Akt inhibitors(Proto-oncogene proteins c-akt inhibitors), PI3K family inhibitors(Phosphatidylinositol 3-kinase family inhibitors), mTORC1 inhibitors(Mammalian target of Rapamycin (mTORC1) inhibitors)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesUrogenital Diseases

Active Indication

Hormone receptor positive HER2 negative breast cancerMetastatic castration-resistant prostate cancerAdvanced Triple-Negative Breast Carcinoma+ [2]

Inactive Indication

Advanced cancerAdvanced Head and Neck CarcinomaAdvanced Lung Squamous Cell Carcinoma+ [14]

Originator Organization

Pfizer Inc.

Active Organization

Celcuity, Inc.

Pfizer Inc.

Inactive Organization-

License Organization

Celcuity, Inc.

Pfizer Inc.

Drug Highest PhaseApproved

First Approval Date

United States (14 Jul 2026),

Hormone receptor positive HER2 negative breast cancer

RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States)

Structure/Sequence

Molecular FormulaC32H41N9O4

InChIKeyDWZAEMINVBZMHQ-UHFFFAOYSA-N

CAS Registry1197160-78-3

Clinical Trials associated with Gedatolisib

NCT06757634

/ RecruitingPhase 3

VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Gedatolisib With Endocrine Therapy and Palbociclib vs Endocrine Therapy and Ribociclib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.

Start Date24 Jul 2025

Sponsor / Collaborator

Celcuity, Inc.

NCT06190899

/ RecruitingPhase 1/2

A Phase 1/2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

This is a Phase 1/2, open-label, randomized, dose finding and dose expansion study to evaluate the safety, preliminary efficacy, and PK of gedatolisib in combination with darolutamide in subjects with mCRPC.

Start Date01 Jan 2024

Sponsor / Collaborator

Celcuity, Inc.

NCT05501886

/ Active, not recruitingPhase 3

Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.

Start Date08 Dec 2022

Sponsor / Collaborator

Celcuity, Inc.

100 Clinical Results associated with Gedatolisib

100 Translational Medicine associated with Gedatolisib

100 Patents (Medical) associated with Gedatolisib

125

Literatures (Medical) associated with Gedatolisib

01 Sep 2026·DRUGS

Emerging Strategies Targeting the PI3K/AKT/mTOR Pathway in HR+/HER2– Advanced Breast Cancer

Review

Author: Gandhi, Shipra ; Kalinsky, Kevin ; Canning, Madison ; Sakach, Elizabeth ; Kamga, Larisa ; Lei, Lan ; Abid, Minaam ; Lateef, Almeera

Hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer accounts for approximately 70% of breast cancer cases. Despite recent advances with cyclin-dependent kinase 4/6 inhibitors (CDK4/6i), resistance inevitably develops, often driven by activation of the phosphatidylinositol 3-kinase (PI3K)-AKT-mammalian target of rapamycin (mTOR) pathway. Genetic alterations such as PIK3CA mutations (present in ~ 45% of HR+/HER2- tumors), AKT1 mutations, and PTEN loss contribute to endocrine resistance and poor outcomes. This review summarizes emerging strategies targeting this pathway to overcome resistance in advanced disease. Isoform-specific PI3K inhibitors, including alpelisib and inavolisib, have demonstrated clinically meaningful progression-free survival benefits in PIK3CA-mutated populations, with inavolisib showing improved tolerability and efficacy. In contrast, pan-PI3K inhibitors such as buparlisib have been constrained by toxicity. Targeting downstream signaling, AKT inhibitors have also shown benefit: capivasertib has demonstrated clinical efficacy leading to US Food and Drug Administration approval, while ipatasertib has yielded encouraging results, particularly in tumors harboring PIK3CA, AKT1, or PTEN alterations. Mammalian target of rapamycin inhibitors, notably everolimus, have shown efficacy irrespective of mutation status. The dual PI3K-mTOR inhibitor (gedatolisib) has also shown promising progression-free survival benefit in a PIK3CA wild-type population. Next-generation agents, including mutant-selective PI3Kα inhibitors and bi-steric mTOR complex 1 inhibitors, are under active investigation. Optimal sequencing of these agents alongside endocrine therapy and CDK4/6i options remain a critical question, as does integration of genomic testing to guide therapy. Future directions include rational combination strategies, improved biomarker-driven selection, and novel modalities such as proteolysis-targeting chimeras (PROTACs). Collectively, these advances aim to enhance durability of response, minimize toxicity, and improve survival in HR+/HER2- metastatic breast cancer.

