Spevigo(spesolimab)
Spevigo (spesolimab) is an antibody pharmaceutical. Spesolimab was first approved as Spevigo on 2022-09-01. It is used to treat psoriasis in the USA. It has been approved in Europe to treat psoriasis.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Spevigo
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Spesolimab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Spevigo | spesolimab-sbzo | Boehringer Ingelheim | N-761244 RX | 2022-09-01 | 3 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| spevigo | Biologic Licensing Application | 2025-10-27 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| psoriasis | EFO_0000676 | D011565 | L40 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
spesolimab, Spevigo, Boehringer Ingelheim Pharmaceuticals, Inc. | |||
| 2029-09-01 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
35 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriasis | D011565 | EFO_0000676 | L40 | 1 | 6 | 2 | 1 | 2 | 12 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hidradenitis suppurativa | D017497 | — | L73.2 | — | 4 | 2 | — | — | 4 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | 4 | 1 | — | — | 4 |
| Pyoderma gangrenosum | D017511 | EFO_0006835 | L88 | — | 1 | 1 | — | — | 2 |
| Netherton syndrome | D056770 | — | — | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 3 | — | — | — | 3 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | 2 | — | — | — | 2 |
| Dermatitis | D003872 | — | L30.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 7 | — | — | — | — | 7 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Spesolimab |
| INN | spesolimab |
| Description | Spesolimab, sold under the brand name Spevigo, is a monoclonal antibody used for the treatment of generalized pustular psoriasis (GPP). It is an interleukin-36 receptor (IL-36R) antagonist. It is given via injection into a vein.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 2097104-58-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297911 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB15626 |
| UNII ID | 5IB2J79MCX (ChemIDplus, GSRS) |
Target
No data
Variants
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Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 427 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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288 adverse events reported
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