Duvakitug Alternatives: How It Compares to Other TL1A Inhibitors

Hipa.ai Research · Source: ClinicalTrials.gov / AACT · Last updated: AI-augmented data · 2/7 curated

Duvakitug is a TL1A inhibitor, representing a class of biologics targeting the TL1A pathway. This comparison evaluates Duvakitug against other established therapies including Vedolizumab (Entyvio), Upadacitinib (Rinvoq), Mirikizumab (Omvoh), Adalimumab (Humira), and Ustekinumab (Stelara).

Expected Phase-3 readouts: TL1A alternatives for ulcerative colitis Bar = full Phase-3 ulcerative colitis program span (earliest start → latest expected readout). Dates are sponsor-estimated and routinely slip. 2005 2007 2009 2011 2013 2015 2017 2019 2021 2023 2025 2027 2029 2031 2033 Sponsor · Primary completion Adalimumab Humira • TBD • 10 trials Ustekinumab Stelara / PHOENIX 1 • Jul 2006 Vedolizumab Entyvio • Dec 2011 • 11 trials Upadacitinib Rinvoq • Jan 2021 • 4 trials Mirikizumab Omvoh • Jan 2021 • 8 trials P3 Afimkibart Hoffmann-La Roche • Jan 2027 • 3 trials P3 Duvakitug Sanofi • May 2028 • 2 trials today subject of this article first-to-read-out pivotal FDA approval (ulcerative colitis)

Source: ClinicalTrials.gov via AACT · Hipa.ai, 2026-05-07Download chart as PNG

The competitive landscape features established therapies such as Adalimumab (Humira), approved in 2002, and Ustekinumab (Stelara), approved in 2009. Duvakitug is currently in Phase 3 development, with another Phase 3 candidate, Afimkibart, also in the pipeline.

Quick comparison table

DrugClassApproved indicationsDosingYear approvedLead pivotal endpointAnnual cost (rough)
DuvakitugTL1A inhibitorSubcutaneousPipeline
Adalimumab (Humira)TNF-alpha inhibitorplaque psoriasis, psoriatic arthritis, rheumatoid arthritis, +5 more80 mg SC week 0, then 40 mg every other week from week 12012PASI 90: 41% @ week 16$78k
Vedolizumab (Entyvio)alpha-4 beta-7 integrin inhibitorulcerative colitis, Crohn's disease300 mg IV at weeks 0, 2, and 6, then 300 mg IV every 8 weeks; or 108 mg subcutaneously every 2 weeks for maintenance.201441.8% @ week 52$45k
Ustekinumab (Stelara)IL-12/23 inhibitor (p40)plaque psoriasis, psoriatic arthritis, Crohn's disease, +1 more45 mg or 90 mg SC at weeks 0 and 4, then every 12 weeks (weight-tiered)2019PASI 90: 42% @ week 12$70k
Upadacitinib (Rinvoq)JAK inhibitorRheumatoid arthritis, Psoriatic arthritis, Atopic dermatitis, +6 more45 mg once daily for 8 weeks, then 15 mg or 30 mg once daily202234% @ 8 weeks$73k
Mirikizumab (Omvoh)IL-23 inhibitorUlcerative colitis, Crohn's disease300 mg IV at weeks 0, 4, and 8, followed by 200 mg SC every 4 weeks starting at week 12202324.2% @ week 12$122k
AfimkibartTL1A inhibitorPipeline

Cost estimates are list-price approximations and do not reflect rebates, formulary tier, or out-of-pocket costs after benefits. The class-typical lead-pivotal endpoint here is Clinical remission; cells render each drug's actual pivotal endpoint, which may differ. The "Year approved" column shows the FDA approval year for ulcerative colitis specifically — drugs approved for other indications first appear with their this-indication date, or as Pipeline if not yet approved for this indication. Cross-trial comparisons can mislead — head-to-head Phase-3 data (when present) is below.

Duvakitug vs Vedolizumab (Entyvio)

No head-to-head Phase-3 trial directly compares Duvakitug with Vedolizumab.

