Last update 08 Nov 2024

Burosumab-TWZA

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-FGF23 monoclonal antibody, Anti-fibroblast growth factor 23 monoclonal antibody, Burosumab
+ [10]
Target
Mechanism
FGF23 antagonists(Fibroblast growth factor 23 antagonists)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (US), Orphan Drug (US), Conditional marketing approval (CN), Orphan Drug (KR), Orphan Drug (AU), Overseas New Drugs Urgently Needed in Clinical Settings (CN), Priority Review (AU), Priority Review (CN), Fast Track (US), Orphan Drug (EU)
Login to view timeline

External Link

KEGGWikiATCDrug Bank
-Burosumab-TWZA

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
FGF23 positive Hypophosphatemia
KR
17 Sep 2020
Oncogenic Osteomalacia
US
18 Jun 2020
Rickets, Hypophosphatemic
JP
20 Sep 2019
Osteomalacia
CA
28 Jan 2019
Familial Hypophosphatemic Rickets
EU
19 Feb 2018
Familial Hypophosphatemic Rickets
IS
19 Feb 2018
Familial Hypophosphatemic Rickets
LI
19 Feb 2018
Familial Hypophosphatemic Rickets
NO
19 Feb 2018
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic PainPhase 3
US
31 Jan 2018
Sebaceous of Jadassohn NevusPhase 3
US
31 Jan 2018
HypophosphatemiaPhase 1
US
01 Jul 2019
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
37
dnhgyliiix(jjputeczpj) = Four subjects of 37 (10.8 %) developed secondary HPTH with mean±SD PTH levels equal to 110±17.9 ng/l vgvfhyuzdk (cbstlhjotu )
Negative
21 Sep 2023
Not Applicable
Familial Hypophosphatemic Rickets
PHEX mutation | FGF-23
2
vtcmggrivn(oejchtenub) = aqedmeulju dhoylsbquj (redjbaforh )
Positive
21 Sep 2023
dkbzzpehzy(jaxhmrxevx) = ljaopvbdpn kiukcaxdnv (gawsuyeniw )
Phase 4
10
zvzpfaybwe(nllqmeifze) = phymcwmrsi ojahfsuckj (xtzhdlgfta, mrkmszdkin - aypulyutul)
-
24 Aug 2023
Not Applicable
-
(Viral infection)
shucnzqnzt(szfpesrymv) = rqhkcgcxqn rnxwaqdaza (hnlahfpjle )
-
08 Jun 2023
Not Applicable
-
Burosumab 60 mg q4 weeks
cgnabrszmx(afcpebdeiz) = Unfortunately, the patient was lost to follow up resulting in need for cessation of Burosumab therapy with return of her symptoms of fatigue, bone/joint pain, and severe hypophosphatemia of 1.3 mg/dL. She has now been restarted on Burosumab therapy. lqnwtdcliv (hwzywfjdxp )
-
05 Nov 2022
Not Applicable
Familial Hypophosphatemic Rickets
serum ALP levels | serum phosphate levels | renal tubular reabsorption of phosphate per glomerular filtration rate (TmP/GFR) ...
77
wbqhtidilu(mojisgdpah) = yyxeyrxrqs drkhqxyvvk (mltfwdjwpa )
Positive
15 Sep 2022
Not Applicable
15
ljkmgboern(oczpxzixuf) = reported in one patient utcagijiit (zoodaaczth )
-
15 Sep 2022
Conventional treatment (inorganic oral phosphate salts and calcitriol or alphacalcidol)
Phase 3
62
Burosumab continuation group
kcwqmntkua(uwezhpbkup) = The mean change from baseline exceeded the MID for Pain Interference at weeks 64 and 88 and for Fatigue at week 64 in the burosumab continuation group, and for Pain Interference and Fatigue at week 88 in the crossover group skwxcwbtyg (celydxfxqb )
Positive
15 Sep 2022
Crossover group
Phase 2
20
xjbkpqpcjw(xbbmcvvesa) = knuqarzdbb zrgmlheukw (udpphxfimf )
Positive
08 Sep 2022
Phase 3
14
fnwsbkgqlr(odopbhrxit) = xlvsfnymaj zphwkphwhe (gqmbsdstut )
Positive
01 Jul 2022
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