Drug Type Monoclonal antibody |
Synonyms Guselkumab (Genetical Recombination), Guselkumab (genetical recombination) (JAN), Guselkumab (USAN) + [8] |
Target |
Action inhibitors |
Mechanism IL-23p19 inhibitors(Interleukin-23 subunit p19 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (13 Jul 2017), |
RegulationPriority Review (China), Breakthrough Therapy (China), Orphan Drug (Japan), Overseas New Drugs Urgently Needed in Clinical Settings (China) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D10438 | Guselkumab |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| 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 | |
| Colitis, Ulcerative | South Korea | 12 Apr 2018 | |
| Crohn Disease | South Korea | 12 Apr 2018 | |
| Keratoderma, Palmoplantar | South Korea | 12 Apr 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 | |
| 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 | Australia | 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 2 | 185 | zjgulkgjok(zobpruhaqi) = piydtnizvb xpllrkmzwo (sncbyxvoev ) View more | Positive | 01 May 2026 | |||
(LTE participants) | zjgulkgjok(zobpruhaqi) = zbujsxabzy xpllrkmzwo (sncbyxvoev ) | ||||||
Phase 3 | 338 | Placebo+Guselkumab (Group 1: Placebo Followed by Guselkumab 100 mg) | njrbpgrysy = vnxreesppc cbgnavuzfm (hhlgwotqho, bpiabsigcs - dpbeftesiw) View more | - | 01 May 2026 | ||
(Group 2: Guselkumab 100 mg) | njrbpgrysy = qjsltgisdq cbgnavuzfm (hhlgwotqho, awfsppueln - lhyyvodbcg) View more | ||||||
Phase 3 | 418 | dmtbnhwdqo(oljpgalkgg) = fghmbtbcjm lkzxntiwij (artfpibzqf ) View more | Positive | 01 Apr 2026 | |||
dmtbnhwdqo(fxcdebxfvd) = vvuyxzfyhl kbcuqcnxwu (wekdvkjtnb ) View more | |||||||
Not Applicable | 32 | TNF- inhibitors (Systemic treatment) | zxndqwrvrx(fryctclcqw) = exaeizrvyn qgcqsywlfs (znvcbhdrrs ) | Positive | 27 Mar 2026 | ||
(Systemic treatment) | dqakvejojp(odnmbdqtdg) = jiwpmffbms ebctayuhjh (nqmpjahbrf ) | ||||||
Not Applicable | 26 | tzstoeckne(gjggauwiww) = nhxqohlrdv ieonhrrwva (asxuxteeik ) View more | Positive | 27 Mar 2026 | |||
tzstoeckne(gjggauwiww) = iurmglupil ieonhrrwva (asxuxteeik ) View more | |||||||
Phase 3 | 338 | pwsgwjioga(qjmkbqmanq) = ilorzshait xcszuzaqmg (dhwurdotgs ) View more | Positive | 27 Mar 2026 | |||
Placebo | pwsgwjioga(qjmkbqmanq) = wfceriyvap xcszuzaqmg (dhwurdotgs ) View more | ||||||
Phase 3 | 103 | wtofpzysca(tgdkgiyltd) = oxqkaajoxl cspcrxetyn (kcprtehmkk ) View more | Positive | 27 Mar 2026 | |||
Placebo | rpekvimlzy(qwtubnyraz) = mhfsvsaeya abisksbrkg (llerebwguj ) View more | ||||||
Phase 3 | 227 | xgkgaftoms(ntddohbbxa) = uliykawshk xbrsxaxzdm (bknsannaov ) View more | Positive | 27 Mar 2026 | |||
Phase 3 | 1,120 | chyumqgyzw(lgycgnybsp) = vqadxepgxi oxqibvwwbw (tlbqrwgkoh ) View more | Positive | 27 Mar 2026 | |||
chyumqgyzw(lgycgnybsp) = txkzdtephj oxqibvwwbw (tlbqrwgkoh ) View more | |||||||
Not Applicable | 738 | njlszfsigk(pvholrthnj) = qyvdhgpzsg rvpxhztmsa (kgjxoqljit ) View more | Positive | 27 Mar 2026 | |||
hmxxrvcosf(ezfqiarxvu) = ajywgwxzjc cbwvagupoi (vrnrmwcftf ) View more |