Cross-trial caveat: the two drugs were tested in different patient populations at different time points. Cross-trial comparisons of response rates can mislead — the only rigorous comparison is a head-to-head randomized trial.

Duvakitug vs Upadacitinib (Rinvoq)

No head-to-head Phase-3 trial directly compares Duvakitug with Upadacitinib.

Cross-trial caveat: the two drugs were tested in different patient populations at different time points. Cross-trial comparisons of response rates can mislead — the only rigorous comparison is a head-to-head randomized trial.

Duvakitug vs Mirikizumab (Omvoh)

No head-to-head Phase-3 trial directly compares Duvakitug with Mirikizumab.

Cross-trial caveat: the two drugs were tested in different patient populations at different time points. Cross-trial comparisons of response rates can mislead — the only rigorous comparison is a head-to-head randomized trial.

Duvakitug vs Adalimumab (Humira)

No head-to-head Phase-3 trial directly compares Duvakitug with Adalimumab.

Cross-trial caveat: the two drugs were tested in different patient populations at different time points. Cross-trial comparisons of response rates can mislead — the only rigorous comparison is a head-to-head randomized trial.

Duvakitug vs Ustekinumab (Stelara)

No head-to-head Phase-3 trial directly compares Duvakitug with Ustekinumab.

Cross-trial caveat: the two drugs were tested in different patient populations at different time points. Cross-trial comparisons of response rates can mislead — the only rigorous comparison is a head-to-head randomized trial.

Pipeline alternatives

Investigational IL-17 / IL-17-related therapies in active Phase 3 development include Afimkibart from Hoffmann-La Roche. This agent is currently being evaluated in a lead Phase 3 trial, NCT06589986. Afimkibart represents a different mechanism of action compared to Duvakitug, functioning as an IL-17A nanobody, and its development appears to be approximately 1-2 years behind Duvakitug.

Choosing between Duvakitug and its alternatives

Duvakitug, as a TL1A inhibitor, offers a distinct mechanism of action compared to other available therapies for inflammatory conditions. This novel approach may be considered for patients who have not responded to or cannot tolerate other classes of biologics.

Established therapies like Vedolizumab (an alpha-4 beta-7 integrin inhibitor), Upadacitinib (a JAK inhibitor), Mirikizumab (an IL-23 inhibitor), Adalimumab (a TNF-alpha inhibitor), and Ustekinumab (an IL-12/23 inhibitor) have extensive real-world experience and well-characterized safety profiles. Vedolizumab achieved clinical remission in 41.8% of patients at week 52 with its maintenance dosing. Upadacitinib showed clinical remission in 34% of patients at 8 weeks. Mirikizumab demonstrated clinical remission in 24.2% of patients at week 12. Adalimumab achieved PASI 90 in 41% of patients at week 16, while Ustekinumab achieved PASI 90 in 42% of patients at week 12. These agents offer varied dosing schedules, from subcutaneous injections every two weeks (e.g., Vedolizumab maintenance) to every 12 weeks (Ustekinumab), and oral daily options (Upadacitinib), which may suit different patient preferences or clinical needs. The choice among these agents often considers specific patient characteristics, comorbidities, prior treatment history, and the desired speed of response.

Clinical decisions should always be made by a qualified healthcare professional, considering individual patient circumstances and the full prescribing information for each medication.

Sources and methodology

Trial data was pulled from the ClinicalTrials.gov registry via the AACT relational mirror maintained by the Clinical Trials Transformation Initiative. AACT data freshness: .

Cross-trial comparison limitations:drugs without a direct head-to-head trial are compared using each drug's own pivotal trial. These trials enrolled different patient populations at different time points and used different statistical analysis sets. Cross-trial response-rate differences should not be interpreted as proof that one drug is more effective than another.

Related drug pages on Hipa.ai

Not medical advice. This page summarizes publicly-reported clinical trial data for informational purposes. Treatment decisions belong with a qualified prescribing clinician who knows your medical history. Drug approvals, dosing, and safety profiles change over time — always confirm with the current FDA prescribing information.
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