Drugs / IZORLISIB
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03767335 | Nov 2018 → Feb 2024 | breast cancer | Menarini Group | Completed | No outcome recorded |
| Phase 1 | NCT01222546 | Aug 2010 → Nov 2012 | cancer | Chugai Pharma Europe Ltd. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04495621 | Jul 2020 → Jan 2024 | colorectal cancer | Menarini Group | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05810870 | May 2023 → Apr 2026 overdue | breast cancer | MedSIR | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2020-12-07 | Menarini Group | Results Menarini Announces Results from New Preclinical Studies on MEN1611 for the Treatment of Breast Cancer at the 2020 San Antonio Breast Cancer Symposium menarini.com ↗ |
| 2020-09-17 | Menarini Group | Results Menarini Ricerche Announces Dose Escalation Results Of The Clinical Trial Of Men1611 In Breast Cancer menarini.com ↗
The combination of MEN1611 + trastuzumab +/- fulvestrant has shown an acceptable tolerability profile with no dose-limiting toxicities during the escalation phase, and most treatment emergent adverse events were reversible and manageable with supportive care. |
| 2019-09-23 | Menarini Group | Results ESMO Annual Meeting 2019: Menarini Ricerche presents the preclinical characterization of MEN1611, a novel PI3K inhibitor in development for the treatm menarini.com ↗
These promising preclinical data, provide a strong rationale for MEN 1611 progression in clinical development in breast cancer patients. |
| 2018-04-13 | Menarini Group | Results Menarini Ricerche to present the most recent pre-clinical data about the PI3K inhibitor MEN1611 at the AACR Annual Meeting 2018. menarini.com ↗
The results of these preclinical studies will be described in two posters. |
All press releases naming this drug 8 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IZORLISIB | ChEMBL registry synonym — accepted as the source's own label CHEMBL1684984 ↗ |
| Known as | CH5132799 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01222546 ↗ |
| Known as | CH5132799-000 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1684984 ↗ |
| Known as | MEN1611 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05810870 ↗ |
| Known as | PA-799 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1684984 ↗ |
| Action | Inhibit | “MEN1611 is an investigational drug which blocks a protein called PI3K” NCT03767335 ↗ |
| Modality | Small molecule | — CHEMBL1684984 ↗ |
| Route | Oral | “administered orally” NCT01222546 ↗ |
| Target | PIK3CA | “PI3K alpha inhibitor MEN1611 selectively binds to and inhibits PIK3CA and its mutated forms in the PI3K/Akt (protein kinase B)/mammalian target of rapamycin (mTOR) pathway.” NCT05810870 ↗ |