DARZALEX FASPRO

(Daratumumab and Hyaluronidase-fihj)

Phase 3Small molecule

Johnson & Johnson

DARZALEX FASPRO is one of 76 small molecule programs targeting AL amyloidosis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

AL AmyloidosisActive, not recruiting

Multiple MyelomaActive, not recruiting

AmyloidRecruiting

PolyneuropathyActive, not recruiting

AL AmyloidosisPhase 3

Active, not recruiting

Multiple MyelomaPhase 2

Active, not recruiting

AmyloidPhase 2

Recruiting

PolyneuropathyPhase 2

Active, not recruiting

Competition

Competitive Landscape

1135 competitors in Multiple Myeloma

#DrugCompanyPhaseTrials

DARZALEX FASPRO

Johnson & Johnson

Phase 3

6 2

Ninlaro

Takeda

Preclinical

18 3

Prolia

Amgen

Preclinical

5 4

Eliquis

Bristol-Myers Squibb

Preclinical

3 5

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Preclinical

2 6

Adriamycin

GGynecologic Oncology Group

Preclinical

9 7

Nolvadex

AstraZeneca

Preclinical

1 8

Oncovin

EEastern Cooperative Oncology Group

Preclinical

8 9

Intron a

Systemic Therapy

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

Timeline

Expected Milestones

Q4 2027

Phase 3Recruiting

Multiple 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 Myeloma6 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

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

Show 3 more trials

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

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

Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial

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

Daratumumab1 trial

Daratumumab in STK11 Mutated NSCLC

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

Desensitization1 trial

Daratumumab in HLA Desensitization Prior to Transplantation

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

1 more indication

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: Phase 3[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 Myeloma6 trials

Daratumumab1 trial

Polyneuropathy1 trial

AL amyloidosis1 trial

Desensitization1 trial

Amyloid1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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