Last reviewed · How we verify
Spevigo (SPESOLIMAB)
Spevigo works by blocking the interleukin-36 receptor, which plays a key role in the development of psoriasis symptoms.
At a glance
| Generic name | SPESOLIMAB |
|---|---|
| Sponsor | Boehringer Ingelheim Pharmaceuticals Inc |
| Drug class | Interleukin-36 Receptor Antagonist [EPC] |
| Target | Interleukin-1 receptor-like 2 |
| Modality | Monoclonal antibody |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2022 |
| Annual revenue | 300 |
Mechanism of action
Spesolimab-sbzo is humanized monoclonal immunoglobulin G1 antibody that inhibits interleukin-36 (IL-36) signaling by specifically binding to the IL36R. Binding of spesolimab-sbzo to IL36R prevents the subsequent activation of IL36R by cognate ligands (IL-36 and and downstream activation of pro-inflammatory and pro-fibrotic pathways. The precise mechanism linking reduced IL36R activity and the treatment of flares of GPP is unclear.
Approved indications
- Erythrodermic psoriasis
- Generalized pustular psoriasis
- Pustular psoriasis
Common side effects
- Urinary tract infection
- Upper respiratory tract infection
- Urticaria
- Subcutaneous abscess
- Vulvovaginal candidiasis
- Vulvovaginal mycotic infection
- Otitis externa
- Nausea and Vomiting
- Mild to moderate infections
- Latent tuberculosis
- Influenza
- Herpes dermatitis and oral herpes
Key clinical trials
- Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study (PHASE2)
- A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome (PHASE2,PHASE3)
- A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum (PHASE3)
- A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares (PHASE4)
- Spesolimab Post-marketing Surveillance in Korean Patients With Flares With Generalized Pustular Psoriasis
- A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab (PHASE2,PHASE3)
- A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial (PHASE2)
- Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa (PHASE2,PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Spevigo CI brief — competitive landscape report
- Spevigo updates RSS · CI watch RSS
- Boehringer Ingelheim Pharmaceuticals Inc portfolio CI