A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF VEPDEGESTRANT (PF-07850327) IN ADULT PARTICIPANTS WITH MODERATE AND SEVERE HEPATIC IMPAIRMENT RELATIVE TO HEALTHY PARTICIPANTS WITH NORMAL HEPATIC FUNCTION

The purpose of the study is to look at how the body processes a study medicine called vepdegestrant in participants with loss of liver function relative to people with normal liver function.
This study is seeking participants who are:
* females who cannot have children or males
* between 18 and 70 years of age
* weigh more than 50 Kilograms (110 pounds)
* either healthy with normal liver function or have loss of liver function
All participants in this study will take one dose of vepdegestrant by mouth. This study looks at how the medicine is changed and removed from the body after being taken by the participants. The amount of vepdegestrant in participants with loss of liver function will be compared to the amount of vepdegestrant in participants with normal liver function.
All participants will stay at the study clinic for about 11 days and 10 nights.

Start Date18 Nov 2025

Sponsor / Collaborator

Pfizer Inc.

[+1]

NCT06911788

/ CompletedPhase 1

A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD, SINGLE-DOSE, CROSS-OVER STUDY TO ESTIMATE THE ABSOLUTE BIOAVAILABILITY OF VEPDEGESTRANT (ARV-471, PF-07850327) FOLLOWING ORAL AND INTRAVENOUS DOSING OF THE DRUG TO HEALTHY PARTICIPANTS

The purpose of this study is to learn how much of the study medicine called Vepdegestrant will reach the bloodstream when given orally compared to given intravenously.
This study is seeking participants who:
* are healthy males and healthy females who cannot have children.
* are 18 years or older.
* are healthy as decided by medical tests.
* have a body mass index (BMI) of 16 to 32 kilogram per meter squared.
* have a total body weight of more than 45 kilograms (99 pounds).
In Period 1, all participants will receive one dose of Vepdegestrant by IV. In Period 2, all participants will receive one dose of Vepdegestrant by mouth following a high-fat breakfast. The levels of Vepdegestrant in Period 1 will be compared to the levels of Vepdegestrant in Period 2 and the bioavailablility of the oral formulation of Vepdegestrant will be determined.
The study duration is 22 days and includes two periods. Participants will stay in the clinical research unit for 9 days (8 nights) during each period. A follow-up visit for each participant takes place at 28 to 35 days after taking the study medicine for the last time.

Start Date03 Apr 2025

Sponsor / Collaborator

Pfizer Inc.

[+1]

NCT06645938

/ CompletedPhase 1

A PHASE I, RANDOMIZED, OPEN-LABEL, 2-PERIOD, 2-TREATMENT, 2-SEQUENCE, CROSSOVER, SINGLE-DOSE STUDY IN HEALTHY ADULT PARTICIPANTS TO ESTIMATE THE BIOAVAILABILITY OF AN VARIANT (HIGH HARDNESS) TABLET OF VEPDEGESTRANT (ARV-471, PF-07850327) RELATIVE TO THE REGISTRATIONAL TABLET

The purpose of the study is to compare the amount vepdegestrant available from two different tablet formulations under fed conditions in healthy adult participants; 200 mg vepdegestrant alternative tablet formulation compared to 200 mg vepdegestrant standard tablet formulation.
This study is seeking male or female participants of non-childbearing potential age who:
* are 18 years or older
* are healthy as decided by medical tests.
* have a Body mass index (BMI) of 16 to 32 kilogram per meter squared; and a total body weight of more than 45 kilograms (99 pounds).
All participants will be put into groups to receive one of the 2 treatments in each period. This study will consist of 2 treatment sequences:
* Sequence 1: Single 200 mg dose of vepdegestrant registrational tablet in Period 1, followed by a single 200 mg dose of vepdegestrant variant tablet in Period 2.
* Sequence 2: Single 200 mg dose of vepdegestrant variant tablet in Period 1, followed by a single 200 mg dose of vepdegestrant registrational tablet in Period 2.
Participants will be in the study for about 11 weeks.

Start Date16 Oct 2024

Sponsor / Collaborator

Pfizer Inc.

