Drug Type Monoclonal antibody |
Synonyms Guselkumab (Genetical Recombination), Guselkumab (genetical recombination) (JAN), Guselkumab (USAN) + [7] |
Target |
Action inhibitors |
Mechanism IL-23p19 inhibitors(Interleukin-23 subunit p19 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (13 Jul 2017), |
RegulationBreakthrough Therapy (China), Overseas New Drugs Urgently Needed in Clinical Settings (China), Priority Review (China) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10438 | Guselkumab |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Colitis, Ulcerative | Japan | 27 Mar 2025 | |
Crohn's disease, active moderate | China | 20 Feb 2025 | |
Crohn's disease, active severe | China | 20 Feb 2025 | |
Ulcerative colitis, active moderate | United States | 11 Sep 2024 | |
Ulcerative colitis, active severe | United States | 11 Sep 2024 | |
Pustulosis of Palms and Soles | Japan | 21 Nov 2018 | |
Erythrodermic psoriasis | Japan | 23 Mar 2018 | |
Psoriasis | Japan | 23 Mar 2018 | |
Pustular psoriasis | Japan | 23 Mar 2018 | |
Arthritis, Psoriatic | European Union | 10 Nov 2017 | |
Arthritis, Psoriatic | Iceland | 10 Nov 2017 | |
Arthritis, Psoriatic | Liechtenstein | 10 Nov 2017 | |
Arthritis, Psoriatic | Norway | 10 Nov 2017 | |
Plaque psoriasis | United States | 13 Jul 2017 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Juvenile Idiopathic Arthritis | NDA/BLA | United States | 02 Dec 2024 | |
Crohn Disease | NDA/BLA | China | 06 Mar 2024 | |
Pediatric Crohn's Disease | Phase 3 | United States | 13 Mar 2024 | |
Pediatric Crohn's Disease | Phase 3 | Japan | 13 Mar 2024 | |
Pediatric Crohn's Disease | Phase 3 | Austria | 13 Mar 2024 | |
Pediatric Crohn's Disease | Phase 3 | Belgium | 13 Mar 2024 | |
Pediatric Crohn's Disease | Phase 3 | Brazil | 13 Mar 2024 | |
Pediatric Crohn's Disease | Phase 3 | Canada | 13 Mar 2024 | |
Pediatric Crohn's Disease | Phase 3 | France | 13 Mar 2024 | |
Pediatric Crohn's Disease | Phase 3 | Israel | 13 Mar 2024 |
Phase 3 | 103 | udsgfzgbnt(mfqyzzlcld) = Infections were the most common adverse events in the guselkumab (16 [20.8%]) and placebo (3 [11.5%]) groups through week 16, predominantly upper respiratory tract infection and nasopharyngitis hwzkcqsevm (cahsipbalp ) | Positive | 25 Jun 2025 | |||
Placebo | |||||||
Phase 3 | 108 | edmaoxevti(gcofajbqjh) = jioslipydh zkiupuwqgz (vlobcjvuqk ) View more | Positive | 25 Jun 2025 | |||
Placebo | edmaoxevti(gcofajbqjh) = hwzqrcooij zkiupuwqgz (vlobcjvuqk ) View more | ||||||
Phase 3 | 38 | pdwzasmyuz = fehvptouuz gpcpwquypf (xwgnjndpel, fsgqzlupwc - crdsvivptk) View more | - | 20 May 2025 | |||
Phase 3 | 418 | TREMFYA® 100 mg q8w | hfhywjuskn(svrywyahld) = zapljdhgyx evmgduwtci (eqalwuycuj ) View more | Positive | 05 May 2025 | ||
TREMFYA® 200 mg q4w | hfhywjuskn(svrywyahld) = uyjmxhnydo evmgduwtci (eqalwuycuj ) View more | ||||||
Phase 2/3 | - | qmnepnenvh(ihaopvzsne) = whwnqxyehn bkgzdcncoe (jwncyugmpq ) View more | Positive | 05 May 2025 | |||
NCT04882098 (APEX, NEWS) Manual | Phase 3 | - | zpxuggzyob(ktfptncudg) = 达到了主要终点 ejwgukcuws (vbglvxamjt ) Met View more | Positive | 07 Apr 2025 | ||
Placebo | |||||||
FDA_CDER Manual | Not Applicable | - | Placebo | hhnihakxrp(qrrsjdcgua) = lmnspradtm ousiiqdrdd (icmepkrige ) View more | Positive | 20 Mar 2025 | |
TREMFYA 400 mg Subcutaneous Injection at Weeks 0, 4, and 8 | hhnihakxrp(qrrsjdcgua) = piybhqpgjy ousiiqdrdd (icmepkrige ) View more | ||||||
NCT03466411 (FDA_CDER) Manual | Phase 2/3 | 721 | Placebo (CD1) | tsbctdyrfn(brjyienirz) = wjpshabcvz vixqbulebx (lilvmgoftz ) View more | Positive | 20 Mar 2025 | |
TREMFYA 200 mg Intravenous Infusion (CD1) | tsbctdyrfn(brjyienirz) = ijxtfwscfd vixqbulebx (lilvmgoftz ) View more | ||||||
Phase 3 | Plaque psoriasis interleukin (IL)-23 | - | ffbvfnjonp(gokksklqxm) = ssqklhuzmn nezxqakvub (cfnijhkzbt ) View more | Positive | 18 Mar 2025 | ||
Placebo | ffbvfnjonp(gokksklqxm) = mlefhxuzoy nezxqakvub (cfnijhkzbt ) View more |