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Raloxifene- Usual

Phase 2

Breast Cancer | Small molecule | Oncology |Design Therapeutics, Inc.|Last Updated: Apr 23, 2026

Target and mechanism

ModalitySmall molecule

Also known as Raloxifene - Usual

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment600

FDA Designations

No designations recorded

Clinical trial landscape

Raloxifene- Usual · 1 trial · 1 indication

Phase 2 1
NCT06062810Bioequivalence ANDA SNP Clinical Study - Raloxifene and Single Nucleotide PolymorphismsBreast Cancer
ACTIVE NOT_RECRUITING600 Analytics
PHASE2ACTIVE NOT_RECRUITING
Bioequivalence ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Measure and Report Raloxifene oncology drug target ER SNP Genotypes which are effectiveness associated.
Up to 12 weeks

* Recruit 300 double blind random group separated Breast Cancer LCIS patients currently using the Chemotherapy dose on Generic-1 - raloxifene (60mg x 2 orally daily), after breast tissue biopsy, to be the usual approach group. * Recruit 300 double blind random group separated Breast Cancer LCIS patients currently using the Chemotherapy dose on Generic-2 - raloxifene (60mg x 2 orally daily), after breast tissue biopsy, to be the study approach group. * Measure above every BC-LCIS patient specific Raloxifene oncology drug target ER SNP genotype in Breast Cancer cell whole genome DNA with Oxford precisely sequencing. * Report every BC-LCIS patient specific ER SNP genotype in whole genome DNA sequence.

Measure and Report Raloxifene oncology drug target UGT SNP Genotypes which are risk associated.
Up to 12 weeks

* Recruit 300 double blind random group separated Breast Cancer LCIS patients currently using the Chemotherapy dose on Generic-1 - raloxifene (60mg x 2 orally daily), after blood draw, to be the usual approach group. * Recruit 300 double blind random group separated Breast Cancer LCIS patients currently using the Chemotherapy dose on Generic-2 - raloxifene (60mg x 2 orally daily), after blood draw, to be the study approach group. * Measure above every BC-LCIS patient specific Raloxifene oncology drug target UGT SNP genotype in WBC cell whole genome DNA with Oxford precisely sequencing. * Report every BC-LCIS patient specific UGT SNP genotype in whole genome DNA sequence.

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeHEALTH_SERVICES_RESEARCH

Treatment Arms

ArmTypeDescription
Raloxifene - UsualEXPERIMENTAL* Generic-1 - Raloxifene * Chemotherapy * Generic-1 - raloxifene hydrochloride tablet * Raloxifene 60 mg x 2 taken orally daily * Usual Approach Group (Generic-1)
Raloxifene - StudyEXPERIMENTAL* Generic-2 - Raloxifene * Chemotherapy * Generic-2 - Raloxifene Hydrochloride Tablet * Raloxifene 60 mg x 2 taken orally daily * Usual Approach Group (Generic-2)

Interventions

NameTypeDescription
Raloxifene - UsualDRUG* Generic-1 - raloxifene hydrochloride tablet * Raloxifene 60 mg x 2 taken orally daily
Raloxifene - StudyDRUG* Generic-2 - Raloxifene Hydrochloride Tablet * Raloxifene 60 mg x 2 taken orally daily
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Eligibility Criteria

Age Range24 Years to 64 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

* Select 600 Breast Cancer LCIS Patients who are suitable for breast tissue biopsy * High risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (LCIS) * Dosage Duration at least 90 days * The usual approach group - Recruit 300 double blind random group sepa...

Countries:United States
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Competitive Landscape -Breast Cancer 402 trials

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 Raloxifene- Usual

What is Raloxifene - Usual used for in Breast Cancer?

Raloxifene - Usual is an investigational small molecule being studied for use in breast cancer. It is currently in Phase 2 clinical development. The drug is being evaluated in a controlled, randomized, double-blind clinical trial enrolling 600 female participants in the United States.

Who is developing Raloxifene - Usual?

Raloxifene - Usual is being developed by Design Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker DSGN. The company is conducting a Phase 2 clinical trial of the drug for breast cancer.

What phase is Raloxifene - Usual in?

Raloxifene - Usual is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is active but not recruiting participants.

What clinical trials is Raloxifene - Usual in?

Raloxifene - Usual is being studied in one active Phase 2 clinical trial with the identifier NCT06062810. The trial, titled "Bioequivalence ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms," is enrolling 600 female participants with breast cancer in the United States.

Is Raloxifene - Usual the same as Raloxifene - Usual?

Yes, Raloxifene - Usual is also known as Raloxifene - Usual. Both names refer to the same investigational drug being developed by Design Therapeutics, Inc. for the treatment of breast cancer.