[+1]

100 Clinical Results associated with Vepdegestrant

100 Translational Medicine associated with Vepdegestrant

100 Patents (Medical) associated with Vepdegestrant

Literatures (Medical) associated with Vepdegestrant

27 Mar 2026·ChemMedChem

Insights Into Vepdegestrant (ARV‐471): The First‐in‐Class Estrogen Receptor Proteolysis‐Targeting Chimera Approaching Food and Drug Administration Approval for Breast Cancer

Review

Author: Tian, Bin ; Wang, Wen ; Wei, Meiyan ; Tang, Chao ; Ke, Changhua ; Zhang, Yunfei ; Zhang, Qiannan ; Wang, Mengzhou ; Deng, Xintao ; He, Meiling ; Xia, Juan ; Tian, Lei ; Chen, Mengxin ; Zhang, Bingxing ; Liang, Chengyuan

Vepdegestrant (ARV‐471) is an orally bioavailable, proteolysis‐targeting chimera (PROTAC)‐based estrogen receptor (ER) degrader and is among the most clinically advanced ER‐targeting PROTAC degraders, identified through a rational medicinal chemistry optimization campaign. It is being developed as an oral small‐molecule endocrine therapy for advanced or metastatic ER‐positive, human epidermal growth factor receptor 2 (HER2)‐negative breast cancer, with particular relevance for tumors harboring ESR1 mutations. On June 6, 2025, Arvinas and Pfizer submitted a New Drug Application (NDA) for vepdegestrant to the U.S. Food and Drug Administration (FDA), representing an important step in the clinical translation of PROTAC technology. This review summarizes the design, synthesis, degradation mechanism, preclinical pharmacology, and clinical development of vepdegestrant and discusses the broader implications and future prospects of oral PROTAC‐based ER degraders in breast cancer therapy.

01 Mar 2026·CLINICAL THERAPEUTICS

Letter to the Editor Regarding “The Effect of Itraconazole on the Pharmacokinetics of Vepdegestrant, a PROteolysis TArgeting Chimera Estrogen Receptor Degrader, in Healthy Adult Participants” Recently Published by Tran and Colleagues

Letter

Author: Dahlgren, David ; Lennernäs, Hans ; Niessen, Janis

01 Feb 2026·CLINICAL THERAPEUTICS

The Effect of Itraconazole on the Pharmacokinetics of Vepdegestrant, a PROteolysis TArgeting Chimera Estrogen Receptor Degrader, in Healthy Adult Participants

Article

Author: Stouffs, Alexandre ; Tran, Lana ; Tan, Weiwei ; Lee, Kimberly C ; Zhang, Yuanyuan ; Matschke, Kyle T ; Winton, Jennifer A

PURPOSE:

Vepdegestrant (ARV-471) is an orally administered PROteolysis TArgeting Chimera estrogen receptor (ER) degrader that directly binds an E3 ligase and ER to trigger ubiquitination and subsequent proteasomal degradation of ER. Based on findings from a first-in-human phase 1/2 trial, vepdegestrant 200 mg once daily was selected as the recommended phase 3 dose and was evaluated in the phase 3 clinical study VERITAC-2 (NCT05654623) for the treatment of patients with ER-positive human epidermal growth factor receptor 2-negative breast cancer. Vepdegestrant is a substrate of cytochrome P450 (CYP)3A4 in vitro; therefore, its plasma exposure may increase when coadministered with CYP3A4 inhibitors, such as the strong index CYP3A4 inhibitor itraconazole. This study evaluated the effect of itraconazole on the pharmacokinetics (PK) and safety of vepdegestrant in healthy adults.

METHODS:

During this phase 1, open-label, 2-period, fixed-sequence study (NCT05538312), participants received 2 doses of vepdegestrant and multiple doses of itraconazole. In period 1, participants received a single dose of vepdegestrant 200 mg under fed conditions followed by a washout period of at least 10 days. In period 2, participants received itraconazole 200 mg once daily under fasted conditions on days 1-11 and a single dose of vepdegestrant 200 mg under fed conditions on day 5 with concomitant itraconazole administration. Plasma samples were collected predose and serially following each vepdegestrant dose. PK parameters calculated for vepdegestrant and its epimer metabolite, ARV-473, included area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC_inf) and maximum plasma concentration (C_max). Safety was monitored throughout the study.

