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ZOLADEX

Phase 1

Advanced Breast Cancer | Small molecule | Oncology |cbdMD, Inc.|Last Updated: Aug 26, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment176

FDA Designations

No designations recorded

Clinical trial landscape

ZOLADEX · 1 trial · 2 indications

Phase 1 1
NCT07310420A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Early-stage and Advanced HR+ Breast CancerAdvanced Breast Cancer
RECRUITING176 Analytics
PHASE1RECRUITING
A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Early-stage and Advanced HR+ Breast Cancer
Advanced Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants with LH Values Below a Specified Threshold at Week 6 Within Each Cohort
Week 6

Secondary Endpoints

Percentage of Participants with LH Values below a Specified Threshold at Weeks 12, 18, and 24 Within Each Cohort
Weeks 12, 18, and 24
Percentage of Participants with Estradiol (E2) Suppression at Weeks 6, 12, 18, and 24 Within Each Cohort
Weeks 6, 12, 18, and 24
Percentage of Participants with Absence of Menses at Weeks 6, 12, 18, and 24 Within Each Cohort
Weeks 6, 12, 18, and 24
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ZOLADEX 10.8 mgEXPERIMENTALParticipants will receive 10.8 mg ZOLADEX on Day 1 and Day 85.

Interventions

NameTypeDescription
ZOLADEXDRUGParticipants will receive ZOLADEX as a subcutaneous (SC) injection on Day 1 (Week 1), and Day 85 (Week 12) for a total of 2 treatments.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexFEMALE
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: 1. Age and gender: Female participants aged 18 to 55 years, inclusive. 2. Hormone receptor positive (HR+): Either estrogen receptor positive (ER+) or progesterone receptor positive (PR+) breast cancer, defined as 1% to 100% of tumor nuclei are positive for ER or PR via immunohis...

Countries:United States
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Competitive Landscape -Breast Cancer 402 trials (matched to "Advanced Breast Cancer")

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about ZOLADEX

What is ZOLADEX used for in advanced breast cancer?

ZOLADEX is being studied for use in advanced breast cancer, specifically in premenopausal women with hormone receptor-positive (HR+) disease. The investigational treatment is evaluated for its ability to achieve ovarian suppression. It is currently in Phase 1 clinical development and remains an investigational drug, not yet approved for this indication.

What does ZOLADEX target?

ZOLADEX is a small molecule designed to suppress ovarian function in premenopausal women. By inducing ovarian suppression, it aims to reduce estrogen production, which can fuel hormone receptor-positive breast cancer growth. The drug is being studied in patients with advanced and early-stage HR+ breast cancer.

Who is developing ZOLADEX?

ZOLADEX is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting a Phase 1 clinical trial to evaluate the drug's effects in premenopausal women with breast cancer.

What phase is ZOLADEX in?

ZOLADEX is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting participants to evaluate ovarian suppression in premenopausal women with early-stage and advanced HR+ breast cancer.

What clinical trials is ZOLADEX in?

ZOLADEX is being evaluated in a single Phase 1 clinical trial with the identifier NCT07310420. This trial, which is currently recruiting, aims to assess ovarian suppression following subcutaneous administration of ZOLADEX 10.8 mg in premenopausal women with early-stage and advanced HR+ breast cancer. The study plans to enroll 176 participants in the United States.

Is ZOLADEX the same as goserelin?

ZOLADEX is a brand name for goserelin, a medication used to suppress ovarian function. In the context of this clinical development program, ZOLADEX is being studied as a subcutaneous injection for ovarian suppression in premenopausal women with HR+ breast cancer. The drug is currently in Phase 1 trials.