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Tilrekimig

Phase 3

Atopic Dermatitis | Small molecule | Dermatology |Pfizer, Inc.|Last Updated: Sep 4, 2026

Target and mechanism

ModalitySmall molecule

Also known as tilrekimig and rHuPH20

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment1,750

FDA Designations

No designations recorded

Clinical trial landscape

Tilrekimig · 3 trials · 2 indications

Phase 3 3
NCT07772921A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe AsthmaAsthma
NOT YET_RECRUITING1,100 Analytics
NCT07783425A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe EczemaAtopic Dermatitis
NOT YET_RECRUITING1,375 Analytics
NCT07765888A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to-Severe EczemaAtopic Dermatitis
RECRUITING375 Analytics
PHASE3NOT YET_RECRUITING
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
AsthmaUnlock trial analytics
PHASE3NOT YET_RECRUITING
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic DermatitisUnlock trial analytics
PHASE3RECRUITING
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to-Severe Eczema
Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Annualized asthma exacerbation rate over 52 weeks
Baseline through Week 52

Protocol defined asthma exacerbations require treatment with systemic steroids (oral or parenteral) for 3 consecutive days or more; an emergency room or urgent care visit (\<24 hours) that is due to asthma and requires use of systemic corticosteroids as noted above; or an in-patient hospitalization (an admission to an in-patient hospital or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma.

Difference in the proportion of Eczema Area and Severity Index (EASI)75 responders between tilrekimig versus placebo.
Week 16
Difference in the proportion of validated Investigator Global Assessment- Atopic Dermatitis (vIGA-AD) 0/1 responders between tilrekimig versus placebo.
Week 16
Difference in the proportion of Eczema and Severity Index (EASI)75 responders between tilrekimig versus placebo
Week 16
Difference in the proportion of Validated Investigator Global Assessment (vIGA)-AD™ 0/1 responders between tilrekimig versus placebo
Week 16

Secondary Endpoints

Annualized asthma exacerbation rate over 52 weeks in participants with severe asthma and with eosinophil counts ≥300 cells/µL (ie, high eosinophil subgroup)
Baseline through Week 52
Annualized asthma exacerbation rate over 52 weeks in participants with severe asthma and with eosinophil counts <300 cells/µL (ie, medium-to-low eosinophil subgroup)
Baseline through Week 52
Change from baseline (CFB) in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at Week 52
Baseline through Week 52
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Arm A TilrekimigEXPERIMENTALTilrekimig
Treatment Arm B PlaceboPLACEBO_COMPARATORPlacebo
Tilrekimig - Initial treatment periodEXPERIMENTALSubcutaneous injections given over 20 Weeks.
Dupilumab - Initial treatment periodACTIVE_COMPARATORSubcutaneous injections given over 22 Weeks.
Placebo - Initial treatment periodPLACEBO_COMPARATORSubcutaneous injections given over 22 Weeks.
Tilrekimig - Maintenance Period - Dose AEXPERIMENTALSubcutaneous injections given at Week 24 through Week 48.
Tilrekimig - Maintenance Period - Dose BEXPERIMENTALSubcutaneous injections given at Week 24 through Week 48.
Placebo - Maintenance PeriodPLACEBO_COMPARATORSubcutaneous injections given at Week 24 through Week 48.
TilrekimigEXPERIMENTALSubcutaneous injections given over 20 weeks
PlaceboPLACEBO_COMPARATORSubcutaneous injections given over 20 weeks

Interventions

NameTypeDescription
tilrekimigDRUGsubcutaneous injection
PlaceboOTHERsubcutaneous injection
DupilumabDRUGSubcutaneous Injections at required timepoints based on weight and age.
Placebo for TilrekimigOTHERSubcutaneous Injections at required timepoints
Placebo for DupilumabOTHERSubcutaneous Injections at required timepoints during initial treatment period.
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Eligibility Criteria

Age Range12 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria Must meet the following asthma criteria: 1. History of persistent, severe asthma for at least 12 months prior to screening as defined by recognized international and / or local guidelines. 2. Must have experienced at least 2 asthma exacerbations requiring treatment with systemic...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMSep 4, 2026NCT07765888Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 24, 2026NCT07783425NEW_TRIAL: changed
LOWAug 24, 2026NCT07783425NEW_TRIAL: changed
LOWAug 20, 2026NCT07772921NEW_TRIAL: changed
LOWAug 20, 2026NCT07772921NEW_TRIAL: changed
LOWAug 20, 2026NCT07772921NEW_TRIAL: changed
LOWAug 20, 2026NCT07772921NEW_TRIAL: changed
LOWAug 14, 2026NCT07765888NEW_TRIAL: changed
LOWAug 14, 2026NCT07765888NEW_TRIAL: changed

Frequently asked questions about Tilrekimig

What is Tilrekimig used for?

Tilrekimig is an investigational small molecule being studied for the treatment of moderate-to-severe atopic dermatitis (eczema) and severe asthma. It is also being evaluated in healthy adults for pharmacokinetic studies. Tilrekimig is in Phase 3 clinical development and is not yet approved by regulatory authorities.

Who makes Tilrekimig?

Tilrekimig is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting multiple clinical trials to evaluate the safety and efficacy of Tilrekimig in patients with atopic dermatitis and asthma.

What phase is Tilrekimig in?

Tilrekimig is currently in Phase 3 clinical development. Pfizer has initiated several Phase 3 trials for Tilrekimig in atopic dermatitis and asthma, as well as a Phase 1 pharmacokinetic study in healthy volunteers. Tilrekimig is investigational and has not received FDA approval.

What clinical trials is Tilrekimig in?

Tilrekimig is being studied in several clinical trials. NCT07765888 and NCT07783425 are Phase 3 trials in moderate-to-severe atopic dermatitis. NCT07772921 is a Phase 3 trial in severe asthma. NCT07792941 is a Phase 1 study of single-dose pharmacokinetics in healthy adults when co-mixed with rHuPH20.

Is Tilrekimig the same as rHuPH20?

Tilrekimig is sometimes studied in combination with rHuPH20, but they are not the same drug. rHuPH20 is a recombinant human hyaluronidase that may be co-mixed with Tilrekimig in clinical trials to evaluate its pharmacokinetic profile. Tilrekimig itself is the investigational small molecule being developed by Pfizer.

How does Tilrekimig work?

The specific molecular target of Tilrekimig has not been disclosed in available clinical trial information. It is described as a small molecule being investigated for its therapeutic effects in atopic dermatitis and asthma. Further details about its mechanism of action are not publicly available at this time.