DARZALEX FASPRO

(Daratumumab and Hyaluronidase-fihj)

ApprovedSmall molecule

Johnson & Johnson

DARZALEX FASPRO is one of 67 small molecule programs targeting Amyloid. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

AmyloidRecruiting

Plasma Cell MyelomaRecruiting

AL AmyloidosisRecruiting

Multiple MyelomaCompleted

DesensitizationEnrolling by invitation

AmyloidPhase 2

Recruiting

Plasma Cell MyelomaPhase 3

Recruiting

AL AmyloidosisPhase 3

Recruiting

Multiple MyelomaApproved

Completed

DesensitizationPhase 2

Enrolling by invitation

Competition

Competitive Landscape

282 competitors in Multiple Myeloma

#DrugCompanyPhaseTrials

Belamaf

GSK

Phase 3

39 2

TALVEY

Johnson & Johnson

Phase 3

24 3

DARZALEX FASPRO

Johnson & Johnson

Approved

5 4

Biaxin

AbbVie

Phase 3

15 5

Xpovio

KKaryopharm Therapeutics Inc

Phase 3

29 6

Vepesid

AAvyxa

Phase 3

17 7

Mozobil

GGenzyme, a Sanofi Company

Phase 3

15 8

BLENREP

GGlaxo Dba Glaxosmithkline

Phase 3

10 9

Mezigdomide

Bristol-Myers Squibb

Phase 3

11 10

Granulocyte Colony-Stimulating Factor

Sanofi

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 3Recruiting

Plasma Cell Myeloma

NCT04566328

Q4 2030

Phase 3Recruiting

AL Amyloidosis

NCT06022939

Q2 2031

Phase 3Recruiting

Multiple Myeloma

NCT05561387

Q4 2033

Phase 2Recruiting

Amyloid

NCT07110844

Clinical

Trials by Indication[1]

Multiple Myeloma5 trials

Home Based Daratumumab Administration for Patients With Multiple Myeloma

Completed·TThomas Jefferson University·Phase 4·NCT05511428·20 enrolled

A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM)

Terminated· Takeda logo

Takeda·Phase 1/2·NCT04776018·27 enrolled

Panobinostat in Combination With Daratumumab, Bortezomib and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma

Terminated·AAbdullah Khan·Phase 1·NCT04956302·1 enrolled

Show 2 more trials

Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment

Recruiting·SSWOG Cancer Research Network·Phase 3·NCT05561387·510 enrolled

ELDORADO: a Randomized Phase II Trial of Elranatamab or Daratumumab in Combination With Lenalidomide, Bortezomib, and Dexamethasone (RVd Lite) in Newly Diagnosed, Transplant Ineligible/Deferred Multiple Myeloma

Not yet recruiting·MMassachusetts General Hospital·Phase 2·NCT07247097·160 enrolled

Polyneuropathy1 trial

Daratumumab for Polyneuropathy Associated With MGUS

Withdrawn·GGeorgetown University·Phase 2·NCT06046287

AL amyloidosis1 trial

Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis

Recruiting·SSWOG Cancer Research Network·Phase 3·NCT06022939·338 enrolled

Daratumumab1 trial

Daratumumab in STK11 Mutated NSCLC

Completed·NNYU Langone Health·Phase 2·NCT05807048·8 enrolled

Desensitization1 trial

Daratumumab in HLA Desensitization Prior to Transplantation

Enrolling by invitation·—·Phase 2·NCT05300451·10 enrolled

2 more indications

Plasma Cell Myeloma1 trial

Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation

Recruiting·EECOG-ACRIN Cancer Research Group·Phase 3·NCT04566328·1,450 enrolled

Amyloid1 trial

A Phase 2 Clinical Trial of Teclistamab and Daratumumab in Previously Untreated AL Amyloidosis

Recruiting·RRajshekhar Chakraborty, MD·Phase 2·NCT07110844·25 enrolled

Regulatory

FDA Approval Timeline[4]

May 1, 2020

DARZALEX FASPRO

BLA BLA761145

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Daratumumab and Hyaluronidase-fihj. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Daratumumab and Hyaluronidase-fihj compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Daratumumab and Hyaluronidase-fihj. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761145). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Johnson & Johnson company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Johnson & Johnson

DARZALEX FASPRO

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q4 2030

Q2 2031

Q4 2033

Trials by Indication[1]

Multiple Myeloma5 trials

Polyneuropathy1 trial

AL amyloidosis1 trial

Daratumumab1 trial

Desensitization1 trial

Plasma Cell Myeloma1 trial

Amyloid1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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