The Hidradenitis Suppurativa Therapeutic Pipeline

Key Takeaways

• Despite three FDA-approved biologics, patient dissatisfaction and delayed diagnosis highlight the need for additional effective therapies for hidradenitis suppurativa (HS).
• The therapeutic pipeline for HS is robust, with JAK inhibitors (eg, upadacitinib, povorcitinib, topical ruxolitinib) showing clinically meaningful HiSCR responses in phase II and III trials, supporting JAK-STAT pathway inhibition as a promising strategy.
• Emerging biologics targeting IL-17, IL-1, BTK, and IL-36 pathways—including sonelokimab, lutikizumab, remibrutinib, and spesolimab—have shown encouraging efficacy signals with acceptable safety profiles in mid- to late-phase trials.
• Multiple phase III and long-term extension studies are ongoing across diverse mechanisms of action, reflecting a shift toward mechanism-driven, targeted therapies aimed at improving disease control and long-term outcomes in moderate-to-severe HS.

Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disorder characterized by painful nodules, abscesses, draining tunnels, and scarring that typically occur in intertriginous regions of the body. The prevalence of HS globally is around 1% with variation across geographic regions, and the onset of disease typically occurs in adolescence or early adulthood.¹ The symptoms of HS include itch, pain, and drainage, and patients have a higher frequency of comorbid mood disorders, resulting in a negative impact on patient quality of life.²

Currently, there are three US Food and Drug Administration (FDA)-approved therapies for HS. All are monoclonal antibodies targeting various cytokines involved in inflammation or immune cell activation. Adalimumab is a tumor necrosis factor (TNF) α inhibitor, secukinumab is an IL-17A inhibitor, and bimekizumab is an IL-17A/F inhibitor.^3–5 Trials involving these medications determined individual efficacy in reducing disease severity as well as excellent safety profiles.^3–5 Of note, evidence points to a “window of opportunity” for adalimumab therapy, in which worse clinical outcomes are associated with delayed initiation of therapy after symptom onset.⁶ This window underscores the importance of prompt diagnosis and introduction of treatment to improve outcomes for patients. Unfortunately, patients express dissatisfaction with current treatments.² These factors highlight the need for additional safe and effective therapies to treat HS. Though treatment options are currently limited, the pipeline for HS therapeutics is active with numerous medications in development. 

JAK Inhibitors

The Janus kinase (JAK) family of proteins is comprised of JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2), all of which modulate the transcription of inflammatory genes. Notable medications in this class with ongoing phase III clinical trials include upadacitinib, povorcitinib, and topical ruxolitinib.

Upadacitinib is an oral, selective JAK1 inhibitor currently FDA-approved for the treatment of rheumatoid arthritis and moderate-to-severe atopic dermatitis in adults and adolescents ages 12 and older.⁷ In a phase II trial of upadacitinib 30 mg in 68 participants with moderate-to-severe HS, significantly more participants achieved Hidradenitis Suppurativa Clinical Response (HiSCR) 50, defined as a ≥50% reduction in abscesses and inflammatory nodules without an increase in the number of abscesses or draining tunnels, by 12 weeks of treatment when compared to placebo controls with an adjusted difference of 14.7% (nominal P = 0.087).⁸ The participants who initially received placebo and then upadacitinib 15 mg had a 52.6% HiSCR 50 rate after 12 weeks on active medication. Most commonly reported adverse events with upadacitinib during the double-blind period included headache, dizziness, acne, and urinary tract infections. A phase III trial (Step-UP HS) with estimated enrollment of 1,328 participants who have failed prior anti-TNF therapy is anticipated to conclude in March 2028 and will assess HiSCR 50 rates at week 16.⁹