FINDINGS:

A total of 12 healthy adult participants received vepdegestrant with (test) and without (reference) itraconazole. The vepdegestrant test/reference ratios of the adjusted geometric means (90% confidence intervals) for AUC_inf and C_max were 168.9% (157.7-180.9) and 152.2% (136.9-169.2), respectively. Similar increases in exposure were observed for ARV-473. All adverse events were mild or moderate, and no participants discontinued from the study due to adverse events.

IMPLICATIONS:

Coadministration of multiple doses of itraconazole, a strong CYP3A4 inhibitor, increased vepdegestrant exposure by 69%, suggesting the involvement of CYP3A4-mediated metabolism, albeit not predominantly, in vepdegestrant elimination.

152

News (Medical) associated with Vepdegestrant

22 May 2026

·endpoints.news

Ibrance's would-be successors, the data that helped sell Tubulis to Gilead, and more at ASCO

All of the regular ASCO abstracts dropped Thursday afternoon, with the biggest news coming from the VEGF bispecific race , Merck and Kelun-Biotech’s TROP2 ADC known as sac-TMT, and multiple head and neck cancer updates . But there were plenty of other developments across cancer trials and new mechanisms, and we’ve rounded up the best of the rest here. Find updates below on potential successors for Pfizer’s blockbuster Ibrance, the Tubulis data that got Gilead Sciences excited enough to buy it out, and more. Both Pfizer and BeOne Medicines (formerly BeiGene) are developing CDK4 inhibitors in a bid to take up Ibrance’s mantle in breast cancer, as the first Ibrance biosimilars are expected as soon as next year. For Pfizer, the successor is called atirmociclib. The drugmaker toplined a separate Phase 2 success earlier this year in HR-positive, HER2-negative breast cancer, but an abstract released Thursday supplemented those results. Patients received either a combination of atirmociclib and an aromatase inhibitor called letrozole, or letrozole alone. Efficacy was measured with an endpoint called “complete cell cycle arrest,” or CCCA, which examines how quickly patients’ tumor cells stopped dividing. After 14 days, 45 of 51 patients (88.2%) who took the combination regimen saw their cell division slow by a meaningful amount, compared to 10 of 56 (17.9%) who only received letrozole. The data come from patients with advanced breast cancer who progressed after treatment with a CDK4/6 inhibitor (including Ibrance). Pfizer enrolled patients whose tumor cells were dividing rapidly. BeOne, meanwhile, is researching a program called BGB-43395 and reported data from a safety expansion cohort of a Phase 2 study, also looking at a combination with letrozole. The company has enrolled 58 patients so far across three dosing regimens. After a median follow-up of 6.8 months, the median time-to-response was 3.6 months and progression-free survival was not reached. Unlike these experimental drugs, Ibrance is a CDK4/6 inhibitor. Global Ibrance sales peaked in 2022 with $5.12 billion. In 2025, Ibrance was selected for the second round of price negotiations under the Inflation Reduction Act, with new prices expected to be implemented for patients with Medicare starting next year. Gilead paid $3.15 billion upfront last month to acquire the ADC-focused biotech Tubulis, and an ASCO abstract released Thursday attempts to show why. The biotech’s lead program is called TUB-040, a NaPi2b-directed ADC that is in testing for certain forms of ovarian cancer and non-small cell lung cancer. Tubulis administered the drug to patients with platinum-resistant ovarian cancer across four dose levels in a Phase 1/2a study, 46 of whom could be evaluated