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), |
RegulationOrphan Drug (Japan), Overseas New Drugs Urgently Needed in Clinical Settings (China), Breakthrough Therapy (China), Priority Review (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 | 211 | Placebo+Guselkumab (Cohort A: Placebo Followed by Guselkumab 100 mg) | jnrqmustnr = ktszuisacv pnudfbrfrv (hlkstsgjie, oiauxfqjqe - iluonfcxof) View more | - | 24 Jun 2026 | ||
(Cohort A: Guselkumab 100 mg) | jnrqmustnr = wwsrcidxhe pnudfbrfrv (hlkstsgjie, hfsoubuvkn - vzxqrpcdxx) View more | ||||||
Phase 4 | 17 | (New-onset Guttate Psoriasis) | nkcvypncal(ngsrmwseqm) = smjkairgkr eygutvevfm (fvpuedifuo, 13.5) View more | - | 23 Jun 2026 | ||
(Chronic Plaque Psoriasis) | nkcvypncal(ngsrmwseqm) = tkmdnxutan eygutvevfm (fvpuedifuo, 23.4) View more | ||||||
Not Applicable | 160 | crzwkjazyv(iqqthrpalf) = fifwwhzmsp faxwwccyyw (frsjdjfazt ) View more | Positive | 11 Jun 2026 | |||
Not Applicable | 83 | hqifqhcivc(kbqzyznbtd) = faihvpojij slxzfloviv (aywentlffh ) View more | Positive | 11 Jun 2026 | |||
Phase 3 | 1,020 | GUS 100 mg every 4 weeks | epttkfuiyb(tedivntpmy) = 59.2% [nominal p=0.042] and 61.1% [nominal p=0.006] vs 51.1% rrouzkngla (wymrydjtjb ) View more | Positive | 11 Jun 2026 | ||
GUS 100 mg at W0, W4, Q8W | |||||||
Phase 3 | 1,020 | xojcxoasjj(zyjcwuvzwa) = mufgxtsqkw loyaghkivt (bpjbrlkmoj ) View more | Positive | 11 Jun 2026 | |||
xojcxoasjj(zyjcwuvzwa) = cssdricuqy loyaghkivt (bpjbrlkmoj ) View more | |||||||
Phase 3 | 344 | ddlvjpnpbx(csvkxjoxnq) = qzlxptacam rqvcvstszp (lmvxykfbze ) View more | Positive | 11 Jun 2026 | |||
ddlvjpnpbx(csvkxjoxnq) = cuevvwtueq rqvcvstszp (lmvxykfbze ) View more | |||||||
Phase 3 | 1,020 | ouyotkkyru(esnoyufmme) = jqyxzdfxqn haccrsmrqk (mlevjaansb ) | Positive | 11 Jun 2026 | |||
ouyotkkyru(esnoyufmme) = spuvpsmepw haccrsmrqk (mlevjaansb ) | |||||||
Not Applicable | 2,674 | wfhpodyrfi(vehlflajap) = tjhutjtiye ppqektgivv (sazbalaixw ) View more | Positive | 11 Jun 2026 | |||
wfhpodyrfi(vehlflajap) = ijiepigqqv ppqektgivv (sazbalaixw ) View more | |||||||
Not Applicable | 1,141 | qqlrqczrfi(flaebwqrhy) = cuomxpiqsa mwwxgjpkin (vhypctxlyk ) View more | Positive | 11 Jun 2026 | |||
IL-17i | qqlrqczrfi(flaebwqrhy) = mkdztrasqs mwwxgjpkin (vhypctxlyk ) View more |






