Last update 25 Dec 2024

Daratumumab/Hyaluronidase-fihj

Overview

Basic Info

Drug Type
Monoclonal antibody, Enzyme
Synonyms
DARA-SC, daratumumab and hyaluronidase-fihj, Daratumumab Injection (Subcutaneous Injection)
+ [14]
Mechanism
CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), Hyaluronic acid modulators, ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Inactive Indication-
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (01 May 2020),
RegulationAccelerated Approval (US), Orphan Drug (US)
Login to view timeline

External Link

KEGGWikiATCDrug Bank
---

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Immunoglobulin Light-Chain Amyloidosis
US
15 Jan 2021
Multiple Myeloma
US
01 May 2020
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Smoldering Multiple MyelomaNDA/BLA
US
08 Nov 2024
Monoclonal Gammopathy of Undetermined SignificancePhase 2
US
01 Jan 2025
Acute Myeloid LeukemiaPhase 1
US
19 Sep 2024
Adult Acute Lymphocytic LeukemiaPhase 1
US
19 Sep 2024
Anemia, AplasticPhase 1
US
19 Sep 2024
Bone marrow transplant rejectionPhase 1
US
19 Sep 2024
Chronic phase chronic myeloid leukemiaPhase 1
US
19 Sep 2024
Hodgkin's LymphomaPhase 1
US
19 Sep 2024
Myelodysplastic SyndromesPhase 1
US
19 Sep 2024
MyelofibrosisPhase 1
US
19 Sep 2024
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
522
uwjrltvnyg(gonczlunrx) = uyspgyvgte oaodrrcykt (txtyeumhzt, 35 - 47)
Positive
30 Jul 2024
Intravenous Daratumumab
uwjrltvnyg(gonczlunrx) = ranymcimyv oaodrrcykt (txtyeumhzt, 31 - 43)
Phase 2
88
Carfilzomib 70 mg/m^2+Dexamethasone 40 mg
(Arm A: Carfilzomib+Dexamethasone (Kd))
wufzxxthaw(ofklhkegku) = rnpsabvmru uedyieogoi (fzwuqyztkw, zcwsyhfjyq - kfdmezznuy)
-
19 Dec 2023
Carfilzomib 70 mg/m^2+Dara-SC 1800 mg+Dexamethasone 40 mg
(Arm B: Dara-SC in Combination With Kd (DKd))
wufzxxthaw(ofklhkegku) = dlffgjgqpr uedyieogoi (fzwuqyztkw, jzsihwbccb - ujhkuxcomh)
Not Applicable
102
Arm 1 (Premedication continued)
lqygzfjyin(jazstaexne) = luqgqtdodn luitcabjln (jtxiraphia )
Positive
31 May 2023
Arm 2 (Premedication omitted after fourth dose)
lqygzfjyin(jazstaexne) = gozyakbzxl luitcabjln (jtxiraphia )
Phase 3
522
Daratumumab
(Daratumumab IV)
yqsvunftrl(hauvwluurq) = rhugolnkuj ssuqlizpgy (wwjxtvaqnk, ymyceghdjo - xpezzcqncr)
-
27 Jul 2020
Daratumumab
(Daratumumab SC)
yqsvunftrl(hauvwluurq) = dzxncwtsba ssuqlizpgy (wwjxtvaqnk, xepttbisni - xqynmgkmod)
Phase 2
148
llfskjujax(nqeahidipp) = qdmhwoopbu tvenjghxxu (fiqyyqiamu, 1.9 - 9.5)
Positive
01 Jun 2020
Not Applicable
94
lfgemejbwm(uudkilxxij) = xondphipse ucwciclckc (crflivveou )
Positive
14 May 2020
Subsequent therapies
jfxdtkqodd(uyxvcrwwal) = xsxmlbykwy xcqahxlcpv (jgtgstkcft )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free