for efficacy. Of those 46 patients, 28 saw their tumors shrink by at least 30%, good for a confirmed objective response rate of 60.9%. Responses were spread almost evenly across all dose levels, with seven patients responding in each of the two lowest doses, eight responding in the third level and six responding at the highest dose. Gilead and Tubulis initially signed a partnership in 2024 before this year’s buyout. Gilead could pay another $1.85 billion if all milestones in the deal are met. Earlier this month, the FDA approved Pfizer and Arvinas’ drug vepdegestrant (brand name: Veppanu) for patients with a certain form of breast cancer. But it’s unclear how many patients will take it, and the companies shipped the drug’s rights to Rigel Pharmaceuticals for $70 million upfront — a fraction of the $1 billion Pfizer initially paid for the partnership. Data released Thursday from a Phase 1b/2 study continued to illustrate why the drug has disappointed. In second-line patients with certain ER-positive/HER2-negative breast cancers, Veppanu plus an aromatase inhibitor induced responses in just eight of 33 patients at the highest dose measured (24.2% confirmed ORR). Only five of 31 who received the low dose responded to the therapy. Response rates were lower in patients with ESR1 mutations, with three of 14 patients (21.4%) responding to the high dose. These mutations are where the expected competition of oral SERDs has largely been a success. Pfizer and Arvinas presented Phase 3 data for the drug at last year’s ASCO, showing it was no better than oral SERDs. AstraZeneca’s B7-H4 ADC: The drug is called puxitatug samrotecan, or puxi-sam. At its low dose, 14 of 31 patients with endometrial cancer (34.1% ORR) and four of 33 with ovarian cancer (12.1% ORR) saw their tumors shrink by at least 30%. At the high dose, 24 of 50 endometrial cancer patients (48% ORR) and 11 of 45 individuals with ovarian cancer (24.4% ORR) saw the same level of tumor shrinkage. Median PFS in endometrial cancer was 8.1 months and seven months at the high and low doses, respectively. In ovarian cancer, median PFS was 5.7 months at the high dose and 4.8 months at the low dose. Additionally, the company released very early data from a cohort looking at patients with biliary tract cancer. After a median follow-up of 2.2 months, two of 20 patients saw their tumors shrink by at least 30%, good for an ORR of 10%. The company hopes more patients will respond after longer periods of time. Immuneering posts more pancreatic cancer results: The biotech rolled out another update for its oral MEK inhibitor atebimetinib, after multiple positive updates in the last 12 months measuring it in combination with chemotherapy. After a median follow-up of 10.4 months, median PFS was 8.4 months and median overall survival was not reached among 50 patients. Six- and nine-month OS rates were 88% and 79%, respectively. AstraZeneca’s Neogene data: The first data from AstraZeneca’s 2022 buyout of Neogene were released Thursday, showing results from the NT-175 program in patients with TP53 mutations in solid tumors. Investigators said 10 of 21 patients who received the therapy responded after a median six months of follow-up. This included five of six patients with pancreatic cancer who took part in the study. NT-175 is an autologous engineered T-cell receptor (eTCR) T cell therapy. Replimune’s three-year survival rates: The company’s therapy RP1, which was rejected twice by the FDA , achieved a three-year OS rate of 45.5% in patients with advanced melanoma. Patients got RP1 along with the anti-PD-1 drug Opdivo after previously failing anti-PD-1 therapy.

