · Alliance Foundation Trials, LLC.
+17 more
· Bryan Schneider, MD · Eli Lilly and Company · European Network of Gynaecological Oncological Trial Groups (ENGOT) · Fudan University · GBG Forschungs GmbH · GOG Foundation · Gilead Sciences · Hu Hai · Indiana University · MedSIR · National Cancer Institute, Naples · Novartis · Roche Pharma AG · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Vera Bradley Foundation for Breast Cancer · Zhejiang Cancer Hospital · Zhimin Shao

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Label expansion	US (FDA)	ITOVEBI	—	2026-04-15	fda.gov ↗
Approved	EU (EMA)	Itovebi	—	2025-07-18	europa.eu ↗
Approved	US (FDA)	ITOVEBI	—	2024-10-10	fda.gov ↗

Trials 31 · a red edge is where a trial was stopped

today

US approved 2024

EU approved 2025

NCT07694973 · Ph 2 NCT07618390 · Ph 2 NCT07522697 · Ph 2 NCT07405801 · Ph 2 NCT07441512 · Ph 2 NCT07287150 · Ph 2 NCT07368998 · Ph 2 NCT07323576 · Ph 2 NCT07245797 · Ph 2 NCT07054190 · Ph 2 NCT07144111 · Ph 1 NCT06790693 · Ph 3 NCT05708235 · Ph 2 NCT06496568 · Ph 1 NCT05894239 · Ph 3 NCT05332561 · Ph 2 NCT05646862 · Ph 3 NCT05862285 · Ph 3 NCT05306041 · Ph 2 NCT04929223 · Ph 1 NCT04486352 · Ph 1/2 NCT04551521 · Ph 2 NCT04931342 · Ph 2 NCT04849364 · Ph 2 NCT04802759 · Ph 1/2 NCT04589845 · Ph 2 NCT04632992 · Ph 2 NCT04449874 · Ph 1 NCT04191499 · Ph 2/3 NCT03424005 · Ph 1/2 NCT03006172 · Ph 1

20172018201920202021202220232024202520262027202820292030203120322033

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 15 trials
Phase 1	NCT07144111	Aug 2025 → Sep 2026 expected	—	Genentech, Inc.	Recruiting	No outcome recorded
Phase 1	NCT06496568	Dec 2023 → Jul 2027 expected	—	Hoffmann-La Roche	Active not recruiting	No outcome recorded
Phase 1	NCT04929223	Oct 2021 → Aug 2030 expected	colorectal cancer	Hoffmann-La Roche	Recruiting	No outcome recorded
Phase 1	NCT04449874	Jul 2020 → Dec 2027 expected	colorectal cancer, non-small cell lung carcinoma	Genentech, Inc.	Active not recruiting	No outcome recorded
Phase 1	NCT03006172	Dec 2016 → Dec 2026 expected	breast cancer	Genentech, Inc.	Active not recruiting	No outcome recorded
Phase 1/23 trials
Phase 1/2	NCT04486352	Oct 2021 → Oct 2026 expected	endometrial cancer	Alliance Foundation Trials, LLC.	Recruiting	No outcome recorded
Phase 1/2	NCT04802759	Jun 2021 → May 2029 expected	estrogen-receptor positive breast cancer	Hoffmann-La Roche	Recruiting	No outcome recorded
Phase 1/2	NCT03424005	Mar 2018 → Sep 2030 expected	breast cancer	Hoffmann-La Roche	Recruiting	No outcome recorded
Phase 218 trials
Phase 2	NCT07694973	Aug 2026 → Jun 2028 expected	pancreatic ductal adenocarcinoma	Fudan University	Not yet recruiting	No outcome recorded
Phase 2	NCT07618390	Jun 2026 → Dec 2028 expected	breast cancer	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Not yet recruiting	No outcome recorded
Phase 2	NCT07522697	May 2026 → May 2030 expected	endometrial carcinoma	National Cancer Institute, Naples	Not yet recruiting	No outcome recorded
Phase 2	NCT07405801	Apr 2026 → Dec 2028 expected	breast cancer	Hoffmann-La Roche	Recruiting	No outcome recorded
Phase 2	NCT07441512	Mar 2026 → Mar 2028 expected	triple-negative breast carcinoma	Hu Hai	Not yet recruiting	No outcome recorded
Phase 2	NCT07287150	Mar 2026 → Mar 2028 expected	prostate carcinoma	Hoffmann-La Roche	Recruiting	No outcome recorded
Phase 2	NCT07368998	Feb 2026 → Oct 2028 expected	breast cancer	Hoffmann-La Roche	Recruiting	No outcome recorded
Phase 2	NCT07323576	Feb 2026 → Mar 2029	colorectal cancer	Hoffmann-La Roche	Withdrawn	No outcome recorded
Phase 2	NCT07245797	Dec 2025 → Dec 2026 expected	breast cancer	Zhimin Shao	Not yet recruiting	No outcome recorded
Phase 2	NCT07054190	Sep 2025 → Jul 2027 expected	breast cancer	Hoffmann-La Roche	Recruiting	No outcome recorded
Phase 2	NCT05708235	Apr 2024 → Jun 2028 expected	breast cancer	MedSIR	Recruiting	No outcome recorded
Phase 2	NCT05332561	Jun 2023 → Mar 2030 expected	female breast carcinoma	German Cancer Research Center	Recruiting	No outcome recorded
Phase 2	NCT05306041	Jan 2023 → Oct 2026 expected	HER2 positive breast carcinoma	GBG Forschungs GmbH	Recruiting	No outcome recorded
Phase 2	NCT04551521	Oct 2021 → Dec 2024	cancer	German Cancer Research Center	Completed	No outcome recorded
Phase 2	NCT04931342	Oct 2021 → Feb 2028 expected	ovarian cancer	Hoffmann-La Roche	Active not recruiting	No outcome recorded
Phase 2	NCT04849364	Aug 2021 → Oct 2024	triple-negative breast carcinoma	Bryan Schneider, MD	Terminated	No outcome recorded
Phase 2	NCT04589845	Jan 2021 → Sep 2032 expected	cancer	Hoffmann-La Roche	Active not recruiting	No outcome recorded
Phase 2	NCT04632992	Jan 2021 → Dec 2023	cancer of unknown primary site	Genentech, Inc.	Completed	No outcome recorded

