Drugs / Spesolimab
Spesolimab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed generalized pustular psoriasis 1 milestone | |||||
| Filed | US (FDA) | — | generalized pustular psoriasis | 2021-12-15 | “U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for spesolimab for the treatment of generalized pustular...” prnewswire.com ↗ “The U.S. Food and Drug Administration (FDA) accepted a Biologics License Application (BLA) and granted Priority Review for spesolimab for the treatment of GPP flares” prnewswire.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved · conditional | EU (EMA) | Spevigo | — | 2022-12-09 | europa.eu ↗ |
Trials 33
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT06520514 | Aug 2024 → Jan 2025 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT04390568 | May 2020 → Apr 2021 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT03617835 | Aug 2018 → Jun 2019 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT03123094 | May 2017 → Jan 2018 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT03100903 | Apr 2017 → Jan 2018 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02978690 | Dec 2016 → Sep 2017 | psoriasis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02852824 | Aug 2016 → Aug 2017 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02525679 | Sep 2015 → May 2016 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 217 trials · 2 met primary · 5 missed | ||||||
| Phase 2 | NCT06092216 | Sep 2023 → Jan 2025 | pyoderma gangrenosum | Icahn School of Medicine at Mount Sinai | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT05013385 | Nov 2021 → May 2022 | Crohn disease | Boehringer Ingelheim | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04876391 | Aug 2021 → Apr 2024 | hidradenitis suppurativa | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT04762277 | Apr 2021 → Jan 2022 | hidradenitis suppurativa | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2 | NCT04493424 | Sep 2020 → Jan 2023 | palmoplantar pustulosis | Boehringer Ingelheim | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04399837 | Jun 2020 → Nov 2022 | generalized pustular psoriasis | Boehringer Ingelheim | Completed | Met primary |
| Phase 2 | NCT04362254 | May 2020 → May 2022 | Crohn disease | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 2 | NCT04086121 | Sep 2019 → Apr 2021 | atopic eczema | Boehringer Ingelheim | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04015518 | Jul 2019 → Aug 2020 | palmoplantar pustulosis | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2 | NCT03886246 | May 2019 → Sep 2027 expected | generalized pustular psoriasis | Boehringer Ingelheim | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03822832 | Feb 2019 → Jan 2020 | atopic eczema | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2 | NCT03752970 | Feb 2019 → Dec 2021 | Crohn disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT03782792 | Jan 2019 → Sep 2020 | generalized pustular psoriasis | Boehringer Ingelheim | Completed | Met primary |
| Phase 2 | NCT03648541 | Oct 2018 → May 2023 | ulcerative colitis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT03123120 | Jun 2017 → Mar 2020 | ulcerative colitis | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2 | NCT03135548 | May 2017 → Jul 2018 | psoriasis | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2 | NCT03100864 | May 2017 → Aug 2019 | ulcerative colitis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2/34 trials · 3 missed | ||||||
| Phase 2/3 | NCT06241573 | May 2024 → Apr 2025 | hidradenitis suppurativa | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 2/3 | NCT05856526 | Jun 2023 → Jan 2025 | Netherton syndrome | Boehringer Ingelheim | Terminated | Missed primary |
| Phase 2/3 | NCT05819398 | Apr 2023 → Aug 2024 | hidradenitis suppurativa | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2/3 | NCT03482635 | Mar 2018 → May 2020 | ulcerative colitis | Boehringer Ingelheim | Completed | Missed primary |
| Phase 33 trials | ||||||
| Phase 3 | NCT06624670 | Feb 2025 → Nov 2027 expected | pyoderma gangrenosum | Boehringer Ingelheim | Recruiting | No outcome recorded |
| Phase 3 | NCT05239039 | Mar 2022 → Jul 2023 | generalized pustular psoriasis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT05200247 | Feb 2022 → Mar 2023 | generalized pustular psoriasis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06013969 | Oct 2023 → Jul 2026 overdue | generalized pustular psoriasis | Boehringer Ingelheim | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2025-03-07 | Boehringer Ingelheim | Results New analyses on the potential impact of SPEVIGO® in generalized pustular psoriasis patient-reported outcomes presented at AAD 2025 prnewswire.com ↗
