Revtorpyk

(Gedatolisib)

Phase 3Small molecule

CCelcuity Inc

Revtorpyk is one of 114 small molecule programs targeting Breast Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

113

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Breast CancerActive, not recruiting

Prostate CancerRecruiting

Endometrial CancerRecruiting

Breast CancerPhase 3

Active, not recruiting

Prostate CancerPhase 2

Recruiting

Endometrial CancerPhase 2

Recruiting

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Revtorpyk

CCelcuity Inc

Phase 3

5 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Blenoxane

Bristol-Myers Squibb

Preclinical

1 5

Duragesic-100

CCephalon

Preclinical

2 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 7

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 8

Tricor

JJagotec

Preclinical

1 9

Cortef

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

Preclinical

1 10

Feraheme

AAzurity Pharmaceuticals

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Breast Cancer

NCT05501886

Q4 2027

Phase 1/2Recruiting

Prostate Cancer

NCT06190899

Q3 2031

Phase 2Recruiting

Endometrial Cancer

NCT03675893

Clinical

Trials by Indication[1]

Breast Cancer5 trials

A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer

Completed·CCelcuity Inc·Phase 1·NCT02684032·141 enrolled

Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers

Active, not recruiting·KKari Wisinski·Phase 1/2·NCT03911973·37 enrolled

Phase I Study of Combination of Gedatolisib With Palbociclib and Faslodex in Patients With ER+/HER2- Breast Cancer

Unknown status·HHoffman Oncology·Phase 1·NCT02626507·18 enrolled

Show 2 more trials

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

Active, not recruiting·CCelcuity Inc·Phase 3·NCT05501886·701 enrolled

Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer ("GLACIER")

Withdrawn·—·Phase 1/2·NCT03400254

Prostate Cancer1 trial

Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer

Recruiting·CCelcuity Inc·Phase 1/2·NCT06190899·54 enrolled

Advanced or Metastatic NSCLC1 trial

Study of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002)

Terminated·UUniversity of Florida·Phase 1/2·NCT02920450·3 enrolled

ESS1 trial

Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009

Available·CCelcuity Inc··NCT05134922

Other Solid Tumors1 trial

Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors

Suspended·—·Phase 1·NCT03065062·75 enrolled

2 more indications

Triple-Negative Breast Cancer1 trial

An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer

Completed·KKathy Miller·Phase 1·NCT03243331·18 enrolled

Endometrial Cancer1 trial

RESOLVE: A Multi-Cohort Phase 2 Study of Letrozole/Abemaciclib Alone and in Combination With Metformin and Gedatolisib

Recruiting·DDana-Farber Cancer Institute·Phase 2·NCT03675893·110 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 13, 2026

REVTORPYK

NDA NDA219908

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Gedatolisib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Gedatolisib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Gedatolisib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA219908). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Celcuity Inc company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: CCelcuity Inc

Revtorpyk

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q3 2031

Trials by Indication[1]

Breast Cancer5 trials

Prostate Cancer1 trial

Advanced or Metastatic NSCLC1 trial

ESS1 trial

Other Solid Tumors1 trial

Triple-Negative Breast Cancer1 trial

Endometrial Cancer1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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