Phase 2/31 trial
Phase 2/3	NCT04191499	Jan 2020 → Sep 2023 overdue	breast cancer	Hoffmann-La Roche	Active not recruiting	No outcome recorded
Phase 34 trials
Phase 3	NCT06790693	Apr 2025 → May 2032 expected	breast cancer	Hoffmann-La Roche	Recruiting	No outcome recorded
Phase 3	NCT05894239	Sep 2023 → Dec 2026 expected	breast cancer	Hoffmann-La Roche	Recruiting	No outcome recorded
Phase 3	NCT05646862	Jun 2023 → Nov 2026 expected	breast cancer	Hoffmann-La Roche	Active not recruiting	No outcome recorded
Phase 3	NCT05862285	Jun 2023 → Mar 2033 expected	cancer	Hoffmann-La Roche	Recruiting	No outcome recorded

Press releases naming this drug 10 releases

Date	Issuer	Release
2025-07-23	Roche Global Development	European Commission approves Roche’s Itovebi for people with ER-positive, HER2-negative, advanced breast cancer with a PIK3CA mutation roche.com ↗
2025-05-31	Roche Global Development	New data show Roche’s Itovebi significantly extended survival in a certain type of HR-positive advanced breast cancer roche.com ↗
2025-05-23	Roche Global Development	CHMP recommends EU approval of Roche’s Itovebi for PIK3CA-mutated, ER-positive, HER2-negative, advanced breast cancer roche.com ↗
2025-01-28	Roche Global Development	Roche’s Itovebi demonstrated statistically significant and clinically meaningful overall survival benefit in a certain type of HR-positive advanced breast cancer roche.com ↗
2024-10-31	Roche Global Development	New England Journal of Medicine publishes landmark phase III results for Roche’s Itovebi, showing more than doubling of progression-free survival in certain type of HR-positive advanced breast cancer roche.com ↗
2024-10-11	Roche Global Development	FDA approves Roche’s Itovebi, a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation roche.com ↗
2024-05-29	Roche Global Development	FDA grants Priority Review to Roche’s inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation roche.com ↗
2024-05-21	Roche Global Development	FDA grants Breakthrough Therapy Designation to Roche’s inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation roche.com ↗
2023-12-08	Roche Global Development	Roche’s inavolisib combination reduces the risk of disease progression by 57% in people with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation roche.com ↗
2023-12-05	Roche Global Development	Roche announces positive Phase III results for inavolisib combination in people with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation roche.com ↗

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 33 sources stand behind the page.

Field	Value	Cited text
Known as	Inavolisib	ClinicalTrials.gov intervention name — accepted as the source's own label NCT04931342 ↗ 30 NCT04449874 ↗ NCT07323576 ↗ NCT07287150 ↗ NCT07441512 ↗ NCT07368998 ↗ NCT07245797 ↗ NCT05306041 ↗ NCT05332561 ↗ NCT06496568 ↗ NCT07522697 ↗ NCT04589845 ↗ NCT04486352 ↗ NCT05862285 ↗ NCT07144111 ↗ NCT07618390 ↗ NCT04551521 ↗ NCT07405801 ↗ NCT04632992 ↗ NCT06790693 ↗ NCT07694973 ↗ NCT07054190 ↗ NCT04849364 ↗ NCT05708235 ↗ NCT05894239 ↗ NCT03424005 ↗ NCT04802759 ↗ NCT03006172 ↗ NCT05646862 ↗ NCT04929223 ↗ NCT04191499 ↗
Known as	GDC-0077	ChEMBL registry synonym — accepted as the source's own label CHEMBL4650215 ↗
Known as	Itovebi	ChEMBL registry synonym — accepted as the source's own label CHEMBL4650215 ↗
Known as	RG-6114	ChEMBL registry synonym — accepted as the source's own label CHEMBL4650215 ↗
Known as	RO-7113755	ChEMBL registry synonym — accepted as the source's own label CHEMBL4650215 ↗
Action	Inhibit	“PI3-kinase p110-alpha subunit inhibitor” CHEMBL4650215 ↗ 1 “small-molecule inhibitor of p110α” PMID 39236276 ↗ Sep 2024
Modality	Small molecule	“a potent and selective small-molecule inhibitor of p110α” PMID 39236276 ↗ Sep 2024
Route	Oral	“inavolisib administered orally” NCT03006172 ↗
Target	PIK3CA	“PI3-kinase p110-alpha subunit inhibitor” CHEMBL4650215 ↗