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Icotrokinra
Clinical data
Pronunciation/aɪkoʊtrəˈkɪnrə/
eye-koh-trə-KIN-rə
Trade namesIcotyde
Other namesJNJ-77242113, PN-21235, JNJ-2113, Icotrokinra hydrochloride (USAN US)
AHFS/Drugs.comMonograph
MedlinePlusa626053
License data
Routes of
administration		Oral
Drug classInterleukin 23 receptor antagonist
ATC code
  • None
Legal status
Legal status
Identifiers
  • (4S)-4-[[4-[[(2S)-2-[[(2S)-2-[[(4R,7S,10S,13S,16S,19R)-19-acetamido-7-(4-acetamidobutyl)-16-(2-amino-2-oxoethyl)-13-[(1R)-1-hydroxyethyl]-3,3,20,20-tetramethyl-10-[(7-methyl-1H-indol-3-yl)methyl]-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicosane-4-carbonyl]amino]-3-[4-(2-aminoethoxy)phenyl]propanoyl]amino]-3-naphthalen-2-ylpropanoyl]amino]oxane-4-carbonyl]amino]-5-[[(2S)-4-amino-1-[[(2S)-1-[(2-amino-2-oxoethyl)-methylamino]-1-oxo-3-pyridin-3-ylpropan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-5-oxopentanoic acid
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
Chemical and physical data
FormulaC90H120N20O22S2
Molar mass1898.19 g·mol−1
3D model (JSmol)
  • CC1=C2C(=CC=C1)C(=CN2)C[C@H]3C(=O)N[C@H](C(=O)N[C@@H](C(SSC([C@@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N3)[C@@H](C)O)CC(=O)N)NC(=O)C)(C)C)(C)C)C(=O)N[C@@H](CC4=CC=C(C=C4)OCCN)C(=O)N[C@@H](CC5=CC6=CC=CC=C6C=C5)C(=O)NC7(CCOCC7)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CC(=O)N)C(=O)N[C@@H](CC8=CN=CC=C8)C(=O)N(C)CC(=O)N)CCCCNC(=O)C
  • InChI=1S/C90H120N20O22S2/c1-48-16-14-20-59-57(46-97-72(48)59)42-64-79(122)99-60(21-12-13-34-96-50(3)112)77(120)108-75(89(7,8)134-133-88(5,6)74(98-51(4)113)84(127)104-66(44-69(93)115)81(124)107-73(49(2)111)83(126)102-64)85(128)103-62(39-52-23-26-58(27-24-52)132-37-32-91)78(121)100-63(40-53-22-25-55-18-10-11-19-56(55)38-53)82(125)109-90(30-35-131-36-31-90)87(130)106-61(28-29-71(117)118)76(119)101-65(43-68(92)114)80(123)105-67(41-54-17-15-33-95-45-54)86(129)110(9)47-70(94)116/h10-11,14-20,22-27,33,38,45-46,49,60-67,73-75,97,111H,12-13,21,28-32,34-37,39-44,47,91H2,1-9H3,(H2,92,114)(H2,93,115)(H2,94,116)(H,96,112)(H,98,113)(H,99,122)(H,100,121)(H,101,119)(H,102,126)(H,103,128)(H,104,127)(H,105,123)(H,106,130)(H,107,124)(H,108,120)(H,109,125)(H,117,118)/t49-,60+,61+,62+,63+,64+,65+,66+,67+,73+,74-,75-/m1/s1
  • Key:IVFNYXYPMJQSGF-QMRCQSNESA-N

Icotrokinra, sold under the brand name Icotyde, is a medication used for the treatment of plaque psoriasis.[1] It is a cyclic peptide that functions as a selective interleukin 23 (IL-23) receptor antagonist.[2] It is a synthetic peptide that binds selectively to the IL-23 receptor (IL-23R) with high affinity and competitively antagonizes the binding of IL-23.[3] It is an immunosuppressant and interleukin inhibitor.[3] It is being developed by Johnson & Johnson.[4]

Icotrokinra was approved for medical use in the United States in March 2026.[5][6]

Medical uses

[edit]

Icotrokinra is indicated for the treatment of moderate-to-severe plaque psoriasis in people aged twelve years of age and older who weigh at least 40 kilograms (88 lb) who are candidates for systemic therapy or phototherapy.[1]

Mechanism of action

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Icotrokinra is a targeted oral peptide that selectively binds to and blocks the interleukin 23 receptor (IL-23R), thereby inhibiting IL-23-mediated signaling.[2] The drug demonstrates high affinity for the human IL-23 receptor with a dissociation constant (KD) of 7.1 pM and inhibits IL-23-induced STAT3 phosphorylation in peripheral blood mononuclear cells with an IC50 of 5.6 pM.[7] The IL-23 pathway plays a central role in the inflammatory cascade underlying various autoimmune conditions, particularly those involving Th17 cells.[2]

Unlike injectable biologics that target IL-23 or its receptor, icotrokinra offers the convenience of oral administration while maintaining selective receptor binding.[8][9]

Safety and tolerability

[edit]

Across clinical studies, icotrokinra has demonstrated a favorable safety profile. In phase III trials for plaque psoriasis, the most common adverse events were upper respiratory tract infections and headache.[10] Pooled safety data from multiple studies showed similar rates of adverse events between icotrokinra and comparator groups.[11]

History

[edit]

Icotrokinra was jointly discovered by Johnson & Johnson (J&J) and Protagonist Therapeutics.[12][11]

The benefits of Icotyde are its ability to inhibit the IL-23/IL-23R-dependent release of proinflammatory cytokines leading to a decrease in disease severity and skin involvement, as shown in four phase 3 randomised, multi-centre, double-blind, placebo and/or active comparator-controlled studies involving nearly 2,500 adults and adolescents. The most common side effects are fungal infections.

