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UPB-101

Phase 2

Asthma | Small molecule | Respiratory |Upstream Bio, Inc.|Trials Updated: Sep 18, 2026

UPB-101 development status

Highest phase Phase 2 (NCT06966479)
Phase scored for UPBPhase 1
Registered trials 4 across 1 sponsor since Jul 2022

UPB-101 target and mechanism

ModalitySmall molecule

Also known as Formerly ASP7266, Verekitug

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials5
Total Enrollment1,654

FDA Designations

No designations recorded

UPB-101 clinical trials

UPB-101 · 5 trials · 4 indications

Phase 2 4Phase 1 1
NCT06981078A Study to Assess the Efficacy and Safety of Verekitug in Participants With COPDChronic Obstructive Pulmonary Disease
ACTIVE NOT_RECRUITING666 Analytics
NCT06966479A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALOUR)Severe Asthma
ACTIVE NOT_RECRUITING396 Analytics
NCT06196879A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)Severe Asthma
COMPLETED479 Analytics
NCT06164704A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Participants With Chronic Rhinosinusitis With Nasal PolypsChronic Rhinosinusitis With Nasal Polyps
COMPLETED81 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Study to Assess the Efficacy and Safety of Verekitug in Participants With COPD
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics
PHASE2ACTIVE NOT_RECRUITING
A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALOUR)
Severe AsthmaUnlock trial analytics
PHASE2COMPLETED
A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)
Severe AsthmaUnlock trial analytics
PHASE2COMPLETED
A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Participants With Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal PolypsUnlock trial analytics

Study Endpoints

Primary Endpoints

Annualized rate of moderate or severe COPD exacerbation events
From Day 1 (Baseline) up to Week 108
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
From VALOUR baseline up to Week 64

An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Annual Asthma Exacerbation Rate (AAER)
Baseline up to Week 60

An asthma exacerbation is defined as a worsening of asthma that required treatment with systemic (oral or intravenous) corticosteroids for at least three consecutive days or a single depo-injectable dose of corticosteroids or an emergency room (ER) or urgent care visit that required systemic corticosteroids or an admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for greater than or equal to 24 hours.

Change From Baseline in Nasal Polyp Score (NPS) at Week 24
Baseline, Week 24

NPS is a physician-reported scoring system to estimate the extent or severity of nasal polyps (NPs) based on assessments by nasal endoscopy. Each nostril is scored on a categorical scale of 0 to 4 with a lower score indicating smaller-sized nasal polyps. The total score is the sum of the right and left scores (0-8). A higher score means more severe disease.

Number of Treatment-emergent Adverse Events and Serious Adverse Events
Baseline through 24 weeks

Overall Summary of Treatment-emergent Adverse Events (TEAEs) and Adverse Events (AEs) up to Week 24 (Safety Population)

