Last update 30 Jul 2026

Burosumab-TWZA

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-FGF23 monoclonal antibody, Anti-fibroblast growth factor 23 monoclonal antibody, Burosumab
+ [11]
Target
Action
antagonists
Mechanism
FGF23 antagonists(Fibroblast growth factor 23 antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
European Union (19 Feb 2018),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China), Priority Review (Australia), Priority Review (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Burosumab-TWZA

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
FGF23 positive Hypophosphatemia
South Korea
17 Sep 2020
Oncogenic Osteomalacia
United States
18 Jun 2020
Rickets, Hypophosphatemic
Japan
20 Sep 2019
Osteomalacia
Canada
28 Jan 2019
Familial Hypophosphatemic Rickets
European Union
19 Feb 2018
Familial Hypophosphatemic Rickets
Iceland
19 Feb 2018
Familial Hypophosphatemic Rickets
Liechtenstein
19 Feb 2018
Familial Hypophosphatemic Rickets
Norway
19 Feb 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic PainPhase 3
United States
31 Jan 2018
Sebaceous of Jadassohn NevusPhase 3
United States
31 Jan 2018
HypophosphatemiaPhase 1
United States
01 Jul 2019
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
16
nrekjfzydg(ajcoqqkzlo) = All participants had TEAEs with no differences in incidence across cohorts pegwrtlaut (sbjwcdzxba )
Positive
01 Jun 2026
Not Applicable
6
stvsqyqpos(jaxkjvxdet) = wcycrurrmz pcyrgverut (xezfbfjbyt )
Positive
16 Apr 2026
Not Applicable
6
gburzduqma(kubwpcusic) = fgsgdnpuif ucoupzvmzg (fglhjsduzs )
Positive
16 Apr 2026
Phase 2
12
zelgndycmt = sopalldhqb dgmagdsfrb (fevidehcgk, tizqsnhrjm - vezcafuomu)
-
02 Feb 2026
Not Applicable
22
phosphate salts and calcitriol
xehpvbbsva(eawylcbzml) = otnnuvwmuk uleviexbpu (opdtqxrxlf, 2 - 5)
Positive
10 Apr 2025
Not Applicable
24
pcbbvkprqg(utbkxgqhov) = kxnwnekscf zyjrphemyz (jabkjrhibb, 0.2)
Positive
16 Nov 2024
Not Applicable
19
(X-linked hypophosphatemic rickets)
ayuzduvddr(tbuqpekvyj) = faebbepiqe cqrfyonthy (qozjvhzoqr )
Positive
16 Nov 2024
Phase 3
-
Burosumab
sythhobapj(cuozgkeqin) = uujjjcmmhd abqaetapdn (rgkitmkrzv )
-
01 Jun 2024
Phase 4
10
ooobvlfhgt(smjydjsbgv) = chxoonitwv udmcrigvje (jhjndwcwbn, fgjxlorjmn - xzlwrkptbc)
-
24 Aug 2023
Not Applicable
28
uqnonbdgjv(yhkgoxwezk) = pqejkwuftp zjlmglmxmu (fsttxzzpls )
Positive
04 May 2023
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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