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Revefenacin

Phase 4FDA approved

COPD | Small Molecules | Respiratory |Theravance Biopharma, Inc.|Trials Updated: Aug 13, 2025

Revefenacin development status

FDA approval on record Nov 9, 2018 as Yupelri
Approval holderMylan Ireland Ltd
ApplicationNDA210598
Highest phase Phase 4 (NCT05165485)
Phase scored for TBPHPhase 2
Registered trials 4 across 3 sponsors since Mar 2017

Label indication YUPELRI is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). YUPELRI is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) . FDA label

Revefenacin target and mechanism

Molecular targetCHRM3
Target classAntagonist
ModalitySmall Molecules

Also known as Revefenacin Inhalation Solution [Yupelri]

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Revefenacin clinical trials

Revefenacin · 1 trial · 2 indications

Phase 2 1
NCT04315558Revefenacin in Acute Respiratory Insufficiency in COPDCOPD
COMPLETED21 Analytics
PHASE2COMPLETED
Revefenacin in Acute Respiratory Insufficiency in COPD
COPDUnlock trial analytics

Study Endpoints

Primary Endpoints

Reduction in total inspiratory resistance Rstat at the time of drug trough
7 days

Reduction in total inspiratory resistance across the airways and ventilator circuit measured by the change in Static Resistance (Rstat) at the time of drug trough

Secondary Endpoints

Reduction in total inspiratory resistance Rdyn at the time of drug trough
7 days
Reduction in Resistive pressure (Pres) at the time of drug trough
7 days
Reduction in total inspiratory resistance Rstat at the time of drug peak
7 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RevefenacinEXPERIMENTALRevefenacin will be delivered once daily via nebulizer. In order to allow for full blinding and steady Q6 hours regimen in control arm, at hours 6, 12 and 18 after the Revefenacin dose, nebulized normal saline will be delivered.
IpratropiumACTIVE_COMPARATORNebulized ipratropium will be delivered via nebulizer Q6 hours.

Interventions

NameTypeDescription
Revefenacin Inhalation Solution [Yupelri]DRUGnebulized drug comparison
Ipratropium BromideDRUGnebulized drug comparison
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Adults ≥ 40 years of age * Acute respiratory failure requiring invasive mechanical ventilation * Documented history of COPD based on spirometric evidence of FEV1/FVC\<70% * Smoking history \>10 years (current or prior) * Invasive mechanical ventilation for \< 96 hours Exclusi...

Countries:United States
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Frequently asked questions about Revefenacin

What is revefenacin?

Revefenacin is an investigational small molecule developed by Theravance Biopharma, Inc. (TBPH) for COPD. It is also known as Revefenacin Inhalation Solution [Yupelri]. It is being studied in a Phase 2 clinical program for respiratory disease, including a completed trial in COPD with acute respiratory insufficiency.

What is revefenacin used for in COPD?

Revefenacin is being studied for COPD, including COPD with acute respiratory insufficiency. The Phase 2 trial NCT04315558 evaluated revefenacin in adults aged 40 years and older with COPD and acute respiratory failure. It is an investigational agent and is not established as a treatment outside of clinical research.

What does revefenacin target?

Revefenacin targets CHRM3, the M3 muscarinic acetylcholine receptor, and acts as an antagonist at this receptor. By blocking CHRM3, revefenacin is designed to interfere with cholinergic signaling in the airways, a mechanism relevant to respiratory conditions such as COPD.

Who makes revefenacin?

Revefenacin is developed by Theravance Biopharma, Inc., which trades under the ticker TBPH. The company is the sponsor of the clinical program studying revefenacin in COPD and related respiratory conditions.

What phase is revefenacin in?

Revefenacin is in Phase 2 development for COPD. It is an investigational drug and is not approved by the FDA for this use. The Phase 2 program includes one completed trial, and no active trials are currently listed for revefenacin.

What clinical trials is revefenacin in?

Revefenacin has been studied in the Phase 2 trial NCT04315558, titled Revefenacin in Acute Respiratory Insufficiency in COPD. The trial was completed, enrolled 21 participants, was randomized, double blind, and active controlled, and was conducted in the United States in adults aged 40 years and older.

Is revefenacin the same as Revefenacin Inhalation Solution [Yupelri]?

Yes, revefenacin is also known as Revefenacin Inhalation Solution [Yupelri]. Both names refer to the same small molecule developed by Theravance Biopharma, Inc. (TBPH) and studied in COPD. Readers searching either name will find the same drug asset.