Spevigo

(Spesolimab)

ApprovedMonoclonal antibody

Spesolimab is used to treat flare-ups of generalized pustular psoriasis, a severe skin condition where painful pus-filled bumps cover large areas of the body.[2] Spevigo is currently approved and in use across 6 indications[4].[1]

Spevigo is one of 116 monoclonal antibody programs targeting Psoriasis. It is currently in Approved.

Indications

Total Trials

Active Trials

115

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

PsoriasisUnknown

Immune System DiseaseUnknown

Pustular PsoriasisUnknown

Generalized Pustular PsoriasisActive, not recruiting

Psoriasis VulgarisUnknown

Pyoderma GangrenosumRecruiting

PsoriasisPreclinical

Unknown

Immune System DiseasePreclinical

Unknown

Pustular PsoriasisPreclinical

Unknown

Generalized Pustular PsoriasisApproved

Active, not recruiting

Psoriasis VulgarisPreclinical

Unknown

Pyoderma GangrenosumPhase 3

Recruiting

Competition

Competitive Landscape

107 competitors in Psoriasis

#DrugCompanyPhaseTrials

Spevigo

Boehringer Ingelheim

Approved

28 2

Daliresp

AstraZeneca

Phase 3

5 3

D-2570

IInventisBio Co., Ltd

Phase 3

4 4

TAK-279

Takeda

Phase 3

3 5

Ponvory

VVanda Pharmaceuticals

Phase 3

1 6

SYHX1901

CCSPC Ouyi Pharmaceutical Co., Ltd.

Phase 3

2 7

Vunakizumab (IL-17A Inhibitor)

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Phase 3

1 8

SHR-1314

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Phase 3

4 9

HS-10374

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Phase 3

3 10

ICP-488

BBeijing InnoCare Pharma Tech Co., Ltd.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2028

Phase 2Active, not recruiting

Generalized Pustular Psoriasis

NCT03886246

Q3 2028

Phase 3Recruiting

Pyoderma Gangrenosum

NCT06624670

Clinical

Trials by Indication[1]

Generalized Pustular Psoriasis7 trials

A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT04399837·123 enrolled

An Expanded Access Program in China to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT05239039·39 enrolled

Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT03782792·53 enrolled

Show 4 more trials

An Expanded Access Trial in Japan to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT05200247·11 enrolled

Spesolimab (BI 655130) Single Dose in Generalized Pustular Psoriasis

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02978690·7 enrolled

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 recruiting· Boehringer Ingelheim logo

Boehringer Ingelheim·Approved·NCT06013969·42 enrolled

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)

Active, not recruiting· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT03886246·131 enrolled

Ulcerative Colitis4 trials

BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2/3·NCT03482635·98 enrolled

BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT03648541·79 enrolled

This Study Tests How BI 655130 Works in Patients With Active Ulcerative Colitis. The Study Also Tests How Well BI 655130 is Tolerated and Whether it Helps the Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT03100864·8 enrolled

Show 1 more trial

A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT03123120·22 enrolled

Hidradenitis Suppurativa4 trials

Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2/3·NCT05819398·209 enrolled

A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT04762277·52 enrolled

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

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2/3·NCT06241573·39 enrolled

Show 1 more trial

A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT04876391·45 enrolled

Crohn's Disease3 trials

A Study to Test Whether Spesolimab Helps People With Crohn's Disease Who Have Symptoms of Bowel Obstruction

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT05013385·5 enrolled

A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT04362254·12 enrolled

A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's Disease

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT03752970·27 enrolled

Palmoplantar Pustulosis3 trials

A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT04015518·152 enrolled

Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT03135548·59 enrolled

A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT04493424·108 enrolled

6 more indications

Pyoderma Gangrenosum2 trials

Spesolimab in Pyoderma Gangrenosum

Terminated·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT06092216·5 enrolled

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

Recruiting· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT06624670·90 enrolled

Acute1 trial

PMS of Spesolimab I.V. in GPP Patients With Acute Symptoms

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT05670821·52 enrolled

Trial1 trial

Single Rising Dose Trial of Spesolimab (BI 655130) for Healthy Japanese Male Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT03123094·32 enrolled

Netherton syndrome1 trial

A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2/3·NCT05856526·43 enrolled

Atopic Eczema1 trial

A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT04086121·14 enrolled

Unspecified1 trial

A Study to Test How Well Healthy People Tolerate Spesolimab When Given in 2 Different Ways

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT06520514·60 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 1, 2022

SPEVIGO

NDA BLA761244

Mar 18, 2024

SPEVIGO

NDA BLA761244

May 28, 2025

SPEVIGO

NDA BLA761244

May 28, 2025

SPEVIGO

NDA BLA761244

Oct 21, 2025

SPEVIGO

NDA BLA761244

Sources

References

[1]
ClinicalTrials.gov — 28 trial records for Spesolimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Spevigo drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Spesolimab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Spesolimab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA761244). U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Spesolimab. U.S. National Library of Medicine.
[7]
SEC EDGAR — Boehringer Ingelheim company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: IL-36R Inhibitor[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: Boehringer Ingelheim

Key Publications[6]

Spesolimab for Generalized Pustular Psoriasis Flares

N Engl J MedOct 27, 2022DOI: 10.1056/NEJMoa2111563

Spevigo

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2028

Q3 2028

Trials by Indication[1]

Generalized Pustular Psoriasis7 trials

Ulcerative Colitis4 trials

Hidradenitis Suppurativa4 trials

Crohn's Disease3 trials

Palmoplantar Pustulosis3 trials

Pyoderma Gangrenosum2 trials

Acute1 trial

Trial1 trial

Netherton syndrome1 trial

Atopic Eczema1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Key Publications[6]

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