Clinical ResultPhase 3Drug ApprovalPhase 2Cell Therapy

14 May 2026

·firstwordpharma.com

Biopharma bites: Rigel buys beleaguered PROTAC, Bayer's pipeline trim, and more from Novo Nordisk, Delos Capital

Rigel gets hands on Pfizer's recently-approved breast cancer drug Bayer cuts early-stage assets from pipeline Superior weight loss in Wegovy HD early responders 'First-of-its-kind' collab aims to incubate new biotechs Rigel gets hands on Pfizer's recently-approved breast cancer drug Having signalled their intent last year to find a US commercialisation partner for vepdegestrant, Pfizer and Arvinas reached an agreement with Rigel Pharmaceuticals on Tuesday to both market and further develop the PROTAC oestrogen receptor (ER) degrader. The deal comes a matter of weeks after the FDA approved the oral drug as Veppanu for ER-positive, HER2-negative, advanced or metastatic breast cancer in adults carrying ESR1 mutations and who have progressed after at least one line of endocrine therapy (see – Spotlight On: Uncertain future resolved for Pfizer and Arvinas' once heavily touted breast cancer drug as Rigel steps in). Under the agreement, Pfizer and Arvinas will receive $85 million in upfront and transition payments, with the potential for a further $320 million in development, regulatory and commercial milestones, plus tiered sales royalties in the mid-teens to mid-20s. All payments from Rigel will be split evenly between the two companies. Pfizer itself had paid Arvinas $650 million upfront in 2021 to co-develop and co-commercialise vepdegestrant, but subsequent clinical readouts narrowed the addressable patient population. For its part, Rigel will own global rights to vepdegestrant, allowing it to sublicense the therapy to potential partners for development and marketing outside of the US. -Matt Dennis Bayer cuts early-stage assets from pipeline As part of its first-quarter earnings report Tuesday, Bayer disclosed that it has cut two Phase I programmes from its pipeline and halted development of Verquvo (vericiguat) in adults with stable chronic heart failure (CHF) and reduced ejection fraction (HFrEF). In September, the pharma, alongside partner Merck & Co., reported that the sGC stimulator — approved in the US and EU for certain patients with worsening CHF — failed to meet its primary endpoint in a Phase III trial for HFrEF. The axed early-stage assets include BAY 2701250, an atrial natriuretic peptide (ANP)-based candidate that was in Phase I testing for pulmonary hypertension. According to ClinicalTrials.gov, the 82-person study finished last May. The third cut programme is BAY 3178275, a Phase I-stage GPR84 antagonist being developed for diabetic neuropathic pain.-Elizabeth Eaton Superior weight loss in Wegovy HD early responders New sub-analyses from the pivotal STEP UP trial show Novo Nordisk's 7.2-mg semaglutide injectable formulation (marketed as Wegovy HD) resulted in a ~28% weight loss among 'early responders' — outclassing the 20.7% reduction originally seen in the wider study. Data presented Tuesday at the European Congress on Obesity (ECO) revealed that early responders — defined as those achieving ≥15% body weight loss within 24 weeks — accounted for 27% of Wegovy HD recipients, compared with 21% for the 2.4-mg dose and 3% on placebo. Novo said that the early responders on Wegovy HD lost on average 27.7% of their weight by week 72, versus. Moreover, a separate MRI sub-analysis with STEP-UP confirmed that 84% of weight lost was attributable to fat mass reduction, including a >30% decrease in abdominal visceral fat, with muscle function largely preserved. For further analysis, see — Spotlight On: Early responder analysis could be useful catalyst for Wegovy HD in US obesity showdown. -Pavan Kamat 'First-of-its-kind' collab aims to incubate new biotechs In what is being touted as a "first-of-its-kind" collaboration, life sciences investment firm Delos Capital is partnering with biopharmaceutical company AP Biosciences to create and incubate new biotechs. The tie-up combines Delos' company-building expertise with APBio's antibody discovery platforms in an effort to accelerate novel medicines through clinical proof of concept. The collaboration will also take advantage of APBio's operational efficiency in Greater China, which the parties noted enables "faster and more capital-efficient translation from innovative concepts to clinical-stage assets." The companies will initially focus on autoimmune diseases using bi- and tri-specific antibody approaches that combine novel and de-risked targets and mechanisms, with Delos — through its Delos Foundry — leading therapeutic ideation, financing and strategic development. "This collaboration allows us to extend the impact of our antibody discovery platforms beyond our internal pipeline," said Jeng Her, APBio's chief executive. Meanwhile, Henry Chen, founder and managing partner of Delos noted that "if we don't see existing companies that match one of our investment theses, our team can fill that gap by incubating innovative assets in a US-based NewCo." -Matt Dennis The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultDrug Approval

12 May 2026

·www.fiercepharma.com

Pfizer, Arvinas win $85M upfront in Rigel licensing pact for new breast cancer med Veppanu

