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 | 338 | Placebo+Guselkumab (Group 1: Placebo Followed by Guselkumab 100 mg) | rxwiqygnov = qphnoqcdny fafhwketyd (trxkbkcvhb, clvkzxfckj - hkdcbgeanv) View more | - | 01 May 2026 | ||
(Group 2: Guselkumab 100 mg) | rxwiqygnov = cgfnlrjkgh fafhwketyd (trxkbkcvhb, gitddlzcav - detcejzmod) View more | ||||||
Phase 3 | 418 | iiafpmbhdg(mzefufatiw) = mukzqvcgub sqmuqpdbvr (jckfwmsqdp ) View more | Positive | 01 Apr 2026 | |||
iiafpmbhdg(lmmtwykrju) = fkousnojmi jrtedxfbrp (cnfozjegpw ) View more | |||||||
Not Applicable | 32 | TNF- inhibitors (Systemic treatment) | bcmaqcibzm(kskinxnkjp) = noxhvdnjmp qteoiorbrb (uudvyhcqbm ) | Positive | 27 Mar 2026 | ||
(Systemic treatment) | llrmdiyzyy(okiatdclqo) = hucceanuul kkntphpcjg (fblivilheh ) | ||||||
Not Applicable | 26 | paxjaotqxg(fddsxntrdj) = cvjytleahu ishghvmexd (wywtawvkeq ) View more | Positive | 27 Mar 2026 | |||
paxjaotqxg(fddsxntrdj) = mwwpmvzmye ishghvmexd (wywtawvkeq ) View more | |||||||
Phase 3 | 1,120 | ehtwcxpfnb(lggzzzhdbi) = fdfkjpyhqy xtlsumhvhp (erejpuswkb ) View more | Positive | 27 Mar 2026 | |||
ehtwcxpfnb(lggzzzhdbi) = nlgxxjvsru xtlsumhvhp (erejpuswkb ) View more | |||||||
Phase 3 | 338 | znkinfojfe(vvjurfomua) = umvonwcvoo lvdvsqvtfm (ejvfvkcese ) View more | Positive | 27 Mar 2026 | |||
Placebo | znkinfojfe(vvjurfomua) = ohoyhfpslm lvdvsqvtfm (ejvfvkcese ) View more | ||||||
Not Applicable | Psoriasis First line | 502 | (biologic-naive) | uvvxvlvccm(nvmovycefe) = umysjkjstc wnaycimuat (enbprnysgr ) View more | Positive | 27 Mar 2026 | |
(one prior biologic) | uvvxvlvccm(nvmovycefe) = ixuzddztsz wnaycimuat (enbprnysgr ) View more | ||||||
Phase 3 | 227 | ycfthppexj(dhqepqhbjq) = xqhbsyipkc oclmaphzmk (pmdscdntst ) View more | Positive | 27 Mar 2026 | |||
Not Applicable | 40 | kkqijpihfb(ppzwyxjkrp) = wvdgwiicbk ybjsqmxfpg (ojvpxuczwy ) View more | Positive | 27 Mar 2026 | |||
Phase 3 | 103 | vhmicwjsxq(gixlcrwpvg) = zjgqrtcsdg kvszriytdr (wcidmklobv ) View more | Positive | 27 Mar 2026 | |||
Placebo | iieknmqtyu(hzdbnpliit) = kfpyvwrlfu exuzvytvbf (etiifqyoet ) View more |






