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BLU-808

Phase 2

Allergic Rhinoconjunctivitis | Small molecule | Respiratory |Blueprint Medicines Corporation|Trials Updated: Sep 3, 2026

BLU-808 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Apr 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment126

FDA Designations

No designations recorded

BLU-808 clinical trials

BLU-808 · 2 trials · 3 indications

Phase 2 2
NCT06931405Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)Chronic Inducible Urticaria
ACTIVE NOT_RECRUITING105 Analytics
NCT06922448Study of BLU-808 in Allergic RhinoconjunctivitisAllergic Rhinoconjunctivitis
COMPLETED21 Analytics
PHASE2ACTIVE NOT_RECRUITING
Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)
Chronic Inducible UrticariaUnlock trial analytics
PHASE2COMPLETED
Study of BLU-808 in Allergic Rhinoconjunctivitis
Allergic RhinoconjunctivitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Part A and Part B: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Day 1 through Week 16
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Day 1 through Day 56

Secondary Endpoints

Part A: Mean Change From Baseline in Critical Temperature Threshold (CTT) at Week 12
Baseline, Week 12
Part A: Mean Change From Baseline in Total Fric Score (TFS) at Week 12
Baseline, Week 12
Part A and Part B: Complete Response Rate
Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A1 (Part A): BLU-808EXPERIMENTALBLU-808 will be administered orally.
Arm A3 (Part A): BLU-808EXPERIMENTALBLU-808 will be administered orally.
Arm B (Part B): BLU-808/PlaceboEXPERIMENTALBLU-808 or matching placebo will be administered orally.
BLU-808 Dose 1EXPERIMENTALBLU-808 will be administered orally for 28 days.
BLU-808 Dose 2EXPERIMENTALBLU-808 will be administered orally for 28 days.
PlaceboPLACEBO_COMPARATORPlacebo will be administered orally for 28 days.

Interventions

NameTypeDescription
BLU-808DRUGOral administration
PlaceboDRUGOral administration
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites47

Key Inclusion Criteria: * Part A: Confirmed diagnosis of CIndU for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines. * Part B: Confirmed diagnosis of CSU for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihista...

Countries:United StatesDenmarkGermanyItalySpainTaiwanCanada
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Recent Changes (Last 90 Days)

MEDIUMOct 4, 2026NCT06922448TRIAL_REMOVED: changed
MEDIUMOct 4, 2026NCT06922448TRIAL_REMOVED: changed
MEDIUMOct 4, 2026NCT06922448TRIAL_REMOVED: changed

Frequently asked questions about BLU-808

What is BLU-808?

BLU-808 is an investigational small molecule being developed by Blueprint Medicines Corporation for allergic and inflammatory conditions. It is in Phase 2 clinical development for allergic rhinoconjunctivitis and for chronic inducible urticaria, including chronic spontaneous urticaria. It has not been approved by the FDA and remains under clinical study.

What is BLU-808 used for in allergic rhinoconjunctivitis?

BLU-808 is being studied as a treatment for allergic rhinoconjunctivitis, an allergic condition affecting the nose and eyes. A Phase 2 trial of BLU-808 in allergic rhinoconjunctivitis has been completed in Canada. The drug is investigational and is not approved for this or any other indication.

Who makes BLU-808?

Blueprint Medicines Corporation, which trades on the Nasdaq under the ticker BPMC, is developing BLU-808. The company is the sponsor of the clinical trials evaluating the drug in allergic rhinoconjunctivitis and in chronic urticaria. BLU-808 is an investigational small molecule and has not received FDA approval.

What phase is BLU-808 in?

BLU-808 is in Phase 2 clinical development. Two Phase 2 trials have been run: one in allergic rhinoconjunctivitis, which is completed, and one in chronic inducible urticaria and chronic spontaneous urticaria, which is active and not recruiting. BLU-808 is investigational and has not been approved by the FDA.

What clinical trials is BLU-808 in?

BLU-808 has been evaluated in two Phase 2 trials. NCT06922448 studied BLU-808 in allergic rhinoconjunctivitis in Canada and is completed. NCT06931405 is studying BLU-808 in chronic inducible urticaria and chronic spontaneous urticaria across the United States, Denmark, Germany, Italy, Spain, and Taiwan, and is active but not recruiting.

How does BLU-808 work?

BLU-808 is a small molecule drug candidate. It is being developed for allergic and urticarial conditions, including allergic rhinoconjunctivitis and chronic inducible urticaria. Its precise molecular target has not been publicly characterized in the available trial information, and it remains an investigational agent in Phase 2 testing.