Pfizer and Arvinas had already been scouting for a buyer for breast cancer med Veppanu months before its May 1 FDA approval. Pfizer and Arvinas have landed a buyer for the newly approved breast cancer med Veppanu, selling an exclusive global license to Rigel Pharmaceuticals for $85 million upfront and potentially hundreds of millions more in milestone and royalty payments. The deal includes an initial upfront payment of $70 million, with an added $15 million tied to the completion of certain “development and manufacturing transition activities.” All of the Rigel payments, including up to $320 million in future development, regulatory and commercial milestone payments—plus tiered royalties—will be split evenly between Arvinas and Pfizer. Rigel, a South San Francisco-based pharma that markets a handful of products across oncology and hematologic disorders, was selected to “help unlock the commercial potential of Veppanu and provide access to patients as efficiently as possible,” Arvinas CEO Randy Teel, Ph.D., commented in a company release. Pfizer and Arvinas had already planned on turning the med over to a licensee months before it earned its ahead-of-schedule FDA nod on May 1. The first PROteolysis TArgeting Chimera (PROTAC) therapy to cross the regulatory finish line, Veppanu was approved to treat a narrowed breast cancer population of those who have ER-positive, HER2-negative advanced or metastatic breast cancer with an estrogen receptor 1 (ESR1) mutation following at least one line of endocrine therapy. The indication was born from a phase 3 trial comparing Veppanu to AstraZeneca’s standard of care, Faslodex, which saw the new therapy only able to improve progression-free survival in those with an ESR1 mutation. After axing a pair of combo therapy trials involving Veppanu, former Arvinas CEO John Houston, Ph.D., explained that discussions with health regulators signaled that the treatment would likely be restricted to patients with the specific mutations in the second-line setting.Nonetheless, Rigel sees the licensing deal as a “significant step forward” for its “transformational growth strategy,” allowing it to enter a “targeted segment of the sizable breast cancer market, focused on patients with limited treatment options following progression on endocrine therapy,” CEO Raul Rodriguez said in a press release, adding that the drug is expected to contribute “strong revenue growth” to its commercial portfolio and could become a “meaningful driver of long-term growth.”“With its novel mechanism of action designed to address a key driver of resistance, Veppanu represents a compelling treatment option within this setting," Rodriguez explained. "Importantly, we are well-positioned to advance this important new treatment, supported by a highly experienced commercial and medical affairs organization and a proven track record of successfully launching newly-acquired assets.”Although Arvinas and Pfizer are still responsible for the currently ongoing development activities for the med, Rigel will chip in up to $40 million for these activities. Rigel also has the ability to sublicense commercialization to potential global partners outside of the U.S., with Arvinas and Pfizer in line for a percentage of revenue tied to international sales. Arvinas plans to use its new cash flow to invest in the “next wave of innovation” across its early-stage pipeline, Teel noted. The deal is especially good news for Rigel following a recent breakup with Eli Lilly on what would have been a multi-million-dollar deal surrounding Rigel’s RIPK1 inhibitors. With Lilly fully backing out of the 2021 agreement last month and canceling future payments that could have come from the partnership, Rigel’s income stems mainly from its collection of commercial drugs. The company's marketed products include former Roche and Blueprint Medicines treatment Gavreto, which it bought in 2024, plus Forma Therapeutics-acquired leukemia med Rezlidhia and 2018-approved blood disorder drug Tavalisse. Over the first quarter of 2026, Rigel collected revenues of $58.8 million and $8.7 million in net income after paying $46.9 million in quarterly R&D-related costs and expenses. With the deal, Rigel’s shares were up more than 8% at 11:30 am ET on Tuesday, May 12.

License out/inPhase 3AcquisitionDrug Approval

100 Deals associated with Vepdegestrant

R&D Status

Approved

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Indication	Country/Location	Organization	Date
ER-positive/HER2-negative/ ESR1-mutated breast cancer	United States	Arvinas Operations, Inc.	01 May 2026

