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Drug

Spesolimab

Approved medicine
ResearchOngoing clinical research

Also known as Spevigo, Immunoglobulin G1, anti-(human interleukin 36 receptor) (humanized monoclonal BI 655130 gamma1-chain), disulfide with humanized monoclonal BI 655130 kappa-chain, dimer.

RxNorm2610417ChEMBLCHEMBL4297911ATCL04AC22UNII5IB2J79MCX
3
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Multi-centre, Randomised, Placebo-controlled, Double-blind, Parallel-group Trial to Evaluate Safety and Efficacy of Spesolimab (BI 655130) in Adult Patients With Ulcerative Pyoderma Gangrenosum (PG) Who Require Systemic Therapy

Clinical trial2026-08-03Results expected Q4 2027 · ClinicalTrials.gov

Effisayil® REP:An Open-label, Multicenter, Single-arm, Post-marketing Trial (in Select Countries) to Evaluate Efficacy and Safety and the Impact of Immunogenicity on Efficacy, Safety, and Pharmacokinetics of Spesolimab i.v. in Treatment of Patients With Generalized Pustular Psoriasis (GPP) Presenting With a Recurrent Flare Following Their Initial GPP Flare Treatment With Spesolimab i.v.

Clinical trial2026-07-23Primary completion · ClinicalTrials.gov

Effisayil™ ON: An Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Spesolimab Treatment in Patients With Generalized Pustular Psoriasis (GPP)

Clinical trial2026-03-31Results expected Q3 2027 · ClinicalTrials.gov

An Open-label, Long-term Extension Trial of Spesolimab Treatment in Adult Patients With Hidradenitis Suppurativa (HS)

Clinical trial2025-11-14Results posted · ClinicalTrials.gov

An Open Label, Long Term Safety Trial of BI 655130 (SPESOLIMAB) Treatment in Patients With Moderate to Severely Active Ulcerative Colitis Who Have Completed Previous BI 655130 Trials

Clinical trial2025-10-20Results posted · ClinicalTrials.gov

Effisayil™ 2: Multi-center, Randomized, Parallel Group, Double Blind, Placebo Controlled, Phase IIb Dose-finding Study to Evaluate Efficacy and Safety of BI 655130 (Spesolimab) Compared to Placebo in Preventing Generalized Pustular Psoriasis (GPP) Flares in Patients With History of GPP.

Clinical trial2025-10-20Results posted · ClinicalTrials.gov

Multi-centre, Open-label, Expanded Access Program of 900mg Intravenous (i.v.) Spesolimab in Patients With Generalized Pustular Psoriasis (GPP) Presenting With a Flare

Clinical trial2025-10-20Results posted · ClinicalTrials.gov

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in Patients With Moderate-to-severely Active Ulcerative Colitis Who Have Failed Previous Biologics Therapy

Clinical trial2025-10-16Results posted · ClinicalTrials.gov

Effisayil™ 1:Multi-center, Double-blind, Randomised, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety and Tolerability of a Single Intravenous Dose of Spesolimab (BI 655130) in Patients With Generalized Pustular Psoriasis (GPP) Presenting With an Acute Flare of Moderate to Severe Intensity

Clinical trial2025-10-16Results posted · ClinicalTrials.gov

Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment With BI 655130 in Patients With Active Ulcerative Colitis (UC)

Clinical trial2025-10-16Results posted · ClinicalTrials.gov

Mechanism of Action and Clinical Effect of BI 655130 in Patients With Fistulizing Crohn's Disease

Clinical trial2025-10-16Results posted · ClinicalTrials.gov

Approval: Spevigo (EMA)

Regulatory2022-12-09EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Spesolimab
Aliases & brands
SpevigoImmunoglobulin G1, anti-(human interleukin 36 receptor) (humanized monoclonal BI 655130 gamma1-chain), disulfide with humanized monoclonal BI 655130 kappa-chain, dimer
RxNorm CUI
2610417
ChEMBL ID
CHEMBL4297911
ATC codes
L04AC22
UNII
5IB2J79MCX
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2022-12-09
Latest approval
2022-12-09
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2022-12-09Approval
Approval: Spevigo (EMA)
Indication: Spevigo is indicated for the prevention of generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age. Spevigo is indicated for the treatment of… Show full indication