Povorcitinib is another oral, small molecule JAK1 inhibitor. It currently does not have any active indications from the FDA. In a phase II clinical trial including 209 participants, a 15-mg dose demonstrated a significantly higher HiSCR 50 rate compared to placebo (48.8% vs 28.8%) at 16 weeks of treatment.¹⁰ A pair of phase III trials, STOP-HS1 and STOP-HS2, demonstrated similar results, with participants on 45-mg and 75-mg doses achieving significantly higher HiSCR 50 rates by 12 weeks when compared to placebo controls.¹¹ The percentage of participants achieving HiSCR 50 by 12 weeks of treatment on active doses ranged from 40.2% to 42.3% while placebo rates ranged from 28.6% to 29.7%.¹¹ There are also long-term extension and long-term rollover trials (STOP-HS-LTE and STOP-HS-LTR) estimated to be completed in December 2026 and February 2028, respectively.^12,13 Additionally, an upcoming phase II trial evaluating the safety and efficacy of oral povorcitinib in adolescents with moderate-to-severe HS is anticipated to enroll 40 participants and conclude by March 2028.¹⁴

Topical ruxolitinib is a selective JAK1/2 inhibitor currently FDA approved for mild-to-moderate atopic dermatitis and nonsegmental vitiligo in adults and children ages 2 and older. In a phase II trial of ruxolitinib 1.5% cream for mild-to-moderate HS in 69 participants, 79.2% of patients applying ruxolitinib twice daily achieved HiSCR 50 at 16 weeks compared to 50.0% of patients using placebo. The trial was continued with all patients using ruxolitinib on an as-needed basis through 32 weeks. Similar percentages of patients from both original groups achieved HiSCR 50 (88.5% of patients who swapped to ruxolitinib compared to 81.0% of patients who maintained ruxolitinib treatment).¹⁵ The most commonly reported adverse events with topical ruxolitinib during the double-blind vehicle-controlled period were nasopharyngitis and COVID-19. An additional phase II trial will enroll 24 participants to evaluate the HiSCR 50 rate after twice-daily application of ruxolitinib 1.5% cream for 16 weeks.¹⁶ A pair of phase III clinical trials (known as TRuE-HS1 and TRuE-HS2) expects to enroll a total of 850 participants through July 2027.¹⁷

IL-17 Inhibitors

IL-17 is an interleukin cell signaling molecule secreted by a variety of structural and immune cells in the skin to maintain barrier integrity and mount a response to extracellular pathogens.¹⁸ IL-17 is an intriguing target for HS as studies have shown that the local skin environment of patients with HS have significantly higher IL-17 gene expression than healthy controls.¹⁹ Beyond the IL-17 inhibitors already FDA approved for HS, two additional medications targeting this pathway are currently in the pipeline: sonelokimab and tibulizumab.

Sonelokimab is a trivalent nanobody that binds IL-17A, IL-17F, and serum albumin with humanized sequences to reduce immunogenicity.²⁰ A phase IIb study of sonelokimab in 234 patients with moderate-to-severe HS demonstrated that 43.3% of patients receiving 120 mg and 34.8% of patients receiving 240 mg of sonelokimab achieved HiSCR 75 (a ≥75% reduction in abscesses and inflammatory nodules without an increase in the number of abscesses or draining tunnels) at week 12 when compared to 14.7% of patients on placebo.²¹ By 24 weeks of treatment, 57% of patients receiving 120 mg of sonelokimab achieved HiSCR 75 and 38% of patients receiving 120 mg of sonelokimab achieved HiSCR 90, and no new safety concerns for IL-17 inhibitors were identified.²² A pair of phase III trials (VELA-1 and VELA-2) enrolled 838 participants to evaluate HiSCR 75 response rates at week 16. Response rates for sonelokimab 120 mg were consistent between the two trials, with 34.8% and 35.9% of patients in VELA-1 and VELA-2, respectively, achieving HiSCR75 at week 16, though VELA-2 just missed statistical significance based on the pre-specific composite analysis strategy, potentially impacted by a higher placebo response rate.²³ There is also an open-label extension trial (VELA-OLE) estimated to be completed in June 2028.²⁴ One currently enrolling phase III trial (VELA-TEEN) will assess the pharmacokinetics and safety of subcutaneous sonelokimab in adolescents ages 12 to 17 with moderate-to-severe HS with anticipated enrollment of 35 patients and expected study conclusion by March 2027.²⁵

Tibulizumab is a bispecific, dual antagonist monoclonal antibody that targets both human B cell activating factor (BAFF) and IL-17A.²⁶ A phase II clinical trial on tibulizumab, TibuSHIELD, is currently recruiting adults with moderate-to-severe HS across the United States, Canada, and Europe with results expected to be reported in the third quarter of 2026.