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced breast cancer	Phase 3	United States	Arvinas Estrogen Receptor, Inc.	09 Aug 2023
Advanced breast cancer	Phase 3	United States	Pfizer Inc.	09 Aug 2023
Advanced breast cancer	Phase 3	China	Pfizer Inc.	09 Aug 2023
Advanced breast cancer	Phase 3	China	Arvinas Estrogen Receptor, Inc.	09 Aug 2023
Advanced breast cancer	Phase 3	Japan	Pfizer Inc.	09 Aug 2023
Advanced breast cancer	Phase 3	Japan	Arvinas Estrogen Receptor, Inc.	09 Aug 2023
Advanced breast cancer	Phase 3	Australia	Pfizer Inc.	09 Aug 2023
Advanced breast cancer	Phase 3	Australia	Arvinas Estrogen Receptor, Inc.	09 Aug 2023
Advanced breast cancer	Phase 3	Brazil	Arvinas Estrogen Receptor, Inc.	09 Aug 2023
Advanced breast cancer	Phase 3	Brazil	Pfizer Inc.	09 Aug 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AACR2026	Phase 2/3	Hormone receptor positive HER2 negative breast cancer HR Positive \| HER2 Negative	16	Imlunestrant alone	kcqfwgxpra(eudxbitvly) = vfpgtjrqqf fsfccaotws (dxcltzuonp ) View more	Positive	21 Apr 2026
				Camizestrant 75mg	kcqfwgxpra(hkqqogjcnk) = hbqepjphrb kbmqiijxaz (slrxxwibew ) View more
NCT05654623 (VERITAC-2, CTgov)	Phase 3	ER-positive/HER2-negative Breast Cancer	624	fulvestrant	ahdkvaqwsv(jrrgeuidmf) = vvfbhmokou eumiycjokv (cxpbvjvbwj, sqwvphmiwg - nbzfkopjfr) View more	-	03 Feb 2026
NCT04072952 (SABCS2025)	Phase 1/2	ER-positive/HER2-negative Breast Cancer ESR1 mutation	138	Vepdegestrant (ER-positive/HER2-negative advanced breast cancer)	lcvxqmjdts(jolzwaqujv) = xwzlcgwsrk ejnnzzogpf (ekjvziyxtk ) View more	Positive	10 Dec 2025
NCT05549505 (TACTIVE-N, CTgov)	Phase 2	ER-positive/HER2-negative Breast Cancer	152	Surgical resection of breast tumor+ARV-471 (Arm A: ARV-471 (Experimental))	mdootmwhwf = uwbhkpqpfi maoouepupf (mralmhcdhc, rjeiokxbdb - cgodiwymzh) View more	-	29 Aug 2025
				Surgical resection of breast tumor+anastrozole (Arm B: Anastrozole)	mdootmwhwf = soptiwrpdo maoouepupf (mralmhcdhc, yrmbbvivyt - tfnyqdsaic) View more
NCT05654623 (VERITAC-2, Pubmed \| N Engl J Med)	Phase 3	Advanced breast cancer	624	Vepdegestrant 200 mg	opstsmhjkf(jdblspvmfr) = in 2.9% and 0.7% of the patients, respectively yebudvnaou (ncatspyfwy ) View more	Positive	07 Aug 2025
				Fulvestrant 500 mg
NCT05654623 (VERITAC-2, ASCO2025 \| Company_Website) Manual	Phase 3	ER-positive/HER2-negative Breast Cancer ER Positive \| HER2 Negative	624	Vepdegestrant	nyugmmmwpw(vrnkrdrnyo) = ufzuzzytfo pjmbwkdzxb (mbzpufbrwi, 3.6–5.3) View more	Positive	30 May 2025
				fulvestrant	nyugmmmwpw(vrnkrdrnyo) = zuwoafgelu pjmbwkdzxb (mbzpufbrwi, 2.2–3.8) View more
NCT05654623 (VERITAC-2, Company_Website) Manual	Phase 3	ER-positive/HER2-negative Breast Cancer ESR1 Mutation	-	Vepdegestrant (ESR1 mutant)	xqfgzggxcv(nvflevtmsd) = The results exceeded the pre-specified target hazard ratio of 0.60 in the ESR1m population. The trial did not reach statistical significance in improvement in PFS in the intent-to-treat (ITT) population. fdvgkuykmr (biaemyffwz )	Negative	11 Mar 2025
				fulvestrant (ESR1 mutant)
NCT05548127 (TACTIVE-U, GlobeNewswire) Manual	Phase 1	ER-positive/HER2-negative Breast Cancer Third line	16	Vepdegestrant + Abemaciclib	iiizdkksky(mabbonytcp) = None mudjjmkyee (elgdwkpqwj ) View more	Positive	10 Dec 2024
				Vepdegestrant + Abemaciclib (mutant ESR1)
NCT05463952 (Pubmed \| Int J Clin Oncol)	Phase 1	Locally Advanced Unresectable Breast Carcinoma \| Breast Cancer \| Estrogen receptor positive breast cancer ... estrogen receptor (ER) View more	6	Vepdegestrant 200 mg QD	ugdxkmakwb(zsqhsmdwtw) = Four (66.7%) patients experienced adverse events; none led to dose reduction or discontinuation lbqjpuvinu (hzdiikvhsj ) View more	-	20 Nov 2024
NCT05463952 (CTgov)	Phase 1	Locally Advanced Unresectable Breast Carcinoma \| Breast Cancer \| Estrogen receptor positive breast cancer ... View more	6	ARV-471	kebmsyyaba = rrskgratxq osirqjtwrx (svhhxkogok, ncsfdzsvjn - zytnsmpebt) View more	-	23 Sep 2024

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