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Gedatolisib

Alternative Names: gedatolisib, pki-587, pf-05212384
Latest Update: 2024-11-21
Latest Update Note: Clinical Trial Update

Product Description

Mechanisms of Action: PI3K Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Intravenous

FDA Designation: Fast Track - Breast Cancer|Oncology Solid Tumor Unspecified *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Pfizer
Company Location: NEW YORK NY 10017
Company CEO: Albert Bourla
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Gedatolisib

Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Korea, Mexico, Poland, Romania, Singapore, Spain, Taiwan, United Kingdom, United States

Active Clinical Trial Count: 8

Highest Development Phases

Phase 3: Breast Cancer

Phase 2: Prostate Cancer|Prostatic Diseases|Triple Negative Breast Cancer|Urogenital Cancer

Phase 1: Head and Neck Cancer|Lung Cancer|Pancreatic Cancer

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
CELC-G-201

P2

Unknown Status

Prostate Cancer

2027-03-31

CELC-G-301

P3

Unknown Status

Breast Cancer

2026-09-18

CELC-G-201

P2

Recruiting

Prostatic Diseases|Urogenital Cancer|Prostate Cancer

2025-11-01

VIKTORIA-1

P3

Recruiting

Breast Cancer

2025-09-30

40%

Recent News Events

Date

Type

Title

11/12/2024

News Article

 Celcuity Inc. To Present at Upcoming Stifel and Jefferies Investor Conferences

11/07/2024

News Article

 Celcuity Inc. Schedules Release of Third Quarter 2024 Financial Results and Webcast/Conference Call

08/07/2024

News Article

 Celcuity Inc. Schedules Release of Second Quarter 2024 Financial Results and Webcast/Conference Call

06/03/2024

News Article

 Celcuity To Participate in Jefferies Global Healthcare Conference

04/10/2024

PubMed

 Method development and validation for the estimation of gedatolisib in mouse plasma by tandem mass spectrometry and its application to pharmacokinetics studies.

04/01/2024

PubMed

 Gedatolisib in combination with palbociclib and endocrine therapy in women with hormone receptor-positive, HER2-negative advanced breast cancer: results from the dose expansion groups of an open-label, phase 1b study.

01/01/2024

PubMed

 Prediction of Prognostic Features Based on Neutrophil-Related Genes for Lung Squamous Cell Carcinoma Reveals Immune Landscape and Drug Candidates.

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