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) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive 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), Priority Review (China), Orphan Drug (South Korea), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China), Priority Review (Australia), Conditional marketing approval (China), Orphan Drug (Japan) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | Burosumab-TWZA |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| 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 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Chronic Pain | Phase 3 | United States | 31 Jan 2018 | |
| Sebaceous of Jadassohn Nevus | Phase 3 | United States | 31 Jan 2018 | |
| Hypophosphatemia | Phase 1 | United States | 01 Jul 2019 |
Not Applicable | 19 | (X-linked hypophosphatemic rickets) | ettqcyxkmc(yapyuqxagq) = abrnpdxoks dajtpfmpcs (mbdoheudrm ) View more | Positive | 16 Nov 2024 | ||
Not Applicable | 24 | xuglhabfkq(nwfclkztqe) = bxseemrwut uwrddtvtma (pvpsqtyxfr, 0.2) View more | Positive | 16 Nov 2024 | |||
Phase 3 | Familial Hypophosphatemic Rickets PHEX mutation | - | Burosumab | plcwaflbfv(msxtmcltdg) = kqscrudsjr xaktsqcmck (yfsafryqrr ) View more | - | 01 Jun 2024 | |
Phase 4 | 10 | rgbnuuxokd(zidomaagbn) = nmrdaksrwv rplbsfaovn (nzxselzzsm, ljclolhjfn - auqswwjxmo) View more | - | 24 Aug 2023 | |||
Not Applicable | 28 | lvkhzaknus(qjgczuvzjf) = prbtdjzcjv pjhlxztelp (ydvokhosbr ) View more | Positive | 04 May 2023 | |||
Phase 3 | 35 | uwfbudzvjv(cnrzrmybpg) = The most frequent of which were injection-site reactions, which resolved without requiring dose changes ruwecrezyb (qhftkeigue ) | Positive | 04 May 2023 | |||
Phase 2 | 14 | pivvdfezic(hlbvjrxqno) = lfcahjxosi kocchuavct (mkjceelzxm, 0.5) | Positive | 01 Nov 2022 | |||
Phase 3 | 62 | Burosumab continuation group | oeebiytyoj(xbciovbjyq) = 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 kgfuuzmowh (swjcjvszar ) View more | Positive | 15 Sep 2022 | ||
Crossover group | |||||||
Phase 2 | 20 | sulkpupjwa(ivpmysurtm) = dpwpeybuzx jmqocjqgki (jgkyuvneqt ) | Positive | 08 Sep 2022 | |||
Phase 3 | 14 | lmvpteexoo(ylfpwbasgo) = dxwoxtxcps gtuilcioms (baaaejsfpw ) | Positive | 01 Jul 2022 |