Clinical trials

[edit]

Plaque psoriasis

[edit]

The clinical development program for plaque psoriasis includes several phase III studies:

ICONIC-LEAD
[edit]

The ICONIC-LEAD study is a phase III, randomized, double-blind, placebo-controlled trial evaluating icotrokinra versus placebo in patients with moderate to severe plaque psoriasis.[10]

The study met its co-primary endpoints, with 74% of patients achieving clear or almost clear skin (IGA 0/1) at week 24.[10][12]

ICONIC-ADVANCE 1 and 2
[edit]

The ICONIC-ADVANCE 1 and 2 studies are head-to-head phase III trials comparing icotrokinra to deucravacitinib (Sotyktu) in patients with moderate to severe plaque psoriasis.[11] Both studies met their co-primary endpoints and demonstrated superiority of icotrokinra over deucravacitinib.[11][13][14]

ICONIC-TOTAL
[edit]

The phase 3 ICONIC-TOTAL study showed once daily icotrokinra met the primary endpoint of IGA of 0/1 at week 16 compared to placebo.[15]

Ulcerative colitis

[edit]
ANTHEM-UC
[edit]

The ANTHEM-UC study is a phase IIb trial evaluating icotrokinra in adults with moderately to severely active ulcerative colitis.[16] The study met its primary endpoint of clinical response, with patients treated with the highest dose of icotrokinra achieving a response rate of 63.5% at week 12 versus 27% for placebo.[16]

Society and culture

[edit]
[edit]

Icotrokinra was approved for medical use in the United States in March 2026.[17]

In July 2026, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Icotyde, intended for the treatment of plaque psoriasis in adults and adolescents.[3] The applicant for this medicinal product is Janssen-Cilag International N.V.[3][18]

Names

[edit]

Icotrokinra is the international nonproprietary name.[19]

Icotrokinra is sold under the brand name Icotyde.[1]

References

[edit]
  1. 1 2 3 4 "Icotyde- icotrokinra tablet, film coated". DailyMed. 17 March 2026. Retrieved 24 March 2026.
  2. 1 2 3 Fourie AM, Cheng X, Chang L, Greving C, Li X, Knight B, et al. (July 2024). "JNJ-77242113, a highly potent, selective peptide targeting the IL-23 receptor, provides robust IL-23 pathway inhibition upon oral dosing in rats and humans". Scientific Reports. 14 (1) 17515. Bibcode:2024NatSR..1417515F. doi:10.1038/s41598-024-67371-5. PMC 11289455. PMID 39080319.
  3. 1 2 3 4 "Icotyde EPAR". European Medicines Agency (EMA). 24 July 2026. Retrieved 10 September 2026. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  4. ↑ "Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis" (Press release). Johnson & Johnson. 21 July 2025.
  5. ↑ "Drug Approval Package: Icotyde Tablet". U.S. Food and Drug Administration (FDA). 5 May 2026. Retrieved 10 September 2026.
  6. ↑ "FDA Approves Icotyde (icotrokinra) for the Treatment of Plaque Psoriasis". Drugs.com. 18 March 2026. Retrieved 19 March 2026.
  7. ↑ "Icotrokinra (JNJ-2113; JNJ-77242113; PN-235)". AbMole BioScience. Retrieved 19 September 2025.
  8. ↑ "Icotrokinra delivered an industry-leading combination of significant skin clearance with demonstrated tolerability in a once daily pill in Phase 3 topline results". JNJ (Press release). 18 November 2024. Archived from the original on 23 November 2024. Retrieved 25 November 2024.
  9. ↑ "Positive Phase 3 Results Announced for JNJ-2113 Treatment of Psoriasis". HCP Live. 19 November 2024. Retrieved 25 November 2024.
  10. 1 2 3 "Icotrokinra delivered an industry-leading combination of significant skin clearance with demonstrated tolerability in a once daily pill in Phase 3 topline results" (Press release). Johnson & Johnson. 18 July 2025.
  11. 1 2 3 4 Campbell P (19 September 2025). "ICONIC-ADVANCE: Icotrokinra Beats Deucravacitinib for Plaque Psoriasis". HCPLive. Retrieved 19 September 2025.
  12. 1 2 "A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis (ICONIC-LEAD)". clinicaltrials.gov. Archived from the original on 19 November 2024. Retrieved 25 November 2024.
  13. ↑ "A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis". clinicaltrials.gov. Archived from the original on 19 July 2024. Retrieved 25 November 2024.
  14. ↑ "A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)". clinicaltrials.gov. Archived from the original on 18 November 2024. Retrieved 25 November 2024.
  15. ↑ "A Study of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas (ICONIC-TOTAL)". clinicaltrials.gov. Archived from the original on 19 November 2024. Retrieved 25 November 2024.
  16. 1 2 "Icotrokinra meets primary endpoint of clinical response in ulcerative colitis study and shows potential to transform the treatment paradigm for patients" (Press release). Johnson & Johnson. 10 March 2025.
  17. ↑ "FDA approval of Icotyde (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide" (Press release). Johnson & Johnson. 18 March 2026. Retrieved 10 September 2026 – via PR Newswire.
  18. ↑ "First oral medicine targeting interleukin-23 receptor recommended for plaque psoriasis". European Medicines Agency (EMA). 24 July 2026. Retrieved 10 September 2026.
  19. ↑ World Health Organization (2024). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 92". WHO Drug Information. 38 (3). hdl:10665/379650.

Further reading

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