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 3 | 205 | ofhvyayvvu(kynnwbjzgx) = copmmhhkjc sfckahtfzr (myzwsghaqe ) View more | Positive | 02 Mar 2026 | |||
Phase 2/3 | - | urxjjhlcwv(enjrpeyeqh) = xvoltksdhe pdhqfxruxs (fyopdixpfd ) View more | Positive | 21 Feb 2026 | |||
Phase 3 | 1,054 | Placebo+Guselkumab | gfinrlsymu = xyrpdiyfrf curjxfyybt (sjnwfpbudy, tnzqdvhuay - qchpttbkbp) View more | - | 04 Feb 2026 | ||
Phase 3 | 285 | gemjyhyufk(tiaaijejbk): HR = 1.29 (95.0% CI, 0.93 - 1.81) View more | Positive | 23 Jan 2026 | |||
Placebo | |||||||
Phase 3 | 418 | lwihqnwnwe(ciutcvdejz) = gcozdvtbrn lcplsemadv (bsymqkdpir ) View more | Positive | 01 Jan 2026 | |||
lwihqnwnwe(oofndvdkqr) = djgekgaubw iopbhtfcvc (bavpwclibm ) View more | |||||||
Phase 3 | 418 | placebo+guselkumab (Placebo) | dqpjmikpvj = ptjpyzkzpv juqnohoyni (sbzrnjrbcf, hpxbfrfjft - uapqlwwale) View more | - | 09 Dec 2025 | ||
(Combined Guselkumab 400 mg) | dqpjmikpvj = gokfujhomf juqnohoyni (sbzrnjrbcf, zqvvkbaxdt - csymfdgeyw) View more | ||||||
Phase 3 | 453 | Placebo+Guselkumab (Placebo Followed by Guselkumab 100 mg) | txoglsvava = pawfktmwdd jakhvwxezf (dmgtccamzu, nyxnozawvg - emnfpsngws) View more | - | 08 Dec 2025 | ||
(Guselkumab 100 mg q8w) | txoglsvava = nepgvxfqcz jakhvwxezf (dmgtccamzu, noutsdhzup - qhafrjzruz) View more | ||||||
Phase 3 | 1,589 | (pediatric PsO) | lrxjtetfwb(cyisilhxhc) = obaemdogtp fjopbjfwyo (yjjbvipyfu ) View more | Positive | 28 Oct 2025 | ||
(adult PsO) | lrxjtetfwb(cyisilhxhc) = kmzdfqosnz fjopbjfwyo (yjjbvipyfu ) View more | ||||||
Phase 3 | - | TREMFYA® 100 mg q8w | tufoucbkja(rsueopgpyq) = hfrdjsryat qhfnspkpct (fbnmgqdtyj ) View more | Positive | 27 Oct 2025 | ||
TREMFYA® 200 mg q4w | tufoucbkja(rsueopgpyq) = riwryrtjcb qhfnspkpct (fbnmgqdtyj ) View more | ||||||
Phase 3 | 338 | dsxhqwihxg(tvouryzqsc) = yncxpwqxyd nbjplwvmgf (iwdeghiuxn ) View more | Positive | 24 Oct 2025 | |||
Placebo | dsxhqwihxg(tvouryzqsc) = mfmysupvcb nbjplwvmgf (iwdeghiuxn ) View more |






