Atirmociclib

Phase 1Small molecule

Pfizer

Atirmociclib is one of 96 small molecule programs targeting Hepatic Impairment. It is currently in Phase 1.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Hepatic ImpairmentRecruiting

Advanced CancerActive, not recruiting

Metastatic Breast CancerRecruiting

Hepatic ImpairmentPhase 1

Recruiting

Advanced CancerPhase 1

Active, not recruiting

Metastatic Breast CancerPreclinical

Recruiting

Competition

Competitive Landscape

53 competitors in Advanced Cancer

#DrugCompanyPhaseTrials

Taxol

Teva

Phase 2

13 2

Keytruda

Merck & Co.

Phase 2

12 3

Opdivo

Bristol-Myers Squibb

Phase 2

8 4

T-Dxd

Daiichi Sankyo

Phase 3

1 5

Herceptin

Roche

Phase 2

4 6

Verzenio

Eli Lilly

Phase 2

4 7

Elunate

Takeda

Phase 2

1 8

Paraplatin

AAvyxa

Phase 2

5 9

Torisel

PPrism Pharmaceuticals

Phase 2

5 10

Alimta

SShawn Eagle

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 1Active, not recruiting

Advanced Cancer

NCT06239467

Phase 1Recruiting

Hepatic Impairment

NCT07677358

Q4 2027

Phase 2Recruiting

Advanced Breast Cancer

NCT07427394

Q1 2028

Phase 1Active, not recruiting

Metastatic Breast Cancer

NCT05508906

Q3 2030

PreclinicalRecruiting

Metastatic Breast Cancer

NCT03424005

Clinical

Trials by Indication[1]

Advanced Breast Cancer2 trials

A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-08165784 MONOTHERAPY AND COMBINATIONS IN PARTICIPANTS WITH PIK3CA-MUTATED ADVANCED OR METASTATIC SOLID TUMORS

Not yet recruiting· Pfizer logo

Pfizer·Phase 1·NCT07897721·268 enrolled

A Phase IIa, Open-label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Camizestrant in Combination With Atirmociclib in Participants With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1b)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT07427394·24 enrolled

Metastatic Breast Cancer2 trials

A Phase Ib/II, Open-label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic Breast Cancer (Morpheus-panBC)

Recruiting· Roche logo

Roche·Preclinical·NCT03424005·1,132 enrolled

A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination With the CDK4/6 Inhibitor Ribociclib, With the PI3K Inhibitor Alpelisib, With the mTOR Inhibitor Everolimus, or With CDK4 Inhibitor Atirmociclib in Adult Subjects With Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer

Active, not recruiting·OOlema Pharmaceuticals, Inc.·Phase 1·NCT05508906·190 enrolled

Early Breast Cancer1 trial

AN INTERVENTIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF ATIRMOCICLIB (PF-07220060) PLUS GIREDESTRANT COMPARED TO GIREDESTRANT MONOTHERAPY AS ADJUVANT TREATMENT IN ADULT PARTICIPANTS WITH ESTROGEN RECEPTOR (ER)-POSITIVE, HER2-NEGATIVE EARLY-STAGE BREAST CANCER WITH MEDIUM OR HIGH RISK OF RECURRENCE (FOURLIGHT-4)

Not yet recruiting· Pfizer logo

Pfizer·Phase 3·NCT07890597·3,800 enrolled

Hepatic Impairment1 trial

A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF ATIRMOCICLIB IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITH NORMAL HEPATIC FUNCTION

Recruiting· Pfizer logo

Pfizer·Phase 1·NCT07677358·28 enrolled

Advanced Cancer1 trial

PIKture-01: First-in-Human Study of the PI3KαH1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants With Advanced Solid Tumors and as Part of Combination Therapy in Participants With Advanced Breast Cancer

Active, not recruiting·OOnKure, Inc.·Phase 1·NCT06239467·200 enrolled

1 more indication

Unspecified1 trial

A PHASE 1, OPEN-LABEL, TWO-PERIOD, CROSS-OVER STUDY TO EVALUATE DOSE PROPORTIONALITY OF ATIRMOCICLIB (PF-07220060) PHARMACOKINETICS WHEN ADMINISTERED UNDER FED CONDITIONS TO HEALTHY PARTICIPANTS

Completed· Pfizer logo

Pfizer·Phase 1·NCT07215078·72 enrolled

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for Atirmociclib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Atirmociclib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Atirmociclib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 1[1]
Company: Pfizer

Atirmociclib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2027

Q1 2028

Q3 2030

Trials by Indication[1]

Advanced Breast Cancer2 trials

Metastatic Breast Cancer2 trials

Early Breast Cancer1 trial

Hepatic Impairment1 trial

Advanced Cancer1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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