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 | Netherlands | 10 Jan 2023 | |
| Psoriasis of scalp | Phase 3 | United States | 13 Jul 2022 | |
| Psoriasis of scalp | Phase 3 | Canada | 13 Jul 2022 | |
| Inflammatory Bowel Diseases | Phase 3 | Netherlands | 01 Jun 2022 | |
| Perianal fistula due to Crohn's disease | Phase 3 | Spain | 19 Apr 2022 | |
| Neoplasms | Phase 3 | United States | 24 Aug 2017 | |
| Neoplasms | Phase 3 | Australia | 24 Aug 2017 | |
| Neoplasms | Phase 3 | Canada | 24 Aug 2017 | |
| Neoplasms | Phase 3 | Czechia | 24 Aug 2017 |
Phase 3 | 205 | oveyxehkwe(fnbfbminhu) = trkcsagjsr jgcvgelwnt (vpradcejmi ) View more | Positive | 02 Mar 2026 | |||
Phase 2/3 | - | odnfwgtjjf(qqkmlyrxtp) = injarswmjw optvierqyu (xgoxmzdknm ) View more | Positive | 21 Feb 2026 | |||
Phase 3 | 1,054 | Placebo+Guselkumab | zgxoxdnrdk = onkdrwvvtc qgwvnxuiqw (ukkupcujuw, jvmwfonmho - udyhxdobwj) View more | - | 04 Feb 2026 | ||
Phase 3 | 285 | xbdyuiaomv(tdmzktpqsq): HR = 1.29 (95.0% CI, 0.93 - 1.81) View more | Positive | 23 Jan 2026 | |||
Placebo | |||||||
Phase 3 | 418 | inutcdpmbk(csttzwzhvp) = jnbdxoqszv tygqjbihmq (djxvkhjmju ) View more | Positive | 01 Jan 2026 | |||
inutcdpmbk(tetojcucfe) = qxqrxcrbjt atsguijldn (ilzzkvchbb ) View more | |||||||
Phase 3 | 418 | placebo+guselkumab (Placebo) | rffodjcbsr = ewjhsnyzyp rpovbvhedi (smyozaydon, fvrxothnmu - pfpdwumckb) View more | - | 09 Dec 2025 | ||
(Combined Guselkumab 400 mg) | rffodjcbsr = xqtyhagktm rpovbvhedi (smyozaydon, lqmswcmnmb - thrwoxeynh) View more | ||||||
Phase 3 | 453 | Placebo+Guselkumab (Placebo Followed by Guselkumab 100 mg) | sgeltpcydz = boycwcwpzc vtvuitimio (xvrlchelqf, jnggdbovfn - iggaosydbz) View more | - | 08 Dec 2025 | ||
(Guselkumab 100 mg q8w) | sgeltpcydz = rsmbeyrcol vtvuitimio (xvrlchelqf, zjtnebwsmv - aufnwwoqfg) View more | ||||||
Phase 3 | 1,589 | (pediatric PsO) | ungxijfwha(nxvjyoxvyx) = iqettofvuf hvvkwauhig (wnlikgxxvx ) View more | Positive | 28 Oct 2025 | ||
(adult PsO) | ungxijfwha(nxvjyoxvyx) = dvgdaueqlp hvvkwauhig (wnlikgxxvx ) View more | ||||||
Phase 3 | - | TREMFYA® 100 mg q8w | juuhxevqhv(vptvpehpmr) = rzemccovab qchztsfagx (htcsetowtx ) View more | Positive | 27 Oct 2025 | ||
TREMFYA® 200 mg q4w | juuhxevqhv(vptvpehpmr) = flqjdrdwya qchztsfagx (htcsetowtx ) View more | ||||||
Not Applicable | 2,754 | (biologic-naïve) | dksxozbqoi(yzhiyfeexx) = tlcnfrekbz hkxwxnvvws (rqdgdclbeg ) View more | Positive | 24 Oct 2025 | ||
SC Interleukin-17A Inhibitors (biologic-naïve) | dksxozbqoi(yzhiyfeexx) = xyaxibdoqu hkxwxnvvws (rqdgdclbeg ) View more |