IL-1 Inhibitors

IL-1, a proinflammatory chemokine mediating the acute phase of inflammation, is an alternative target for HS with multiple therapeutics currently in development. Lutikizumab is a dual anti-1α/β inhibitor that inhibits both targets without impacting the remainder of the extensive IL-1 pathway.²⁹ A phase II trial of subcutaneous lutikizumab of 210 patients with moderate-to-severe HS who have failed anti-TNF therapy is expected to be completed in early 2026.³⁰ Preliminary data from phase II trials of 153 patients show that only patients receiving subcutaneous lutikizumab 300 mg every other week and not every week achieved a significantly higher proportion of HiSCR 50 by 16 weeks of treatment when compared to placebo (59.5% of 300 mg every other week vs 48.7% of 300 mg every week vs 35.0% of placebo).³¹ Adverse events included HS flare, diarrhea, headache, pruritus, contact dermatitis, eczema, and nasopharyngitis. An additional phase II trial including 60 participants opened in August 2024 and is estimated to be completed in February 2027.³² Finally, a phase III, multi-center, randomized, double-blind, placebo-controlled trial of subcutaneous lutikizumab in adults and adolescents with moderate-to-severe HS will enroll an anticipated 1280 patients to assess HiSCR 75 rate at week 16 with expected study completion by December 2026.³³

LAD191, a monoclonal antibody targeting IL-1 receptor accessory protein (IL-1RAP), is a unique therapeutic option that targets a receptor-associated protein as opposed to the chemokine or the receptor itself. LAD191 was studied in a phase I trial comprising 40 participants, with injection site reaction being the only treatment-emergent adverse event (TEAE) reported by >2 participants.³⁴ Additionally, a phase II trial for adults with moderate-to-severe HS will enroll an estimated 200 participants to assess HiSCR 50 rates at week 16 for three dosing regimens of LAD191 compared to adalimumab and placebo before projected study completion in May 2027.³⁵

The final IL-1 pathway-related therapeutic option in the HS pipeline is LT-002-158, an IL-1 receptor-associated kinase 4 (IRAK4) degrader. IRAK4 is a molecular target for HS that exists downstream of IL-1 receptor activation and an IRAK4 degrader seeks to prevent the release of inflammatory molecules such as TNFα, IL-6, and IL-17 from a variety of immune cells.³⁶ A phase I/II clinical trial for oral LT-002-158 in adult patients with moderate-to-severe HS is not yet recruiting.³⁷

Bruton’s Tyrosine Kinase (BTK) Inhibitor

Analysis of the immune cells infiltrating tunnels from patients with HS demonstrated an enrichment of B cells and resultant increased Bruton’s tyrosine kinase (BTK) signaling.³⁸ BTK is crucial for B cell proliferation and development, making BTK inhibitors an interesting possible target for HS.³⁹

Remibrutinib is a highly selective oral small molecule BTK inhibitor that is currently FDA approved for treatment of chronic spontaneous urticaria. A phase IIb trial of 66 patients with moderate-to-severe HS demonstrated 73% HiSCR 50 achievement for patients receiving twice-daily 25 mg remibrutinib and 49% HiSCR 50 achievement for patients receiving 100 mg remibrutinib compared to 34.7% of patients receiving placebo at 16 weeks.⁴⁰ Additionally, fewer patients receiving active medication reported a very or extremely large impact of HS on their dermatology life quality index (DLQI, 11-30) when compared to patients on placebo (30.3% on 25 mg remibrutinib vs 24.2% on 100 mg remibrutinib vs 36.7% on placebo).⁴¹ A pair of phase III trials (RECHARGE 1 and 2) will study HiSCR 50 rates at week 16 for two doses of remibrutinib in an anticipated 555 patients and is expected to be completed by October 2028.^42,43

IL-36 Inhibitors

IL-36 has been implicated in the inflammatory process of HS as IL-36 cytokines have been demonstrated to be elevated in draining tunnels.⁴⁴ There are two IL-36 inhibitors currently being studied for HS treatment: spesolimab and HB0043.

