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Rezzayo

(Nemolizumab)

ApprovedMonoclonal antibody

Nemolizumab is used to treat moderate to severe atopic dermatitis (eczema), a skin condition that causes intense itching and inflammation. It works by blocking a specific immune system protein that contributes to the disease.[2] Rezzayo is currently approved and in use across 12 indications[4].[1]

Rezzayo is one of 142 monoclonal antibody programs targeting Systemic Sclerosis. It is currently in Approved.

12

Indications

25

Total Trials

10

Active Trials

141

Competitors

3

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Systemic SclerosisCompleted

Skin DiseaseActive, not recruiting

Atopic EczemaUnknown

Eczematoid DermatitisUnknown

PrurigoUnknown

Lichen SclerosusNot yet recruiting

Chronic PruritusActive, not recruiting

Atopic DermatitisNot yet recruiting

Prurigo NodularisCompleted

Lichen PlanopilarisRecruiting

Systemic SclerosisPhase 2

Completed

Skin DiseasePreclinical

Active, not recruiting

Atopic EczemaPreclinical

Unknown

Eczematoid DermatitisPreclinical

Unknown

PrurigoPreclinical

Unknown

Lichen SclerosusPhase 2

Not yet recruiting

Chronic PruritusPhase 2

Active, not recruiting

Atopic DermatitisApproved

Not yet recruiting

Prurigo NodularisPhase 3

Completed

Lichen PlanopilarisApproved

Recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

127 competitors in Atopic Dermatitis

#DrugCompanyPhaseTrials

Rezzayo

Cytosar

Fludara

Adtralza

Amlitelimab

Certolizumab

Johnson & Johnson

DUPIXENT

Jaktinib

SSuzhou Zelgen Biopharmaceuticals Co.,Ltd

ICP-332

BBeijing InnoCare Pharma Tech Co., Ltd.

VC005

JJiangsu vcare pharmaceutical technology co., LTD

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

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Prurigo Nodularis

NCT04204616

Q1 2027

Phase 2Active, not recruiting

Chronic Pruritus

NCT07074977

Q2 2027

Post-ApprovalRecruiting

Lichen Planopilaris

NCT07396168

Q4 2027

Phase 2Not yet recruiting

Lichen Sclerosus

NCT07704775

Clinical

Trials by Indication[1]

Atopic Dermatitis11 trials

A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab

Completed·GGalderma R&D·Phase 2·NCT04365387·242 enrolled

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Not yet recruiting·UUniversity of California, San Francisco·Phase 4·NCT07352566·10 enrolled

Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis

Active, not recruiting·GGalderma R&D·Phase 3·NCT03989206·1,700 enrolled

Show 8 more trials

Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis With Inadequate Response to or for Whom Cyclosporine A is Not Medically Advisable

Withdrawn·GGalderma R&D·Phase 3·NCT05056779

A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD)

Completed·GGalderma R&D·Phase 2·NCT03921411·20 enrolled

A Phase 2 Study of CIM331 for Atopic Dermatitis Patients

Completed· Roche logo

Roche·Phase 2·NCT01986933·264 enrolled

Dose-ranging Study of Nemolizumab in Atopic Dermatitis

Completed·GGalderma R&D·Phase 2·NCT03100344·226 enrolled

Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

Completed·GGalderma R&D·Phase 3·NCT03985943·941 enrolled

A Study to Assess the Effects of Nemolizumab on Cytochrome P450 Substrates in Participants With Moderate-to-Severe Atopic Dermatitis

Completed·GGalderma R&D·Phase 2·NCT04562116·17 enrolled

Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

Completed·GGalderma R&D·Phase 3·NCT03989349·787 enrolled

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Chinese Subjects With Moderate-to-Severe Atopic Dermatitis

Not yet recruiting·GGalderma R&D·Phase 3·NCT07762833·240 enrolled

Prurigo Nodularis4 trials

A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

Completed·GGalderma R&D·Phase 3·NCT04501679·274 enrolled

A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

Active, not recruiting·GGalderma R&D·Phase 3·NCT04204616·500 enrolled

A Study to Evaluate the Durability of Response and Safety of Nemolizumab for 24 Weeks in Participants With Prurigo Nodularis

Completed·GGalderma R&D·Phase 3·NCT05052983·34 enrolled

Show 1 more trial

Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

Completed·GGalderma R&D·Phase 3·NCT04501666·286 enrolled

Systemic Sclerosis2 trials

A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis

Not yet recruiting·GGalderma R&D·Phase 2·NCT07047690·162 enrolled

An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis

Completed·MMaruho Co., Ltd.·Phase 2·NCT05214794·6 enrolled

Moderate to Severe Atopic Dermatitis2 trials

A Multicenter, Open-Label, Single-Group Clinical Study to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab in Pediatric Subjects (Aged 6 to 23 Months) With Moderate-to-Severe Atopic Dermatitis Not Adequately Controlled With Topical Therapy

Recruiting·GGalderma R&D·Phase 2·NCT07660835·35 enrolled

A Multicenter, Open-Label, Single-Group Clinical Trial to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab (CD14152) in Pediatric Subjects (Aged 2 to 11 Years) With Moderate-to-Severe Atopic Dermatitis

Completed·GGalderma R&D·Phase 2·NCT04921345·109 enrolled

ESS1 trial

Study to Access the Relative Bioavailability of Subcutaneous Dose of Nemolizumab When Administered Via Auto-Injector Versus Dual-Chamber Syringe

Completed·GGalderma R&D·Phase 1·NCT05405985·192 enrolled

5 more indications

Lichen Planopilaris1 trial

Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled, Prospective, Pilot Study.

Recruiting·TThe Skin Center Dermatology Group·Phase 4·NCT07396168·10 enrolled

Skin Disease1 trial

Molecular Signatures in Inflammatory Skin Disease

Recruiting·PProf. Dr. Stephan Weidinger··NCT03358693·300 enrolled

Chronic Kidney Disease1 trial

To Evaluate the Efficacy and Safety of Nemolizumab for 12 Weeks in Participants With Chronic Kidney Disease With Associated Moderate to Severe Pruritus

Completed·GGalderma R&D·Phase 2/3·NCT05075408·258 enrolled

Chronic Pruritus1 trial

An Exploratory Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics (PK/PD) of Nemolizumab in Adult Participants With Chronic Pruritus of Unknown Origin (CPUO)

Active, not recruiting·GGalderma R&D·Phase 2·NCT07074977·50 enrolled

Lichen Sclerosus1 trial

Nemolizumab for the Treatment of Lichen Sclerosus

Not yet recruiting·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT07704775·25 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 22, 2023

REZZAYO

NDA NDA217417

Dec 10, 2025

REZZAYO

NDA NDA217417

Jul 16, 2026

REZZAYO

NDA NDA217417

Sources

References

[1]
ClinicalTrials.gov — 25 trial records for Nemolizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Rezzayo drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Nemolizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Nemolizumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA217417). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: IL-31 Receptor Antagonist[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: Roche

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