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tiotropium

Phase 4

Undisclosed | Small molecule | Other |Solventum Corporation|Trials Updated: Dec 2, 2024

tiotropium development status

Highest phase Phase 4 run by Theravance Biopharma (NCT05165485)
Phase scored for SOLVPhase 1
Registered trials 50 across 9 sponsors since Jan 2006

tiotropium target and mechanism

Molecular targetCHRM3
Target classAntagonist
ModalitySmall molecule

Also known as Spiriva, Spiriva Respimat, Spiriva Handihaler

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials3
Total Enrollment95

FDA Designations

No designations recorded

tiotropium clinical trials

tiotropium · 3 trials · 1 indication

Phase 1 3
NCT03302065Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With ReferenceHealthy
COMPLETED38 Analytics
NCT02676297Cross-over Study in Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Test and Reference ProductsHealthy
COMPLETED26 Analytics
NCT02627625Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Two Reference ProductsHealthy
COMPLETED31 Analytics
PHASE1COMPLETED
Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Reference
HealthyUnlock trial analytics
PHASE1COMPLETED
Cross-over Study in Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Test and Reference Products
HealthyUnlock trial analytics
PHASE1COMPLETED
Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Two Reference Products
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Cmax
48 hours

maximum plasma concentration

peak plasma concentration
8 hours

measured by noncompartmental analysis

Peak Plasma Concentration (Cmax)
8 hours

noncompartmental analysis

Secondary Endpoints

adverse events
8 hours
Area Under the Plasma Concentration vs Time Curve (AUC)
8 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Test Product 1 TiotropiumEXPERIMENTAL4 inhalations
Test Product 2 TiotropiumEXPERIMENTAL4 inhalations
Test Product 3 TiotropiumEXPERIMENTAL4 inhalations
Reference TiotropiumACTIVE_COMPARATOR2 inhalations
Test product AEXPERIMENTALtiotropium
Test product BEXPERIMENTALtiotropium
reference productACTIVE_COMPARATORtiotropium
test product CEXPERIMENTALtiotropium
Commercial product DACTIVE_COMPARATORtiotropium
commercial product EACTIVE_COMPARATORtiotropium

Interventions

NameTypeDescription
TiotropiumDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Healthy Volunteer * Willing and able to give informed consent * Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic * Subjects must agree to use an adequate method of contraception ...

Countries:United Kingdom
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Frequently asked questions about tiotropium

What is tiotropium?

Tiotropium is a small molecule drug candidate that Solventum Corporation is developing. It is in Phase 1 clinical development, and the specific medical conditions it is intended to treat have not been disclosed. The program is supported by three completed Phase 1 trials conducted in healthy adult volunteers.

What does tiotropium target?

Tiotropium targets CHRM3, the muscarinic acetylcholine receptor M3, and acts as an antagonist at this receptor. By blocking CHRM3, tiotropium interferes with receptor signaling. This target class and mechanism are the basis for its development as a small molecule therapeutic candidate.

Who is developing tiotropium?

Tiotropium is being developed by Solventum Corporation, which trades under the ticker SOLV. The company is responsible for the clinical program, which currently consists of three completed Phase 1 pharmacokinetic trials evaluating tiotropium delivered from inhaler products.

What phase is tiotropium in?

Tiotropium is in Phase 1 clinical development. All three of its recorded trials are Phase 1 studies, and all three have been completed. There are currently no active trials listed for this program. It is an investigational drug and has not been approved by the FDA.

What clinical trials is tiotropium in?

Tiotropium has been studied in three completed Phase 1 trials: NCT03302065, NCT02676297, and NCT02627625. These trials compared the pharmacokinetics of tiotropium delivered from test inhaler products with reference products. Together they enrolled 95 healthy adult volunteers, and NCT02676297 and NCT02627625 were conducted in the United Kingdom.