01 Sep 2026·ESMO Open

Corrigendum to ‘Phase II study of trastuzumab-pkrb plus gedatolisib in patients with HER2-positive metastatic breast cancer who progressed after two or more HER2-directed therapies’

Author: Kim, J H ; Bae, J ; Kim, H J ; Ko, S ; Lee, G W ; Jung, J Y ; Kim, J E ; Lee, E M ; Kwon, J H ; Oh, S Y ; Kim, J W ; Park, S ; Kang, M J ; Choi, J Y ; Ahn, H K ; Lee, K-H ; Park, K U ; Park, J H ; Kim, T H ; Chae, Y S ; Chae, H ; Park, Y H ; Lee, K E ; Park, I H ; Byun, J H ; Lee, S ; Ha, J Y ; Park, K H ; Kim, M H

01 Jul 2026·ESMO Open

Phase II study of trastuzumab-pkrb plus gedatolisib in patients with HER2-positive metastatic breast cancer who progressed after two or more HER2-directed therapies

Article

Author: Bae, J ; Kim, J H ; Kim, H J ; Ko, S ; Lee, G W ; Jung, J Y ; Kim, J E ; Lee, E M ; Kwon, J H ; Oh, S Y ; Kim, J W ; Park, S ; Kang, M J ; Ahn, H K ; Choi, J Y ; Lee, K-H ; Park, K U ; Park, J H ; Chae, Y S ; Kim, T H ; Park, Y H ; Chae, H ; Park, I H ; Lee, K E ; Byun, J H ; Lee, S ; Ha, J Y ; Park, K H ; Kim, M H

BACKGROUND:

To evaluate the activity and safety of trastuzumab-pkrb plus gedatolisib in patients with treatment-refractory human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) harboring phosphatidylinositol 3-kinase (PI3K) pathway alterations.

PATIENTS AND METHODS:

In this multicenter, single-arm phase II study, eligible patients had HER2-positive MBC with PI3K pathway aberrations identified by tumor or circulating cell-free DNA and had progressed after at least two prior HER2-directed therapies. Patients received trastuzumab-pkrb (8 mg/kg loading dose, then 6 mg/kg IV every 3 weeks) plus gedatolisib (180 mg IV on days 1, 8 and 15 of each 21-day cycle). The primary endpoint was objective response rate (ORR), 90% power with one-sided 5% type I error, assuming a 25% target for the combination therapy. The trial closed early after 44 patients due to changes in regulatory sponsorship.

RESULTS:

PI3K pathway alterations included PIK3CA kinase domain mutations (59%), helical domain mutations (25%), and PTEN deletions (5%). The ORR was 43.2% [95% confidence interval (CI) 28.3%-59.0%], with two complete and 17 partial responses. Disease control rate was 86.4%. Median progression-free survival (PFS) was 6.01 months (95% CI 5.03-7.69), and median overall survival (OS) was 24.74 months (95% CI 17.28-NA) after 32.05 months of follow-up. Oral mucositis (90.9%; 15.9% grade ≥3) and hyperglycemia (25.0%; 2.3% grade 3) were most frequent, and no treatment-related deaths occurred. Early circulating tumor DNA dynamics predicted PFS and OS.

CONCLUSION:

Trastuzumab-pkrb plus gedatolisib demonstrated a 43.2% response rate and manageable toxicity, supporting dual HER2/PI3K pathway targeting in heavily pretreated HER2-positive MBC.

