nemolizumab

mAbapprovedBreakthrough Therapy FDA

Approved

Aug 12, 2024

Nemolizumab, sold under the brand name Nemluvio, is a humanized monoclonal antibody used for the treatment of prurigo nodularis and atopic dermatitis. It is a monoclonal antibody that blocks the interleukin-31 receptor A. Nemolizumab is humanized IgG2 monoclonal antibody that inhibits interleukin-31 signaling by binding selectively to interleukin-31 receptor alpha. It is an interleukin-31 receptor antagonist. IL-31 is a cytokine involved in pruritus, inflammation, epidermal dysregulation and fibrosis. By inhibiting IL-31-induced responses, nemolizumab prevents the release of proinflammatory cytokines and chemokines. — Wikipedia

Clinical trial activity

20 trials · 3 clinical orgs · 2 marketing orgs

Phase 1
1
Phase 2
18
Phase 3
9
Phase 4
0

Earliest trial started Nov 1, 2013 (NCT01986933)

Timeline

2010s

  1. Jan 1, 2013

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2019

    Galderma — Earliest Phase 3 Sponsor(trial)

2020s

  1. Jan 1, 2022

    Galderma — Earliest Phase 1 Sponsor(trial)

  2. Aug 12, 2024

    Nestle — Earliest FDA Approval

  3. Aug 12, 2024

    Galderma — Marketing Organization

  4. Aug 12, 2024

    Nestle — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewBreakthroughAug 12, 2024

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

First in class

Sources

Also known as

  • cim331
  • nemolizumab
  • nemolizumab

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07047690Phase 2Dec 15, 2025Galderma
NCT07074977Phase 2Sep 30, 2025Galderma
NCT05405985Phase 1Aug 11, 2022Galderma
NCT05214794Phase 2Apr 20, 2022Maruho Co., Ltd.
NCT05052983Phase 3Jan 31, 2022Galderma
NCT05056779Phase 3Jan 31, 2022Galderma
NCT05075408Phase 2/Phase 3 (Phase 3)Dec 31, 2021Galderma
NCT04921345Phase 2Jun 24, 2021Galderma
NCT04562116Phase 2Oct 12, 2020Galderma
NCT04501666Phase 3Sep 11, 2020Galderma
NCT04501679Phase 3Aug 11, 2020Galderma
NCT04204616Phase 3Apr 1, 2020Galderma
NCT04365387Phase 2Mar 5, 2020Galderma
NCT03989349Phase 3Jun 30, 2019Galderma
NCT03985943Phase 3Jun 30, 2019Galderma
NCT03989206Phase 3Jun 28, 2019Galderma
NCT03921411Phase 2Apr 9, 2019Galderma
NCT03181503Phase 2Aug 28, 2017Galderma
NCT03100344Phase 2Jun 1, 2017Galderma
NCT01986933Phase 2Nov 1, 2013Chugai
Showing 20 of 20 trials
Page 1 / 1

Organizations

Research & Development (3)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GaldermaFor profit181832017
ChugaiFor profit1112013
Maruho Co., Ltd.For profit1112022
3 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
GaldermaFor profitMKTGAug 12, 2024
NestleFor profitNDAAug 12, 2024