A phase II trial that enrolled 52 patients with moderate-to-severe HS demonstrated lower International Hidradenitis Suppurativa Severity Score System (IHS4) scores as well as reductions in number and severity of draining tunnels in patients receiving spesolimab.⁴⁴ Common adverse events included headache, nasopharyngitis, nausea, fatigue, injection site pain and erythema. A phase III trial (Lunsayil 1) was completed in March 2025 with 209 enrolled patients, but results are not yet available.⁴⁵ The primary endpoint was the percent change from baseline in draining fistula/tunnel count at week 8. A long-term extension trial (Lunsayil LTE) was completed in April 2025 to assess adverse events in 39 participants.⁴⁶

HB0043 is a bispecific anti-IL-17/IL-36 antibody, targeting two key inflammatory cytokines associated with HS severity and disease progression.⁴⁷ Preliminary studies for HB0043 in animals demonstrates increased anti-inflammatory potency as well as excellent safety profile with reduced skin inflammation in multiple models as well as no enhanced target-related toxicity when compared to the individual monoclonal antibodies.⁴⁷ A phase I/II clinical trial for three doses of HB0043 in 15 adult patients with moderate-to-severe HS is currently recruiting participants with results expected in early 2026.⁴⁸

Other Medications

​CIT-013, an anti-citrullinated histone antibody, specifically targets citrullinated histones to impair neutrophil-mediated release of neutrophil extracellular traps, which contribute to the pathology of HS and other autoimmune disorders.⁴⁹ Currently, a phase II study (Citylights trial) of two doses of CIT-013 compared to placebo for adult patients with HS is recruiting an anticipated 96 patients with expected study conclusion in July 2027.⁵⁰ The trial endpoint will be HiSCR 75 rates at week 12.

​Tulisokibart is a humanized monoclonal antibody targeting both soluble and membrane-bound TNF-like cytokine 1A, which targets a key cytokine associated with tissue inflammation as well as fibrosis.⁵¹ A phase II randomized, double-blind, placebo-controlled study for adult patients with moderate-to-severe HS (MK-7240-012) will soon be recruiting an expected 147 patients to assess HiSCR50 rates at week 16, with anticipated study end date in January 2029.⁵²

​Anifrolumab is a humanized antibody that targets the interferon receptor subunit 1 (IFNAR1) to reduce the cellular response to type I interferons, which is contributes to tissue damage and impaired or dysregulated immune responses in multiple autoimmune diseases.⁵³ Anifrolumab is currently FDA-approved to treat moderate to severe systemic lupus erythematosus. A prospective, open-label study to determine the safety and efficacy of intravenous anifrolumab for HS will recruit an expected 15 patients with anticipated study completion by May 2026.⁵⁴

​There are numerous medications currently in the clinical trials pipeline for the treatment of HS; this is not an exhaustive list of medications in development. It is an exciting time to be treating patients with HS as the continued inquiry into new modalities of therapeutics gives hope that we may be able to improve patients’ quality of life and reduce their disease burdens. 

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12. Incyte Corporation. A phase 3, double-blind study to evaluate the long-term safety and efficacy of povorcitinib in participants with moderate to severe hidradenitis suppurativa. ClinicalTrials.gov. Published 2025. Accessed December 10, 2025. https://clinicaltrials.gov/study/NCT06212999

13. Incyte Corporation. A phase 3b, multicenter, rollover study for participants previously enrolled in clinical trials of povorcitinib. ClinicalTrials.gov. Published 2025. Accessed December 31, 2025. https://clinicaltrials.gov/study/NCT06855498