133

News (Medical) associated with Gedatolisib

06 Oct 2026

·firstwordpharma.com

KymaThera nabs $80M to move PI3Kα inhibitor into the clinic

KymaThera closed an $80-million series B on Tuesday to fill what it sees as a PI3Kα-sized hole in cancer care, despite several approved treatments. The round, led by Alta Partners, builds on the biotech's 2024 series A and brings its total capital raised to date to more than $100 million. Other investors in the latest financing include Venrock, Foresite Capital and J. Wood Capital. "PI3Kα is one of the most important, well-validated, and heavily pursued disease drivers in oncology, but its therapeutic potential has been constrained by wild-type PI3Kα-mediated toxicity and incomplete coverage of clinically relevant mutations," KymaThera CEO Rob Kania said in a company release. "Our drug design objective from the outset was to address these limitations."At least three PI3Kα-targeting treatments are approved in the US, including Novartis' Piqray (alpelisib) and Roche's Itovebi (inavolisib), both cleared for HR-positive, HER2-negative breast cancer patients with a PI3KCA mutation. Celucity's Revtorpyk (gedatolisib), a comprehensive inhibitor of the PI3K/AKT/mTOR (PAM) pathway, was greenlit by the FDA in July for patients with HR-positive, HER2-negative breast cancer who lack a PIK3CA mutation. In addition to Piqray, Novartis recently upped its commitment to the target by splashing $2 billion upfront to buy Pikavation Therapeutics and its portfolio of pan-mutant selective PI3Kα inhibitor programmes. 'Class-leading potency'KymaThera plans to use the fresh funding to move its lead candidate K-1728 into Phase I testing this quarter and advance it through initial clinical proof-of-concept. Initially, the biotech said it plans to develop the oral, pan-mutant selective PI3Kα inhibitor as a monotherapy and in combination regimens for HR-positive, HER2-negative breast cancer, "where substantial unmet need remains despite available therapies." It will also explore K-1728's potential to treat PI3Kα-driven vascular malformations as a monotherapy. Leveraging its structure-based drug discovery technology, KymaThera designed K-1728 to address the limitations of first-generation PI3Kα inhibitors by blocking disease-driving kinase and helical domain mutations while preserving wild-type PI3Kα.KymaThera said that in preclinical studies using models with both kinase and helical domain PI3Kα mutations, low, once-daily doses of K-1728 led to tumour regressions. "K-1728 possesses class-leading potency with helical mutant selectivity windows wider than any reported to date," Kania said.

Drug ApprovalPhase 1Acquisition

05 Oct 2026

·www.biospace.com

Celcuity Announces Multiple Presentations At The European Society For Medical Oncology (ESMO) Congress 2026

Rapid oral presentation of additional sub-group analyses from the VIKTORIA-1 PIK3CA mutant-type cohort Poster presentation of a comparative analysis of data for the gedatolisib triplet from the PIK3CA wild-type cohort of VIKTORIA-1 and other regimens evaluated in patients with HR+/HER2- advanced breast cancer Poster presentation of sub-group analyses from the Phase 1b trial of gedatolisib plus darolutamide in patients with mCRPC MINNEAPOLIS, Oct. 05, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced that a late breaking rapid oral presentation and three poster presentations will be featured at the upcoming European Society for Medical Oncology (“ESMO”) Congress 2026 being held October 23-27, 2026, in Madrid, Spain. Data from its clinical trials of gedatolisib in hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”) locally advanced or metastatic breast cancer (“ABC”) and metastatic castration-resistant prostate cancer (“mCRPC”) will be presented. Late Breaking Rapid Oral Presentation Details: Title: VIKTORIA-1: Updated results of a randomized, open-label, phase 3 study of gedatolisib (geda) + fulvestrant (fulv) ± palbociclib (palbo) vs standard of care in patients with HR+/HER2- advanced breast cancer (ABC) (Study 2) Presentation Number: LBA 16 Speaker: Barbara Pistilli, MD Session Title: Rapid oral 1: Breast cancer, advanced stage Room: Almeria Auditorium - Hall 9 Date: Saturday, October 24, 2026 Time: 10:15 –11:45 a.m. CEST Poster Presentation Details: Title: A phase 1/2, open-label, randomized, dose-finding and dose expansion study of gedatolisib in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC) Presentation Numbe r : 2237P Presenting Author: Adam Sharp, MD, PhD Session Title: Poster Display session, Metastatic prostate cancer Date: Friday, October 23, 2026 Time: 3:15 p.m. – 4:00 p.m. CEST Title: Gedatolisib (Ged) vs Other Regimens Post-CDK4/6i and Endocrine Therapy (ET) in PIK3CA Wild-Type (WT) HR+/ HER2- Advanced Breast Cancer (aBC): A Network Meta-Analysis (NMA) Presentation Numbe r : 1873P Presenting Author: Sara Tolaney, MD Session Title: Poster Display session, HR+ breast cancer Date: Saturday, October 24, 2026 Time: 12:00 p.m. – 12:45 p.m. CEST Title: A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Gedatolisib with Endocrine Therapy (ET) and Palbociclib vs ET and Ribociclib as First-Line (1L) Treatment in Patients With HR-Positive (HR+) HER2-Negative (HER2-) Advanced Breast Cancer (ABC) (VIKTORIA-2) Presentation Numbe r : 57TiP Presenting Author: Giuseppe Curigliano, MD, PhD Session Title: Poster Display session, Advanced breast cancer, other Date: Saturday, October 24, 2026 Time: 12:00 p.m. – 12:45 p.m. CEST Abstracts will be published online via the ESMO website at 12:05 a.m. CEST on October 19, 2026. The posters will be presented in the Poster Area – Hall 5. Electronic versions will also be available on the ESMO 2026 virtual platform. About Celcuity Celcuity is a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK™ (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- ABC, supported FDA approval of REVTORPYK for use in patients without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of VIKTORIA-1 have been released. VIKTORIA-2 is an ongoing Phase 3 clinical trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib plus palbociclib plus fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib plus palbociclib plus letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov . Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at . Follow us on LinkedIn and X . Contacts: For Investors: Brian Sullivan, bsullivan@celcuity.com Vicky Hahne, vhahne@celcuity.com (763) 392-0123 For investors and media: Jodi Sievers, jsievers@celcuity.com (415) 494-9924