Spevigo is indicated for the prevention of generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age. Spevigo is indicated for the treatment of generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age as monotherapy.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

24 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
24
registered trials across all phases
LATEST COMPLETION 2025
3
Active studies
1
Recruiting
6
Late-stage (III+)
15
Completed
6
Discontinued
PHASE DISTRIBUTIONn = 24
Phase 13Phase 215Phase 2 / 32Phase 33Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Effisayil® REP:An Open-label, Multicenter, Single-arm, Post-marketing Trial (in Select Countries) to Evaluate Efficacy and Safety and the Impact of Immunogenicity on Efficacy, Safety, and Pharmacokinetics of Spesolimab i.v. in Treatment of Patients With Generalized Pustular Psoriasis (GPP) Presenting With a Recurrent Flare Following Their Initial GPP Flare Treatment With Spesolimab i.v.

Active, not recruitingPH IVBoehringer Ingelheimn=422026

A Multi-centre, Randomised, Placebo-controlled, Double-blind, Parallel-group Trial to Evaluate Safety and Efficacy of Spesolimab (BI 655130) in Adult Patients With Ulcerative Pyoderma Gangrenosum (PG) Who Require Systemic Therapy

RecruitingPH IIILEO Pharman=902028

Lunsayil LTE: An Extension Trial Assessing Long-term Spesolimab Treatment in Patients With Hidradenitis Suppurativa (HS)

TerminatedPH II/IIIBoehringer Ingelheimn=392025

Multi-centre, Open-label, Expanded Access Program of 900mg Intravenous (i.v.) Spesolimab in Patients With Generalized Pustular Psoriasis (GPP) Presenting With a Flare

CompletedPH IIIBoehringer Ingelheimn=392023

Multi-centre, Open-label, Expanded Access Trial of Spesolimab i.v. in Patients With Generalized Pustular Psoriasis (GPP) Presenting With a Flare

CompletedPH IIIBoehringer Ingelheimn=112023

Recent completions

Trials that read out recently, adding to the completed evidence base.

Safety, Tolerability, and Relative Bioavailability of a Single Dose of Spesolimab Via Two Subcutaneous Modes of Delivery in Healthy Subjects (Mono-centric, Randomised, Parallel Group Design)

CompletedPH IBoehringer Ingelheimn=602025

An Open-label, Long-term Extension Trial of Spesolimab Treatment in Adult Patients With Hidradenitis Suppurativa (HS)

CompletedPH IIBoehringer Ingelheimn=452024

Multi-centre, Open-label, Expanded Access Program of 900mg Intravenous (i.v.) Spesolimab in Patients With Generalized Pustular Psoriasis (GPP) Presenting With a Flare

CompletedPH IIIBoehringer Ingelheimn=392023

An Open Label, Long Term Safety Trial of BI 655130 (SPESOLIMAB) Treatment in Patients With Moderate to Severely Active Ulcerative Colitis Who Have Completed Previous BI 655130 Trials

CompletedPH IIBoehringer Ingelheimn=792023

Multi-centre, Open-label, Expanded Access Trial of Spesolimab i.v. in Patients With Generalized Pustular Psoriasis (GPP) Presenting With a Flare

CompletedPH IIIBoehringer Ingelheimn=112023

Effisayil™ 2: Multi-center, Randomized, Parallel Group, Double Blind, Placebo Controlled, Phase IIb Dose-finding Study to Evaluate Efficacy and Safety of BI 655130 (Spesolimab) Compared to Placebo in Preventing Generalized Pustular Psoriasis (GPP) Flares in Patients With History of GPP.

CompletedPH IIBoehringer Ingelheimn=1232022
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.