Secondary Endpoints

Change in pre-bronchodilator forced expiratory capacity in 1 second (FEV1)
From Day 1 (Baseline) to Week 60
Annualized rate of severe COPD exacerbation events
From Day 1 (Baseline) up to Week 108
Change in St. George's Respiratory Questionnaire (SGRQ) total score
From Day 1 (Baseline) to Week 60
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Verekitug (UPB-101) 100 mg and PlaceboEXPERIMENTALParticipants will receive 0.5 milliliter (mL) of the formulated solution (containing 100 milligrams \[mg\] of verekitug \[UPB-101\]) and 2.0 mL of matching placebo subcutaneously in two separate injections every 12 weeks up to Week 96.
Verekitug (UPB-101) 400 mg and PlaceboEXPERIMENTALParticipants will receive 2.0 mL of the formulated solution (containing 400 mg of verekitug \[UPB-101\]) and 0.5 mL of matching placebo subcutaneously in two separate injections every 24 weeks up to Week 96. Participants will also receive 2.0 mL and 0.5 mL of matching placebo subcutaneously in two separate injections at Weeks 12, 36, 60 and 84 visits.
PlaceboPLACEBO_COMPARATORParticipants will receive 0.5 mL of matching placebo and 2.0 mL of matching placebo subcutaneously in two separate injections every 12 weeks up to Week 96.
Verekitug 100 mg Q12W and PlaceboEXPERIMENTALParticipants will receive 0.5 mL of verekitug (100 mg) and 2.0 mL of matching placebo, subcutaneous (SC) injections, every 12 weeks (Q12W) for up to 48 weeks.
Verekitug 400 mg Q24W and PlaceboEXPERIMENTALParticipants will receive 2.0 mL of verekitug (400 mg) and 0.5 mL of matching placebo, SC injections, at Weeks 24 and 48 visits. Participants will also receive 2.0 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits.
Verekitug (UPB-101): 100 mg Q12W / PlaceboEXPERIMENTALParticipants will receive 0.5 milliliter (mL) of verekitug (UPB-101) formulated solution (containing 100 milligrams \[mg\] of verekitug \[UPB-101\]) and 2.0 mL of placebo subcutaneously in two separate injections every 12 weeks up to Week 48.
Verekitug (UPB-101): 400 mg Q24W / PlaceboEXPERIMENTALParticipants will receive 2.0 mL of verekitug (UPB-101) formulated solution (containing 400 mg of verekitug \[UPB-101\]) and 0.5 mL of placebo subcutaneously in two separate injections every 24 weeks up to Week 48. Participants will also receive 2 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits.
Verekitug (UPB-101): 100 mg Q24W / PlaceboEXPERIMENTALParticipants will receive 0.5 mL of verekitug (UPB-101) formulated solution (containing 100 mg of verekitug \[UPB-101\]) and 2.0 mL of placebo subcutaneously in two separate injections every 24 weeks up to Week 48. Participants will also receive 2 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits.
Verekitug (UPB-101)EXPERIMENTALParticipants will be administered 0.5 milliliter (mL) of verekitug (UPB-101) formulated solution (containing 100 milligrams \[mg\] of verekitug \[UPB-101\]) subcutaneously, every 12 weeks for 24 weeks.
Matching placeboPLACEBO_COMPARATORParticipants will be administered verekitug (UPB-101) matching placebo solution, subcutaneously, every 12 weeks for 24 weeks.
Active substance 1EXPERIMENTALUPB-101 Cohort 1
Active substance 2EXPERIMENTALUPB-101 Cohort 2
Active substance 3EXPERIMENTALUPB-101 Cohort 3
Active Substance 4EXPERIMENTALUPB-101 Cohort 4

Interventions

NameTypeDescription
VerekitugDRUGVerekitug (UPB-101) formulated solution
PlaceboOTHERMatching Placebo to Verekitug (UPB-101)
Verekitug (UPB-101)DRUGVerekitug (UPB-101) formulated solution
UPB-101DRUGSubcutaneous injection
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Eligibility Criteria

Age Range40 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites242

Inclusion Criteria: * Physician diagnosis of COPD for \>12 months. * Current or former smokers with a smoking history of 10 pack-years or more. * Post-bronchodilator FEV1/ Forced Vital Capacity (FVC) ratio \<0.70 and predicted post-bronchodilator FEV1 \>30% and ≤80%. * Modified Medical Research Cou...

Countries:United StatesArgentinaBulgariaChileCzechiaGeorgiaGermanyHungaryIndiaIrelandLatviaLithuaniaMalaysiaPhilippinesPolandRomaniaSerbiaSlovakiaSouth KoreaSpainTaiwanUkraineUnited KingdomCanadaItalyJapanSouth Africa
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Recent Changes (Last 90 Days)

MEDIUMOct 19, 2026NCT06164704TRIAL_REMOVED: changed

Frequently asked questions about UPB-101

What is UPB-101?

UPB-101 is an investigational small molecule being developed by Upstream Bio, Inc. for the treatment of asthma, a respiratory condition. It is in Phase 1 clinical development and has been studied in a completed early-stage trial. It is not an approved therapy.

What is UPB-101 used for in asthma?

UPB-101 is being studied as a treatment for asthma. Its only recorded clinical trial enrolled 32 adults with asthma in the United Kingdom to evaluate safety and biologic impact after repeated injections at increasing amounts. The drug remains investigational and is not approved for asthma or any other indication.

Who makes UPB-101?

UPB-101 is developed by Upstream Bio, Inc., which trades under the ticker UPB. The company is the sponsor of the Phase 1 asthma program for this small molecule candidate.

What phase is UPB-101 in?

UPB-101 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The program has tested the drug in 32 enrolled participants, all adults with asthma, in a randomized, double-blind, controlled study.

What clinical trials is UPB-101 in?

UPB-101 has been evaluated in one completed Phase 1 trial, NCT05448651, titled Safety and Biologic Impact (Pharmacodynamics) of Repeated Injections and Increasing Amounts of UPB-101 in Asthmatics. The trial enrolled 32 adults with asthma in the United Kingdom and used a randomized, double-blind, controlled design with biomarker selection.