Phase 1Phase 3Drug ApprovalPhase 2Clinical Result

02 Oct 2026

·www.globenewswire.com

Celcuity Appoints David Gryska To Its Board Of Directors

Mr. Gryska brings decades of strategic and financial leadership experience to Celcuity’s BoardMINNEAPOLIS, Oct. 02, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced the appointment of David W. Gryska to its Board of Directors. Mr. Gryska is a seasoned executive who brings over 35 years of strategic and financial leadership experience in the life sciences industry to Celcuity, including advising early-stage biotechnology companies. “On the heels of our first FDA approval for REVTORPYK™, we are pleased to welcome David to our Board of Directors as we transition into a commercial-stage company,” said Brian Sullivan, Chief Executive Officer and co-founder of Celcuity. “David's extensive experience as a Chief Financial Officer and board member of a number of pharmaceutical companies, through periods of significant clinical development and commercial growth makes him an outstanding addition to our Board. We are confident he will provide valuable expertise as we execute the launch of REVTORPYK, advance our clinical development programs, and continue building the capabilities needed to support long-term growth.” Prior to his retirement, Mr. Gryska served as Executive Vice President and Chief Financial Officer of Incyte Corporation; and Senior Vice President and Chief Financial Officer of Celgene Corporation. Mr. Gryska also served as Senior Vice President and Chief Financial Officer as well as Vice President of Finance and Chief Financial Officer at Scios, Inc. Earlier in his career, Mr. Gryska served as a partner at Ernst & Young LLP in California. Throughout the past 25 years, Mr. Gryska has served on the Boards of eight public biotechnology companies and currently serves on the Board of Directors of Definium Therapeutics. He previously served on the Boards of Directors of Seagen Inc. for more than 15 years, Forte Biosciences, Aerie Pharmaceuticals, and GW Pharmaceuticals. Mr. Gryska holds a B.A. in Accounting and Finance from Loyola University and an MBA from Golden Gate University. “Celcuity is entering an exciting new chapter, with the company poised for significant growth over the next few years following the FDA approval and commercial launch of REVTORPYK in advanced breast cancer,” said Mr. Gryska. “I look forward to supporting Brian and Celcuity’s experienced leadership team as we build on this momentum, advance gedatolisib in additional solid tumor indications, and work to bring meaningful benefits to more patients.” About CelcuityCelcuity is a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluated gedatolisib in combination with fulvestrant, with or without palbociclib, for the treatment of patients with HR+/HER2- ABC. Data from this trial is the basis for FDA approval of REVTORPYK for use in adult patients with HR+/HER2- ABC without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of the VIKTORIA-1 study have been released. Our Phase 3 clinical trial, VIKTORIA-2, is an ongoing trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib in combination with palbociclib and fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib in combination with palbociclib and letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X. Forward-Looking StatementsThis press release contains statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to REVTORPYK and the potential therapeutic benefits of gedatolisib; the size, design and timing of the Company’s clinical trials; the Company’s interpretation of clinical trial data; the status and timing of the submission, and the FDA’s review, of the Company’s supplemental New Drug Application (“sNDA”) for REVTORPYK, and for making comparable filings with other regulatory authorities outside the U.S.; the market opportunity for REVTORPYK; the Company’s expectations regarding the timing of and its ability to commercialize REVTORPYK; the Company’s strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect to gedatolisib, including subcutaneous formulations to support potential future indications for gedatolisib regimens; the Company’s anticipated use of cash; and the strength of its balance sheet. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” "confidence," "encouraged," “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management's current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that the Company’s topline clinical results are based on an ongoing analysis of efficacy and safety data and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in the Company’s clinical trials or the submission, and FDA’s review of, its sNDA for REVTORPYK; the Company’s ability to obtain regulatory approval of its sNDA and maintain regulatory approvals to commercialize REVTORPYK in the U.S. and obtain regulatory approval of gedatolisib outside the U.S., and the market acceptance of REVTORPYK; the development of therapies and tools competitive with gedatolisib; and the Company’s ability to access capital upon favorable terms. In addition, all forward-looking statements are subject to other risks detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as such risks may be updated in its subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. Contacts: Celcuity Inc. Brian Sullivan, bsullivan@celcuity.com Vicky Hahne, vhahne@celcuity.com (763) 392-0123 Jodi Sievers, jsievers@celcuity.com(415) 494-9924

