Drugs / Atirmociclib
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT07677358 | Jul 2026 → Aug 2027 expected | liver disorder | Pfizer | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07215078 | Oct 2025 → Jun 2026 overdue | — | Pfizer | Recruiting | No outcome recorded |
| Phase 1 | NCT07160738 | Sep → Nov 2025 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT07130097 | Aug → Oct 2025 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT06897683 | Mar → May 2025 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT06267963 | Jan → Apr 2024 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05923411 | Jul 2023 → Jun 2024 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05508906 | Aug 2022 → Dec 2027 expected | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | Olema Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05216432 | Dec 2021 → Apr 2027 expected | Her2-receptor negative breast cancer, PIK3CA-related overgrowth spectrum | Relay Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT06206837 | Feb 2024 → Sep 2025 overdue | breast cancer | Pfizer | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05262400 | Mar 2022 → Feb 2027 expected | breast cancer | Pfizer | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03424005 | Mar 2018 → Sep 2030 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 25 trials · 2 met primary | ||||||
| Phase 2 | NCT07427394 | May 2026 → Dec 2027 expected | female breast carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 2 | NCT06465368 | Jul 2024 → Jul 2025 | breast cancer | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT06105632 | Jan 2024 → Jan 2026 overdue | breast cancer | Pfizer | Active not recruiting | Met primary |
| Phase 2 | NCT04606446 | Nov 2020 → Jul 2029 expected | breast cancer, castration-resistant prostate carcinoma, non-small cell lung carcinoma | Pfizer | Recruiting | Met primary |
| Phase 2 | NCT04557449 | Sep 2020 → Sep 2026 overdue | breast neoplasm, liposarcoma, lung adenocarcinoma, prostate cancer | Pfizer | Active not recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06760637 | Jan 2025 → Jan 2029 expected | breast cancer | Pfizer | Active not recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT06239467 Background | Feb 2024 → Dec 2026 expected | breast cancer | OnKure, Inc. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-08-06 | Relay Therapeutics, Inc. | Results Relay Therapeutics Reports Second Quarter 2026 Financial Results and Corporate Updates relaytx.com ↗
44% objective response rate (ORR) reported in heavily pre-treated CDK4/6-experienced patients (median 3L) at unoptimized doses and ORR was similar across kinase and non-kinase PIK3CA mutations |
| 2026-04-27 | Relay Therapeutics, Inc. | Results Relay Therapeutics Announces Clinical Data for Zovegalisib plus Atirmociclib Triplet Combination Supportive of Further Development in Frontline Metastatic Breast Cancer relaytx.com ↗ |
| 2026-03-17 | Pfizer | Results Pfizer Announces Positive Topline Phase 2 Results for Next-Generation CDK4 Inhibitor, Atirmociclib, in Second-Line Metastatic Breast Cancer pfizer.com ↗
The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) as assessed by the investigator [HR: 0.60 (95% CI: (0.440, 0.825)), p=0.0007]. |
| 2024-09-11 | Pfizer | Results Pfizer Highlights Diverse Oncology Portfolio and Combination Approaches at ESMO 2024 pfizer.com ↗
initial data from a dose-escalation study evaluating the innovative combination of atirmociclib, a potential first-in-class CDK4-selective inhibitor, with PF-07104091, a novel CDK2-selective inhibitor, showed a manageable safety profile and encouraging efficacy in patients with heavily pretreated HR+/HER2- breast cancer. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-08-06 | Relay Therapeutics, Inc. | Relay Therapeutics Reports Second Quarter 2026 Financial Results and Corporate Updates relaytx.com ↗ |
| 2026-04-27 | Relay Therapeutics, Inc. | Relay Therapeutics Announces Clinical Data for Zovegalisib plus Atirmociclib Triplet Combination Supportive of Further Development in Frontline Metastatic Breast Cancer relaytx.com ↗ |
| 2026-03-17 | Pfizer | Pfizer Announces Positive Topline Phase 2 Results for Next-Generation CDK4 Inhibitor, Atirmociclib, in Second-Line Metastatic Breast Cancer pfizer.com ↗ |
| 2024-09-11 | Pfizer | Pfizer Highlights Diverse Oncology Portfolio and Combination Approaches at ESMO 2024 pfizer.com ↗ |
| 2024-06-05 | Relay Therapeutics, Inc. | Relay Therapeutics Announces Clinical Trial Collaboration with Pfizer to Evaluate Atirmociclib in Combination with RLY-2608 relaytx.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Atirmociclib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03424005 ↗ |
| Known as | PF-07220060 | “atirmociclib (PF-07220060)” NCT07215078 ↗ |
| Action | Inhibit | “CDK4 inhibitor” NCT04557449 ↗ |
| Modality | Small molecule | — CHEMBL5187755 ↗ |
| Route | Oral | “Atirmociclib administered orally” NCT03424005 ↗ |
| Target | CDK4 | “CDK4 inhibitor” NCT04557449 ↗ |