14. Incyte Corporation. A phase 2, open-label study to evaluate the safety, pharmacokinetics, and efficacy of povorcitinib in adolescents with moderate to severe hidradenitis suppurativa. ClinicalTrials.gov. Published 2025. Accessed December 18, 2025. https://clinicaltrials.gov/study/NCT07213973

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17. Incyte Corporation. A phase 3, double-blind, randomized, vehicle-controlled, efficacy and safety study of ruxolitinib cream in participants with hidradenitis suppurativa. ClinicalTrials.gov. Published 2025. Accessed December 18, 2025. https://clinicaltrials.gov/study/NCT06959225

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24. MoonLake Immunotherapeutics AG. A phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with moderate to severe hidradenitis suppurativa. ClinicalTrials.gov. Published 2025. Accessed December 31, 2025. https://clinicaltrials.gov/study/NCT07007637

25. MoonLake Immunotherapeutics AG. An open-label, single-arm study to evaluate the pharmacokinetics and safety of subcutaneous sonelokimab in adolescents aged ≥12 to ≤17 years at the time of study inclusion with active moderate to severe hidradenitis suppurativa. ClinicalTrials.gov. Published 2025. Accessed December 18, 2025. https://clinicaltrials.gov/study/NCT06768671

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30. AbbVie. A phase 2 multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of lutikizumab (ABT-981) in adult subjects with moderate to severe hidradenitis suppurativa who have failed anti-TNF therapy: amended protocol to include a lutikizumab open-label sub-study in subjects naïve to biologic therapy. ClinicalTrials.gov. Published 2025. Accessed November 26, 2025. https://clinicaltrials.gov/study/NCT05139602

31. AbbVie. Lutikizumab showed positive results in a phase 2 trial of adults with moderate to severe hidradenitis suppurativa as program advances to phase 3. Accessed January 15, 2026. https://www.prnewswire.com/news-releases/lutikizumab-showed-positive-results-in-a-phase-2-trial-of-adults-with-moderate-to-severe-hidradenitis-suppurativa-as-program-advances-to-phase-3-302027605.html

32. AbbVie. A multicenter open-label interventional biomarker study of lutikizumab in adult subjects with moderate-to-severe hidradenitis suppurativa or adult subjects with moderate-to-severe atopic dermatitis. ClinicalTrials.gov. Published 2025. Accessed December 31, 2025. https://clinicaltrials.gov/study/NCT06524635

33. AbbVie. A phase 3 multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of lutikizumab in adult and adolescent subjects with moderate to severe hidradenitis suppurativa. ClinicalTrials.gov. Published 2025. Accessed December 10, 2025. https://clinicaltrials.gov/study/NCT06468228

34. Farag A, Mir JA, Vitry F, Malvisi L, Gil EG. 63386 phase I single and multiple ascending-dose study to assess the safety, tolerability, and pharmacokinetics of LAD191, a monoclonal antibody against the interleukin-1 receptor accessory protein (IL-1RAP), in healthy volunteers. J Am Acad Dermatol. 2025;93(3):AB269. https://doi.org/10.1016/j.jaad.2025.05.1068

35. Almirall SA. A seamless phase 2a/2b, randomized, double-blind, placebo- and active-controlled, multiple-arm, multiple-stage, adaptive study evaluating the efficacy and safety of LAD191 in adults with moderate-to-severe hidradenitis suppurativa. ClinicalTrials.gov. Published 2025. Accessed November 26, 2025. https://clinicaltrials.gov/study/NCT07151937

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37. Leadingtac Pharmaceutical (Shaoxing) Co Ltd. A phase Ic/II clinical study to explore the safety, tolerability, efficacy, and pharmacokinetics of multiple oral doses of LT-002-158 tablets in Chinese adult patients with hidradenitis suppurativa. ClinicalTrials.gov. Published 2025. Accessed November 26, 2025. https://clinicaltrials.gov/study/NCT06932003

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40. Manalac T. Novartis’ remibrutinib shows promise in small mid-stage hidradenitis suppurativa study. BioSpace. Published March 11, 2024. Accessed January 15, 2026. https://www.biospace.com/novartis-remibrutinib-shows-promise-in-small-mid-stage-hidradenitis-suppurativa-study