100 Deals associated with Gedatolisib

External Link

KEGG	Wiki	ATC	Drug Bank
D10635	Gedatolisib	-	DB11896

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hormone receptor positive HER2 negative breast cancer	United States	Celcuity, Inc.	14 Jul 2026

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Metastatic castration-resistant prostate cancer	Phase 2	United States	Celcuity, Inc.	01 Jan 2024
Metastatic castration-resistant prostate cancer	Phase 2	France	Celcuity, Inc.	01 Jan 2024
Metastatic castration-resistant prostate cancer	Phase 2	Spain	Celcuity, Inc.	01 Jan 2024
Metastatic castration-resistant prostate cancer	Phase 2	United Kingdom	Celcuity, Inc.	01 Jan 2024
Advanced Triple-Negative Breast Carcinoma	Phase 2	United States	Pfizer Inc.	17 Apr 2019
HER2-negative breast cancer	Phase 2	United States	Pfizer Inc.	17 Apr 2019
Triple Negative Breast Cancer	Phase 2	United States	Pfizer Inc.	17 Apr 2019
Breast cancer recurrent	Phase 2	United States	Pfizer Inc.	26 Feb 2019
Early Stage Breast Carcinoma	Phase 2	United States	Pfizer Inc.	26 Feb 2019
metastatic non-small cell lung cancer	Phase 2	United States	Pfizer Inc.	25 Sep 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


