Last update 26 Mar 2026

Guselkumab

Overview

Basic Info

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)
Originator Organization
Inactive 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)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D10438Guselkumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Juvenile Idiopathic ArthritisNDA/BLA
United States
02 Dec 2024
Pediatric Crohn's DiseasePhase 3
Netherlands
10 Jan 2023
Psoriasis of scalpPhase 3
United States
13 Jul 2022
Psoriasis of scalpPhase 3
Canada
13 Jul 2022
Inflammatory Bowel DiseasesPhase 3
Netherlands
01 Jun 2022
Perianal fistula due to Crohn's diseasePhase 3
Spain
19 Apr 2022
NeoplasmsPhase 3
United States
24 Aug 2017
NeoplasmsPhase 3
Australia
24 Aug 2017
NeoplasmsPhase 3
Canada
24 Aug 2017
NeoplasmsPhase 3
Czechia
24 Aug 2017
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
205
oveyxehkwe(fnbfbminhu) = trkcsagjsr jgcvgelwnt (vpradcejmi )
Positive
02 Mar 2026
Phase 2/3
-
odnfwgtjjf(qqkmlyrxtp) = injarswmjw optvierqyu (xgoxmzdknm )
Positive
21 Feb 2026
Phase 3
1,054
Placebo+Guselkumab
zgxoxdnrdk = onkdrwvvtc qgwvnxuiqw (ukkupcujuw, jvmwfonmho - udyhxdobwj)
-
04 Feb 2026
Phase 3
285
xbdyuiaomv(tdmzktpqsq): HR = 1.29 (95.0% CI, 0.93 - 1.81)
Positive
23 Jan 2026
Placebo
Phase 3
418
inutcdpmbk(csttzwzhvp) = jnbdxoqszv tygqjbihmq (djxvkhjmju )
Positive
01 Jan 2026
inutcdpmbk(tetojcucfe) = qxqrxcrbjt atsguijldn (ilzzkvchbb )
Phase 3
418
placebo+guselkumab
(Placebo)
rffodjcbsr = ewjhsnyzyp rpovbvhedi (smyozaydon, fvrxothnmu - pfpdwumckb)
-
09 Dec 2025
(Combined Guselkumab 400 mg)
rffodjcbsr = xqtyhagktm rpovbvhedi (smyozaydon, lqmswcmnmb - thrwoxeynh)
Phase 3
453
Placebo+Guselkumab
(Placebo Followed by Guselkumab 100 mg)
sgeltpcydz = boycwcwpzc vtvuitimio (xvrlchelqf, jnggdbovfn - iggaosydbz)
-
08 Dec 2025
(Guselkumab 100 mg q8w)
sgeltpcydz = rsmbeyrcol vtvuitimio (xvrlchelqf, zjtnebwsmv - aufnwwoqfg)
Phase 3
1,589
(pediatric PsO)
ungxijfwha(nxvjyoxvyx) = iqettofvuf hvvkwauhig (wnlikgxxvx )
Positive
28 Oct 2025
(adult PsO)
ungxijfwha(nxvjyoxvyx) = dvgdaueqlp hvvkwauhig (wnlikgxxvx )
Phase 3
-
TREMFYA® 100 mg q8w
juuhxevqhv(vptvpehpmr) = rzemccovab qchztsfagx (htcsetowtx )
Positive
27 Oct 2025
TREMFYA® 200 mg q4w
juuhxevqhv(vptvpehpmr) = flqjdrdwya qchztsfagx (htcsetowtx )
Not Applicable
2,754
(biologic-naïve)
dksxozbqoi(yzhiyfeexx) = tlcnfrekbz hkxwxnvvws (rqdgdclbeg )
Positive
24 Oct 2025
SC Interleukin-17A Inhibitors
(biologic-naïve)
dksxozbqoi(yzhiyfeexx) = xyaxibdoqu hkxwxnvvws (rqdgdclbeg )
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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