Asset profile

Inavolisib

Small molecule

Approvedregulatory verdict

Evidence outlook

Approved — HR+/HER2- Metastatic Breast Cancer

Regulatory approval supersedes design-level evidence grading — the trials behind approval are preserved below as the drug's evidence history.

How the evidence outlook works ↗

Upcoming events

(15 total)

Estimated primary-completion dates from ClinicalTrials.gov — registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (4)
October 2026 (1)
Phase 2HER2-positive Breast CancerRecruiting
Est. primary completion 2026-10 · NCT05306041 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

November 2026 (1)
Phase 3HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2026-11-13 · NCT05646862 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

December 2026 (2)
Phase 2HR+/HER2- Metastatic Breast CancerNot yet recruiting
Est. primary completion 2026-12-15 · NCT07245797 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2026-12-31 · NCT05894239 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2027 (1)
July 2027 (1)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-07-31 · NCT07054190 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2028 (5)
March 2028 (1)
Phase 2TNBC - Triple-Negative Breast Cancer, TNBCNot yet recruiting
Est. primary completion 2028-03-15 · NCT07441512 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

June 2028 (1)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-06-30 · NCT05708235 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

October 2028 (1)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-10-31 · NCT07368998 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

December 2028 (2)
Phase 2HR+/HER2- Metastatic Breast CancerNot yet recruiting
Est. primary completion 2028-12 · NCT07618390 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-12-19 · NCT07405801 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2029 (2)
May 2029 (1)
Phase 1/2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2029-05-30 · NCT04802759 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

June 2029 (1)
Phase 2HR+/HER2- Metastatic Breast CancerNot yet recruiting
Est. primary completion 2029-06-15 · NCT07748208 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2030 (2)
March 2030 (1)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2030-03 · NCT05332561 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

September 2030 (1)
Phase 1/2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2030-09-30 · NCT03424005 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2032 (1)
May 2032 (1)
Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2032-05-30 · NCT06790693 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

See the full readout calendar ↗

All registered studies

Research

Unlock the complete ClinicalTrials.gov registry

Research includes every linked study, indication filters, phase grouping and featured-trial cross-links.

Competitive landscape

Research

Unlock the competitor landscape

Research compares assets by shared mechanism and indication, including each competitor's stage in the relevant market.