VIKTORIA-1 (ESMO_BC2026)	Phase 3	Advanced breast cancer Second line HR+ \| HER2- \| PIK3CA-Wild Type	325	Gedatolisib + Palbociclib + Fulvestrant	isqdyhmucn(jkikxepxvq) = owwqsmruxu pfdeoegiln (llzkqdrziy )	Positive	07 May 2026
				Gedatolisib + Fulvestrant	isqdyhmucn(jkikxepxvq) = dkkdqshedz pfdeoegiln (llzkqdrziy )
VIKTORIA-1 (ESMO_BC2026)	Phase 3	Advanced breast cancer Second line HR+ \| HER2- \| PIK3CA-Wild Type	392	Gedatolisib + Palbociclib + Fulvestrant	vlesdournw(fgfurgygmy) = sdsrgpqcul slveqlbgln (ooaxafrdrc )	Positive	07 May 2026
				Fulvestrant	vlesdournw(fgfurgygmy) = zyphvqhbgc slveqlbgln (ooaxafrdrc ) View more
NCT05501886 (VIKTORIA-1, Pubmed \| J Clin Oncol)	Phase 3	PIK3CA mutation/HR-positive/HER2-negative Breast Cancer hormone receptor-positive \| HER2− \| PIK3CA wild-type	392	Gedatolisib + Palbociclib + Fulvestrant	wtlztrakmf(icwviesoqv) = vjuwslfffn yyomxwzsaf (wgoujjdohi ) View more	Positive	20 Apr 2026
				Gedatolisib + Fulvestrant	wtlztrakmf(icwviesoqv) = rzdwqjmlmo yyomxwzsaf (wgoujjdohi ) View more
NCT05501886 (VIKTORIA-1, J Clin Oncol \| Biospace) Manual	Phase 3	PIK3CA mutation/HR-positive/HER2-negative Breast Cancer Hormone Receptor–Positive \| HER2− \| PIK3CA Wild-Type	392	gedatolisib+palbociclib+fulvestrant	huwkikzipp(khuwirrfnx) = nsqcjkydfb iszrqymdik (netdqdvult ) Met View more	Positive	09 Mar 2026
				gedatolisib+fulvestrant	huwkikzipp(khuwirrfnx) = qgsrwteaed iszrqymdik (netdqdvult ) Met View more
NCT06190899 (ASCO_GU2026)	Phase 1/2	Metastatic castration-resistant prostate cancer	56	Gedatolisib 120 mg + Darolutamide	gjfaspxvbi(izlyfkmuic) = umaiuoklfx bohtdvculb (ayizrmkcci ) View more	Positive	26 Feb 2026
				Gedatolisib 180 mg + Darolutamide	vychamplvb(vuauypgbcq) = cmaamearnt vuduwoewdd (eraaikvzeq ) View more
VIKTORIA-1 (ESMO2025)	Phase 3	Advanced breast cancer Second line HR+ \| HER2- \| PIK3CA wild-type	392	Gedatolisib + Palbociclib + Fulvestrant	cslcsoqrmi(cbumlnpoat) = subotbegoj xqpwxigczc (fzbzvbiqzb ) View more	Positive	17 Oct 2025
				Gedatolisib + Fulvestrant	cslcsoqrmi(cbumlnpoat) = vbujtvsimg xqpwxigczc (fzbzvbiqzb ) View more
Pubmed \| Clin Cancer Res Manual	Phase 1	Hormone receptor positive HER2 negative breast cancer First line HR+/HER2−	41	Gedatolisib + Palbociclib + Letrozole	jftsnhvfbd(qhvaseeqzu) = mmdrgqzrtm dulharscfz (zcxkdwxbsn ) View more	Positive	20 Aug 2025
NCT05501886 (VIKTORIA-1, PipelineReview \| NEWS) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer HER2 Negative \| HR Positive \| PIK3CA Gene Mutation Negative	-	Gedatolisib Gedatolisib + palbociclib + fulvestrant	zcvchyitpx(fssouwdlko) = wsczpfdoqs fquzkjkfhh (fikvqtyetx ) View more	Positive	28 Jul 2025
				Gedatolisib Gedatolisib + fulvestrant	zcvchyitpx(fssouwdlko) = nkdhnvvqct fquzkjkfhh (fikvqtyetx )
NCT03911973 (Pubmed \| Breast Cancer Res Treat) Manual	Phase 1/2	Advanced Triple-Negative Breast Carcinoma \| BRCA mutation positive Breast Cancer HER2 Negative \| ER Negative \| PR Negative ... View more	-	Gedatolisib + Talazoparib	lqiectbecw(seulwlnvct) = kzqapmsgon btutugvdzn (iyktbxahog ) View more	Negative	05 Jun 2025
NCT06190899 (CELC-G-201, GlobeNewswire \| Company_Website)	Phase 1	Castration-Resistant Prostatic Cancer \| Metastatic castration-resistant prostate cancer Second line \| Third line --	38	Gedatolisib+Darolutamide	tsndrmvgxe(mwkqwawsmi) = ojutzfxehw gomuqvgvtr (bxnzwozdfo )	Positive	01 Jun 2025

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Bio Sequences Search & Analysis

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Chemical Structures Search & Analysis