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42. Novartis Pharmaceuticals. A randomized, double-blind, double-dummy, placebo-controlled, multicenter, phase 3 study assessing the efficacy, safety, and tolerability of 2 doses of remibrutinib over a 68-week treatment period in adult patients with moderate to severe hidradenitis suppurativa. ClinicalTrials.gov. Published 2025. Accessed December 31, 2025. https://clinicaltrials.gov/study/NCT06799000

43. Novartis Pharmaceuticals. A randomized, double-blind, double-dummy, placebo-controlled, multicenter, phase 3 study assessing the efficacy, safety, and tolerability of 2 doses of remibrutinib over a 68-week treatment period in adult patients with moderate to severe hidradenitis suppurativa. ClinicalTrials.gov. Published 2025. Accessed December 31, 2025. https://clinicaltrials.gov/study/NCT06840392

44. Alavi A, Prens EP, Kimball AB, et al. Proof-of-concept study exploring the effect of spesolimab in patients with moderate-to-severe hidradenitis suppurativa: a randomized, double-blind, placebo-controlled clinical trial. Br J Dermatol. 2024;191(4):508-518. https://doi.org/10.1093/bjd/ljae144

45. Boehringer Ingelheim. Randomized, double-blind, placebo-controlled, phase IIb/phase III study to evaluate the efficacy and safety of spesolimab in patients with moderate to severe hidradenitis suppurativa (Lunsayil 1). ClinicalTrials.gov. Published 2025. Accessed December 10, 2025. https://clinicaltrials.gov/study/NCT05819398

46. Boehringer Ingelheim. Lunsayil LTE: an extension trial assessing long-term spesolimab treatment in patients with hidradenitis suppurativa (HS). ClinicalTrials.gov. Published 2025. Accessed December 31, 2025. https://clinicaltrials.gov/study/NCT06241573

47. Ma X, Zhang S, Ren X, et al. Dual blockade of IL-17A and IL-36 pathways via a bispecific antibody exhibits enhanced anti-inflammatory potency. Front Immunol. 2024;15:1434127. https://doi.org/10.3389/fimmu.2024.1434127

48. Shanghai Huaota Biopharmaceutical Co Ltd. A phase I/II, open-label, dose-escalation clinical trial to evaluate the safety and efficacy of HB0043 (bispecific antibody targeting IL-17A and IL-36R) in adult patients with moderate to severe hidradenitis suppurativa (HS). ClinicalTrials.gov. Published 2025. Accessed November 30, 2025. https://clinicaltrials.gov/study/NCT06895499

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52. Merck Sharp & Dohme LLC. A phase 2b, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of tulisokibart in participants with moderate to severe hidradenitis suppurativa. ClinicalTrials.gov. Published 2025. Accessed December 19, 2025. https://clinicaltrials.gov/study/NCT06956235

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54. University of North Carolina at Chapel Hill. A prospective open-label trial examining the efficacy and safety of anifrolumab for hidradenitis suppurativa (HS). ClinicalTrials.gov. Published 2025. Accessed December 19, 2025. https://clinicaltrials.gov/study/NCT06374212

Disclosures: Dr. Fragoso reports the following financial disclosures: AbbVie – Investigator (Grants/Research Funding); Acelyrin – Investigator (Grants/Research Funding); Amgen – Investigator (Grants/Research Funding); Insmed Incorporated – Investigator (Grants/Research Funding); Takeda Pharmaceuticals USA Inc – Investigator (Grants/Research Funding); Target-Derm – Investigator (Grants/Research Funding); UCB Pharma – Consultant.

Andre Armero

• PhD student, MD-PhD program
• Dartmouth Geisel School of Medicine
  Hanover, NH

Natalie M. Fragoso, MD

• Assistant Professor of Dermatology, Dartmouth Geisel School of Medicine
• Department of Dermatology, Dartmouth Health
  Lebanon, NH