Improvements in Psoriasis Symptom Scale (PSS), Pain Visual Analog Scale (VAS) and Dermatology Life Quality Index (DLQI) scores were observed in post-hoc exploratory analyses of the EFFISAYIL ® 2 trial |
| 2023-05-02 | Boehringer Ingelheim | Regulatory U.S. FDA Grants Breakthrough Therapy Designation for Spesolimab for the Prevention of Flares in Adults with Generalized Pustular Psoriasis (GPP) prnewswire.com ↗
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for spesolimab as an investigational treatment for the prevention of flares in adults with generalized pustular psoriasis (GPP). |
| 2023-04-06 | Boehringer Ingelheim | Regulatory Boehringer Ingelheim Receives Permanent J-Code (J1747) for SPEVIGO® (spesolimab-sbzo) Injection Effective April 1, 2023 prnewswire.com ↗
Boehringer Ingelheim announced today the U.S. Centers for Medicare & Medicaid Services (CMS) has issued a permanent J-code (J1747) for SPEVIGO (spesolimab-sbzo) Injection, indicated for the treatment of generalized pustular psoriasis (GPP) flares in adults. |
| 2022-09-01 | Boehringer Ingelheim | Regulatory FDA approves the first treatment option for generalized pustular psoriasis flares in adults prnewswire.com ↗
Boehringer Ingelheim announced today the U.S. Food and Drug Administration has approved SPEVIGO, the first approved treatment option for generalized pustular psoriasis (GPP) flares in adults. |
| 2022-03-28 | Boehringer Ingelheim | Results New spesolimab data showed significant improvement in patients with generalized pustular psoriasis (GPP) flares prnewswire.com ↗ |
| 2021-12-23 | Boehringer Ingelheim | Results Newly published results showed spesolimab significantly improved signs and symptoms of flares in rare, life-threatening skin disease, generalized pustular psoriasis prnewswire.com ↗
Boehringer Ingelheim announced today the publication in The New England Journal of Medicine of new data from the pivotal Phase II Effisayil™ 1 trial, which showed spesolimab, a first-in-class investigational treatment, significantly improved signs and symptoms of generalized pustular psoriasis (GPP) in patients experiencing a flare. |
| 2021-12-15 | Boehringer Ingelheim | Regulatory U.S. FDA grants Priority Review for spesolimab for the treatment of flares in patients with generalized pustular psoriasis (GPP), a rare, life-threatening skin disease prnewswire.com ↗
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for spesolimab for the treatment of generalized pustular psoriasis (GPP) flares. |
| 2019-03-07 | Boehringer Ingelheim | Results Novel antibody shows potential to transform treatment of rare form of psoriasis prnewswire.com ↗
The New England Journal of Medicine (NEJM) today published new data from a Phase I clinical trial showing BI 655130, a first-in-class investigational treatment, significantly improved symptoms of generalized pustular psoriasis (GPP), a rare form of psoriasis. |
All press releases naming this drug 8 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 36 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Spesolimab | “Spesolimab is a humanized anti-IL-36 monoclonal antibody inhibiting the IL-36 signalling pathway.” PMID 39039387 ↗ Jul 2024 |
| Known as | BI 655130 | “The primary objective of this trial is to investigate the safety and efficacy of BI 655130 in patients with PPP following multiple intravenous administrations compared to placebo.” NCT03135548 ↗9“Multi-center, Double-blind, Randomized, Placebo-controlled, Phase IIa Trial to Evaluate Spesolimab (BI 655130) Efficacy in Patients With Fibrostenotic Crohn's Disease” NCT05013385 ↗ “Evaluate Safety and Efficacy of Spesolimab (BI 655130) in Adult Patients With Ulcerative Pyoderma Gangrenosum (PG) Who Require Systemic Therapy” NCT06624670 ↗ “A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis” NCT04399837 ↗ “clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis” NCT03482635 ↗ “BI 655130 (spesolimab)” NCT02852824 ↗ |
| Known as | Espesolimab | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297911 ↗ |
| Known as | Spesolimab sbzo | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297911 ↗ |
| Known as | Spevigo | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297911 ↗ |
| Action | Inhibit | “antagonizes IL-36 signaling” PMID 39104539 ↗ Jul 2024 |
| Modality | Monoclonal antibody | “Anti-interleukin-36 Receptor Monoclonal Antibody” PMID 36451029 ↗ Dec 2022 |
| Route | Intravenous | “administered by intravenous infusion” PMID 36451029 ↗ Dec 2022 |