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REGN5459

Phase 1

Relapsed Multiple Myeloma | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: May 4, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

Clinical trial landscape

REGN5459 · 1 trial · 2 indications

Phase 1 1
NCT04083534First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM)Relapsed Multiple Myeloma
COMPLETED43 Analytics
PHASE1COMPLETED
First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM)
Relapsed Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
Up to 35 Days

Phase 1

Incidence and severity of treatment-emergent adverse events (TEAEs) during REGN5459 treatment period
Up to 12 Weeks After the Last Dose

Phase 1

Incidence and severity of adverse events of special interest (AESI) with REGN5459 treatment period
Up to 12 Weeks After the Last Dose

Phase 1

Objective response rate (ORR) as measured using the International Myeloma Working Group (IMWG) criteria
Up to Approximately 104 Weeks

Phase 2

Secondary Endpoints

Concentrations of REGN5459 in the serum over time
Up to 12 Weeks After the Last Dose
Incidence over time of anti-drug antibodies (ADAs) to REGN5459
Up to 12 Weeks After the Last Dose
Duration of response (DOR) using the IMWG criteria
Up to Approximately 104 Weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
REGN5459EXPERIMENTALCohorts of multiple REGN5459 dose levels

Interventions

NameTypeDescription
REGN5459DRUGAdministered by intravenous (IV) infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status ≤1 * Patients must have myeloma that is response-evaluable according to the 2016 International Myeloma Working Group (IMWG) response criteria * Measurable disease is defined as 1 or more of the following: 1. S...

Countries:United States
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Competitive Landscape -Multiple Myeloma 221 trials (matched to "Relapsed Multiple Myeloma")

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax
Bristol-Myers Squibb CompanyBMY18PHASE3Iberdomide, Lenalidomide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
Johnson & JohnsonJNJ28PHASE3Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Dexamethasone
Regeneron Pharmaceuticals, Inc.REGN11PHASE3Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide
Pfizer Inc.PFE11PHASE3Elranatamab, Lenalidomide
Sanofi SA Sponsored ADRSNY17PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol/ Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040/kg, G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Moderna, Inc.MRNA2PHASE1mRNA-2808
BeOne Medicines Ltd. Sponsored ADRONC1PHASE1Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide
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Frequently asked questions about REGN5459

What is REGN5459 used for?

REGN5459 is an investigational small molecule being developed for the treatment of relapsed multiple myeloma. It is intended for adult patients with relapsed or refractory multiple myeloma, a type of blood cancer that has not responded to or has returned after prior treatment.

Who makes REGN5459?

REGN5459 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The company conducted a first-in-human study of the drug in the United States.

What phase is REGN5459 in?

REGN5459 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in clinical trials.

What clinical trials is REGN5459 in?

REGN5459 has been studied in one clinical trial, identified as NCT04083534. This was a first-in-human, Phase 1 study in adult patients with relapsed or refractory multiple myeloma. The trial was conducted in the United States and enrolled 43 participants.

Is REGN5459 the same as other drugs?

REGN5459 is a distinct investigational drug candidate developed by Regeneron Pharmaceuticals. It is not known by any other names, and it is not the same as other approved or investigational therapies for multiple myeloma.