Nemolizumab History and Updates

84 events · 2013 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 12, 2026.

FDA Approvals

Label Revisions

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-04Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Nemolizumab since 2013, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (4)

2026

Results postedNemolizumab Phase 2 PK Results Posted for Pediatric Atopic Dermatitis· May 26, 2026
Results postedNemolizumab Phase 2 Trial Shows Skin Score Improvement in Systemic Sclerosis· Feb 13, 2026

2025

Results postedNemolizumab Maintains Vaccine Response in Atopic Dermatitis, Shows Enhanced…· Jun 5, 2025
Results postedNemolizumab Shows Early Pruritus Improvement in CKD-Associated Pruritus· Feb 20, 2025

Upcoming & expected milestones

Trial startedAug 1, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07352566

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Primary completionAug 31, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT03989206

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

Primary completionSep 30, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT07074977

Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics of Nemolizumab in Adults With Chronic Pruritus of Unknown Origin (CPU

Primary completionOct 26, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT04204616

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

Primary completionJun 30, 2027· ClinicalTrials.gov

Phase 4 primary completion: NCT07396168

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

Primary completionMay 28, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT07047690

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

Primary completionDec 31, 2028· ClinicalTrials.gov

Primary completion: NCT03358693

Molecular Signatures in Inflammatory Skin Disease

Primary completionJun 1, 2030· ClinicalTrials.gov

Phase 4 primary completion: NCT07352566

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Past events

2026

Results postedMay 26, 2026· ClinicalTrials.gov

Trial results posted: NCT04921345

Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis

Trial startedFeb 20, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07047690

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

Results postedFeb 13, 2026· ClinicalTrials.gov

Trial results posted: NCT05214794

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

Trial registeredFeb 9, 2026· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07396168

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

Trial startedFeb 1, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07396168

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

Trial registeredJan 20, 2026· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07352566

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Trial startedJan 1, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07352566

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

2025

Trial startedOct 20, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT07074977

Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics of Nemolizumab in Adults With Chronic Pruritus of Unknown Origin (CPU

Trial registeredJul 20, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07074977

Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics of Nemolizumab in Adults With Chronic Pruritus of Unknown Origin (CPU

Trial registeredJul 2, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07047690

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

FDA approval (supplemental)Jun 26, 2025· FDA

FDA approved supplemental application for Nemluvio (nemolizumab-ilto) — Labeling (BLA 761390 S-2)

Sponsor: GALDERMA LABS LP. Class: Labeling.

Results postedJun 5, 2025· ClinicalTrials.gov

Trial results posted: NCT04365387

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

Primary completionApr 28, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT04921345

Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis

FDA approval (supplemental)Apr 21, 2025· FDA

FDA approved supplemental application for Nemluvio (nemolizumab-ilto) — Labeling (BLA 761390 S-1)

Sponsor: GALDERMA LABS LP. Class: Labeling.

Results postedFeb 20, 2025· ClinicalTrials.gov

Trial results posted: NCT05075408

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

Results postedJan 3, 2025· ClinicalTrials.gov

Trial results posted: NCT05405985

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

2024

Results postedDec 5, 2024· ClinicalTrials.gov

Trial results posted: NCT04562116

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

Results postedOct 8, 2024· ClinicalTrials.gov

Trial results posted: NCT05052983

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

Results postedAug 14, 2024· ClinicalTrials.gov

Trial results posted: NCT03985943

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

Results postedAug 14, 2024· ClinicalTrials.gov

Trial results posted: NCT03989349

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

FDA approvalAug 12, 2024· FDA

FDA approved Nemluvio (nemolizumab-ilto) (BLA 761390)

Sponsor: GALDERMA LABS LP. Class: Type 1 - New Molecular Entity.

Results postedJul 10, 2024· ClinicalTrials.gov

Trial results posted: NCT04501666

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

Results postedJul 10, 2024· ClinicalTrials.gov

Trial results posted: NCT04501679

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

Primary completionJun 4, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT05214794

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

Primary completionJan 4, 2024· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT05075408

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

2023

Primary completionSep 11, 2023· ClinicalTrials.gov

Phase 3 primary completion: NCT05052983

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

Primary completionJul 31, 2023· ClinicalTrials.gov

Phase 3 primary completion: NCT05056779

Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis With Inadequate Response to or for Whom Cyclosporin

Primary completionJul 7, 2023· ClinicalTrials.gov

Phase 2 primary completion: NCT04365387

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

Primary completionJun 7, 2023· ClinicalTrials.gov

Phase 2 primary completion: NCT04562116

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

Results postedApr 21, 2023· ClinicalTrials.gov

Trial results posted: NCT03921411

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

Trial startedJan 31, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05056779

Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis With Inadequate Response to or for Whom Cyclosporin

2022

Primary completionNov 11, 2022· ClinicalTrials.gov

Phase 1 primary completion: NCT05405985

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

Primary completionNov 11, 2022· ClinicalTrials.gov

Phase 3 primary completion: NCT04501666

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

Trial startedAug 11, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05405985

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

Trial registeredJun 6, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05405985

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

Trial startedApr 20, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05214794

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

Primary completionMar 30, 2022· ClinicalTrials.gov

Phase 3 primary completion: NCT04501679

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

Trial startedMar 18, 2022· ClinicalTrials.gov

Phase 2/Phase 3 trial started: NCT05075408

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

Primary completionFeb 23, 2022· ClinicalTrials.gov

Phase 3 primary completion: NCT03989349

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

Trial registeredJan 31, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05214794

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

Trial startedJan 24, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05052983

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

2021

Primary completionDec 29, 2021· ClinicalTrials.gov

Phase 3 primary completion: NCT03985943

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

Trial startedDec 8, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04562116

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

Results postedNov 22, 2021· ClinicalTrials.gov

Trial results posted: NCT01986933

A Phase 2 Study of CIM331 for Atopic Dermatitis Patients

Trial registeredOct 12, 2021· ClinicalTrials.gov

Phase 2/Phase 3 trial registered on ClinicalTrials.gov: NCT05075408

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

Trial registeredSep 27, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05056779

Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis With Inadequate Response to or for Whom Cyclosporin

Trial registeredSep 22, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05052983

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

Trial startedJun 24, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04921345

Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis

Trial registeredJun 10, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04921345

Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis

Trial startedJan 11, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT04204616

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

2020

Trial registeredSep 24, 2020· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04562116

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

Trial startedSep 11, 2020· ClinicalTrials.gov

Phase 3 trial started: NCT04501666

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

Primary completionAug 19, 2020· ClinicalTrials.gov

Phase 2 primary completion: NCT03921411

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

Trial startedAug 11, 2020· ClinicalTrials.gov

Phase 3 trial started: NCT04501679

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

Trial registeredAug 6, 2020· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04501666

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

Trial registeredAug 6, 2020· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04501679

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

Trial registeredApr 28, 2020· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04365387

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

Trial startedMar 5, 2020· ClinicalTrials.gov

Phase 2 trial started: NCT04365387

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

2019

Trial startedDec 30, 2019· ClinicalTrials.gov

Phase 3 trial started: NCT03989206

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

Trial registeredDec 19, 2019· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04204616

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

Results postedOct 22, 2019· ClinicalTrials.gov

Trial results posted: NCT03100344

Dose-ranging Study of Nemolizumab in Atopic Dermatitis

Trial startedJun 30, 2019· ClinicalTrials.gov

Phase 3 trial started: NCT03989349

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

Trial startedJun 27, 2019· ClinicalTrials.gov

Phase 3 trial started: NCT03985943

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

Trial registeredJun 18, 2019· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03989206

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

Trial registeredJun 18, 2019· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03989349

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

Trial registeredJun 14, 2019· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03985943

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

Trial registeredApr 19, 2019· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT03921411

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

Trial startedApr 9, 2019· ClinicalTrials.gov

Phase 2 trial started: NCT03921411

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

2018

Primary completionJul 19, 2018· ClinicalTrials.gov

Phase 2 primary completion: NCT03100344

Dose-ranging Study of Nemolizumab in Atopic Dermatitis

2017

Trial registeredNov 30, 2017· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT03358693

Molecular Signatures in Inflammatory Skin Disease

Trial startedJun 14, 2017· ClinicalTrials.gov

Phase 2 trial started: NCT03100344

Dose-ranging Study of Nemolizumab in Atopic Dermatitis

Trial registeredApr 4, 2017· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT03100344

Dose-ranging Study of Nemolizumab in Atopic Dermatitis

Trial startedJan 20, 2017· ClinicalTrials.gov

Trial started: NCT03358693

Molecular Signatures in Inflammatory Skin Disease

2015

Primary completionApr 30, 2015· ClinicalTrials.gov

Phase 2 primary completion: NCT01986933

A Phase 2 Study of CIM331 for Atopic Dermatitis Patients

2013

Trial startedNov 30, 2013· ClinicalTrials.gov

Phase 2 trial started: NCT01986933

A Phase 2 Study of CIM331 for Atopic Dermatitis Patients

Trial registeredNov 19, 2013· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT01986933

A Phase 2 Study of CIM331 for Atopic Dermatitis Patients

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.