Hidradenitis Suppurativa Clinical Trial Analysis: Key Insights Into Rich Pipeline Featuring 24+ Companies And 26+ Therapies Delveinsight
| Drugs | Company | Phase | MoA | RoA |
| INCB54707 | Incyte Corporation | III | Janus kinase 1 inhibitors | Oral |
| Sonelokimab | MoonLake Immunotherapeutics | III | IL17A protein inhibitors; IL17F protein inhibitors | Subcutaneous |
| LY3041658 | Eli Lilly and Company | II | Chemokine inhibitors | Subcutaneous |
| INF904 | InflaRx | II | Complement C5a receptor antagonists | Oral |
| LT 002 158 | Leadingtac Pharmaceutical | I/II | IRAK4 degraders | Oral |
| HB0043 | Shanghai Huaota Biopharmaceutical Co., Ltd. | I/II | IL17A protein inhibitors; Interleukin 36 receptor antagonists | Intravenous |
| SBT 77 7101 | Sonoma Biotherapeutics, Inc. | I | Regulatory T-lymphocyte replacements | Parenteral |
Recent Developments in Hidradenitis Suppurativa Treatment Space
- In September 2025, MoonLake Immunotherapeutics announced the week 16 results of the Phase III VELA-1 and VELA-2 trials of its registrational global program for Sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (HS). In September 2025, Sanofi announced new data from the HS-OBTAIN phase IIa study, showing that treatment with brivekimig led to clinically meaningful improvements in the primary endpoint of Hidradenitis Suppurativa Clinical Response (HiSCR50) in patients naïve to biologics with moderate-to-severe hidradenitis suppurativa (HS). Brivekimig was well tolerated, with no serious adverse events. The results will be shared in an oral presentation at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris. In May 2025, Zura Bio Limited announced the launch of TibuSHIELD, a global Phase II clinical study evaluating tibulizumab in adults with moderate to severe HS. TibuSHIELD is designed to enroll approximately 180 adults with moderate to severe HS across the United States, Canada, and Europe. The study will evaluate tibulizumab over a 28-week period, comprising a 16-week primary efficacy assessment and a 12-week safety follow-up, with an optional OLE. In March 2025, Incyte announced positive topline results from its pivotal Phase III STOP-HS clinical trial program evaluating the safety and efficacy of povorcitinib, an oral small-molecule JAK1 inhibitor, in adult patients (≥18 years) with moderate to severe hidradenitis suppurativa (HS). In December 2024, Ikena Oncology, Inc. and Inmagene Biopharmaceuticals announced they have entered into a definitive merger agreement. In connection with the merger, Ikena has entered into subscription agreements for a USD 75 million private placement. The combined company will focus on the development of IMG-007, a monoclonal antibody (mAb) targeting OX40. The combined company plans to operate under the name“ImageneBio, Inc.” and trade on NASDAQ under the ticker“IMA”. IMG-007 is a mAb targeting OX40 with potential utility in a wide range of inflammatory indications, including atopic dermatitis, asthma, hidradenitis suppurativa, systemic sclerosis and others. In July 2024, Avalo Therapeutics, Inc. announced that the Investigational New Drug (IND) for AVTX-009, an anti-IL-1β monoclonal antibody (mAb), for the treatment of hidradenitis suppurativa (HS) is now active, permitting the Company to commence its Phase II (LOTUS) clinical trial in patients with HS.
Scope of the Hidradenitis Suppurativa Pipeline Report
- Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Janus kinase 1 inhibitors, IL17A protein inhibitors; IL17F protein inhibitors, Chemokine inhibitors, Complement C5a receptor antagonists, IRAK4 degraders, Interleukin 36 receptor antagonists, Regulatory T-lymphocyte replacements Key Hidradenitis Suppurativa Companies: InflaRx, MoonLake TX, Incyte Corporation, Avalo Therapeutics, Inc., Eli Lilly and Company, Sanofi, Merck Sharp & Dohme LLC, Almirall S.A., Insmed Incorporated, Citryll BV, Sonoma Biotherapeutics, Inc., Zura Bio, Shanghai Huaota Biopharmaceutical Co., Ltd., Leadingtac Pharmaceutical, AbbVie, Boehringer Ingelheim, and others. Key Hidradenitis Suppurativa Pipeline Therapies: INF904, Sonelokimab, INCB54707, AVTX 009, LY3041658, Brivekimig, Tulisokibart, LAD191, Brensocatib, CIT-013, SBT777101, Tibulizumab, HB0043, LT 002 158, Upadacitinib, Spesolimab, and others.
Table of Contents
| 1. | Hidradenitis Suppurativa Pipeline Report Introduction |
| 2. | Hidradenitis Suppurativa Pipeline Report Executive Summary |
| 3. | Hidradenitis Suppurativa Pipeline: Overview |
| 4. | Analytical Perspective In-depth Commercial Assessment |
| 5. | Hidradenitis Suppurativa Clinical Trial Therapeutics |
| 6. | Hidradenitis Suppurativa Pipeline: Late-Stage Products (Pre-registration) |
| 7. | Hidradenitis Suppurativa Pipeline: Late-Stage Products (Phase III) |
| 8. | Hidradenitis Suppurativa Pipeline: Mid-Stage Products (Phase II) |
| 9. | Hidradenitis Suppurativa Pipeline: Early-Stage Products (Phase I) |
| 10. | Hidradenitis Suppurativa Pipeline Therapeutics Assessment |
| 11. | Inactive Products in the Hidradenitis Suppurativa Pipeline |
| 12. | Company-University Collaborations (Licensing/Partnering) Analysis |
| 13. | Key Companies |
| 14. | Key Products in the Hidradenitis Suppurativa Pipeline |
| 15. | Unmet Needs |
| 16. | Market Drivers and Barriers |
| 17. | Future Perspectives and Conclusion |
| 18. | Analyst Views |
| 19. | Appendix |
Related Reports
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