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REGN-2Cat

Phase 3

Allergic Conjunctivitis | Small molecule | Ophthalmology |Regeneron Pharmaceuticals, Inc.|Last Updated: Aug 12, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment570

FDA Designations

No designations recorded

Clinical trial landscape

REGN-2Cat · 1 trial · 1 indication

Phase 3 1
NCT07675811A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat AllergyAllergic Conjunctivitis
RECRUITING570 Analytics
PHASE3RECRUITING
A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy
Allergic ConjunctivitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Ocular itch score in participants receiving REGN-2Cat as compared to placebo
At day 8, post-Conjunctival Allergen Challenge (CAC)

Secondary Endpoints

1. Ocular itch score in participants receiving REGN-2Cat as compared to placebo
Up to day 85, post-CAC
2. Conjunctival redness score in participants receiving REGN-2Cat as compared to placebo
Up to day 85, post-CAC
3. Achievement of at least a 1-point reduction from baseline in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN-2Cat as compared to placebo
Up to day 85, post-CAC
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
REGN-2CatEXPERIMENTALPart A and B
FreneslerbartEXPERIMENTALPart A and B
MevonlerbartEXPERIMENTALPart A
Matching placeboPLACEBO_COMPARATORPart A and B

Interventions

NameTypeDescription
REGN-2CatDRUGAdministered per the protocol
FreneslerbartDRUGAdministered per the protocol
MevonlerbartDRUGAdministered per the protocol
PlaceboDRUGAdministered per the protocol
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Eligibility Criteria

Age Range8 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Key Inclusion Criteria: 1. Part A: adult participants aged 18 years and older. For part B: pediatric participants ≥8 years and \<18 years, and adult participants aged 18 years and older. 2. Positive SPT to cat allergen extract 3. Positive specific Immunoglobulin E (sIgE) tests for cat and Fel d 1 4...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMAug 12, 2026NCT07675811Status: NOT_YET_RECRUITING → RECRUITING
MEDIUMAug 12, 2026NCT07675811Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 30, 2026NCT07675811NEW_TRIAL: changed
LOWJun 30, 2026NCT07675811NEW_TRIAL: changed
LOWJun 30, 2026NCT07675811NEW_TRIAL: changed

Frequently asked questions about REGN-2Cat

What is REGN-2Cat used for?

REGN-2Cat is an investigational small molecule being developed for the treatment of allergic conjunctivitis, specifically in patients with cat allergy. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.

What does REGN-2Cat target?

REGN-2Cat targets Fel d 1, the major cat allergen, through monoclonal antibodies. The drug is designed to neutralize this allergen to reduce allergic responses in the eye, though the exact mechanism of action is not fully detailed in available information.

Who makes REGN-2Cat?

REGN-2Cat is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol REGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy.

What phase is REGN-2Cat in?

REGN-2Cat is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 3 trial is actively recruiting participants.

What clinical trials is REGN-2Cat in?

REGN-2Cat is being studied in a Phase 3 clinical trial with the identifier NCT07675811. This randomized, double-blind, placebo-controlled study evaluates the efficacy and safety of Fel d 1 monoclonal antibodies in adult and pediatric participants with allergic conjunctivitis due to cat allergy, enrolling 570 participants in the United States.

Is REGN-2Cat the same as Fel d 1 monoclonal antibodies?

REGN-2Cat is described as a small molecule, but the clinical trial for it uses Fel d 1 monoclonal antibodies. The drug may be referred to by this descriptive name in trial documentation, though the official drug name is REGN-2Cat.