Palazestrant

Phase 3Small molecule

OOlema Pharmaceuticals, Inc.

Palazestrant is one of 68 small molecule programs targeting Breast Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Breast CancerActive, not recruiting

Advanced or Metastatic Solid TumorsRecruiting

Breast CancerPhase 3

Active, not recruiting

Advanced or Metastatic Solid TumorsPhase 1

Recruiting

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Palazestrant

OOlema Pharmaceuticals, Inc.

Phase 3

3 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 5

Tianeptine

Pfizer

Preclinical

1 6

Ablavar

LLantheus Medical Imaging

Preclinical

2 7

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

1 8

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

1 9

Naltrexone/bupropion

Novo Nordisk

Preclinical

1 10

Sertraline ODT

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

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

Timeline

Expected Milestones

Q3 2027

Phase 1Recruiting

Advanced or Metastatic Solid Tumors

NCT06784193

Q1 2028

Phase 1Active, not recruiting

Metastatic Breast Cancer

NCT05508906

Phase 3Active, not recruiting

Breast Cancer

NCT06016738

Q1 2032

Phase 3Recruiting

Breast Cancer

NCT07085767

Clinical

Trials by Indication[1]

Breast Cancer3 trials

A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients

Active, not recruiting·OOlema Pharmaceuticals, Inc.·Phase 1·NCT05266105·60 enrolled

A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)

Recruiting·OOlema Pharmaceuticals, Inc.·Phase 3·NCT07085767·1,000 enrolled

A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)

Active, not recruiting·OOlema Pharmaceuticals, Inc.·Phase 3·NCT06016738·510 enrolled

Advanced or Metastatic Solid Tumors1 trial

Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors

Recruiting·OOlema Pharmaceuticals, Inc.·Phase 1·NCT06784193·180 enrolled

Metastatic Breast Cancer1 trial

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

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Palazestrant. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Palazestrant compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Palazestrant. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Olema Pharmaceuticals, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: OOlema Pharmaceuticals, Inc.

Palazestrant

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q1 2028

Q1 2032

Trials by Indication[1]

Breast Cancer3 trials

Advanced or Metastatic Solid Tumors1 trial

Metastatic Breast Cancer1 trial

References

Drug Info

Quick Facts

Related News