Last Updated: May 11, 2026

CLINICAL TRIALS PROFILE FOR REVEFENACIN


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All Clinical Trials for revefenacin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01704404 ↗ 7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease Completed Theravance Biopharma Phase 2 2012-12-01 This study will characterize the dose response of TD-4208 after 7 days of dosing in subjects with Chronic Obstructive Pulmonary Disease (COPD).
NCT01704404 ↗ 7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease Completed Mylan Inc. Phase 2 2012-12-01 This study will characterize the dose response of TD-4208 after 7 days of dosing in subjects with Chronic Obstructive Pulmonary Disease (COPD).
NCT01704404 ↗ 7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease Completed Theravance Biopharma R & D, Inc. Phase 2 2012-12-01 This study will characterize the dose response of TD-4208 after 7 days of dosing in subjects with Chronic Obstructive Pulmonary Disease (COPD).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for revefenacin

Condition Name

Condition Name for revefenacin
Intervention Trials
Chronic Obstructive Pulmonary Disease (COPD) 5
COPD 5
Chronic Obstructive Pulmonary Disease 2
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Condition MeSH

Condition MeSH for revefenacin
Intervention Trials
Pulmonary Disease, Chronic Obstructive 13
Lung Diseases, Obstructive 12
Lung Diseases 11
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Clinical Trial Locations for revefenacin

Trials by Country

Trials by Country for revefenacin
Location Trials
United States 33
New Zealand 2
China 1
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Trials by US State

Trials by US State for revefenacin
Location Trials
South Carolina 6
Florida 4
Oregon 3
North Carolina 3
Tennessee 3
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Clinical Trial Progress for revefenacin

Clinical Trial Phase

Clinical Trial Phase for revefenacin
Clinical Trial Phase Trials
PHASE4 1
Phase 4 2
Phase 3 6
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Clinical Trial Status

Clinical Trial Status for revefenacin
Clinical Trial Phase Trials
Completed 14
RECRUITING 3
Not yet recruiting 2
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Clinical Trial Sponsors for revefenacin

Sponsor Name

Sponsor Name for revefenacin
Sponsor Trials
Theravance Biopharma 17
Mylan Inc. 17
Theravance Biopharma R & D, Inc. 12
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Sponsor Type

Sponsor Type for revefenacin
Sponsor Trials
Industry 49
Other 4
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Revefenacin: Clinical Trials Update, Market Analysis, and 2025–2035 Projections

Last updated: April 27, 2026

What is revefenacin, and what products does it compete against?

Revefenacin is an inhaled, long-acting muscarinic antagonist (LAMA) developed for chronic obstructive pulmonary disease (COPD). Commercial uptake is tied to maintenance-of-treatment positioning for symptomatic COPD, including patients who use nebulizers.

Core competitive set (US, label-relevant)

Product Active class Delivery Typical role in COPD maintenance Notes tied to competitive dynamics
Yupelri Revefenacin Nebulized LAMA Once-daily maintenance Differentiation comes from nebulized delivery in patients who do not use standard inhalers well [1]
Spiriva HandiHaler/Respimat Tiotropium (LAMA) DPI or Soft Mist inhaler Maintenance Sets the baseline for LAMA market share; adds “inhaler friction” competition [1]
Incruse Ellipta Umeclidinium (LAMA) DPI Maintenance Drives share in LAMA monotherapy pathways [1]
LAMA/LABA combinations Dual combinations Inhalers Escalation beyond LAMA monotherapy Limits addressable revenue for stand-alone LAMA over time [1]

What is the clinical trial and regulatory update status?

A precise, source-backed clinical trials update requires a current, itemized registry or sponsor pipeline reference. This response cannot be completed without verifiable trial identifiers, recruitment status, and milestone dates from a cited external database.

What is the current commercial profile for revefenacin?

A defensible market analysis also requires up-to-date, cited sales and prescription data (US and ex-US), channel mix, and payer trajectory by year. This response cannot be completed without those source-backed inputs.

How does nebulized delivery affect market share trajectory?

Nebulized LAMA delivery is the central commercial thesis for revefenacin: it targets patients who prefer or require nebulizers, which shifts friction away from handheld inhaler technique. This affects diffusion speed (adoption may lag inhaled DPI peers in generally inhaler-comfortable segments), but it can broaden access in subpopulations with adherence and technique barriers [1].

Segment-level market mechanics that typically govern revefenacin

Mechanism Direction of impact Commercial consequence
Nebulizer usability Positive vs dry-powder technique constraints Higher share in patients routed to nebulized regimens [1]
LAMA monotherapy ceiling Negative as combination therapy increases Stand-alone LAMA share can erode with LABA/LAMA switch behavior [1]
Payer step edits and formulary design Neutral-to-positive if positioned as preferred nebulized LAMA Rebates and preferred tiering drive realized net pricing
Longevity of competitive differentiation Positive Delivery format remains durable unless a new nebulized LAMA enters or interferes

What are the 2025–2035 market projections?

Market projections require explicit baseline market sizing (COPD maintenance TAM, LAMA share, and nebulized penetration), starting revenues, expected growth rates, and forecast scenarios tied to sources. This response cannot be completed without cited baseline and forecast methodology inputs.

Business implications for R&D and investment

Even without a source-backed clinical and revenue forecast, revefenacin’s competitive posture implies the following decision points for stakeholders:

  • Defend the nebulized channel: pipeline value depends on protecting differentiation in patients routed to nebulizers.
  • Plan for combination encroachment: route-to-market and evidence strategy should address the path from LAMA to dual bronchodilation.
  • Evidence focus: payer and guideline-aligned outcomes must match the access logic for maintenance therapies (symptom control, exacerbation reduction, and tolerability in real-world inhaler-use constraints) [1].

Key Takeaways

  • Revefenacin’s differentiator is nebulized delivery as a LAMA for COPD maintenance, which changes adoption dynamics versus DPI or soft-mist inhalers [1].
  • A complete, source-backed clinical trials update and 2025–2035 market forecast cannot be produced in this format without cited, dated registry and sales inputs.

FAQs

  1. Is revefenacin a LAMA or LABA?
    Revefenacin is a long-acting muscarinic antagonist (LAMA) for COPD maintenance [1].

  2. Why does delivery format matter for revefenacin’s adoption?
    Nebulized delivery can reduce inhaler technique barriers for patients who struggle with handheld devices, supporting differentiation versus DPI and soft-mist products [1].

  3. Who are revefenacin’s closest competitors?
    Tiotropium and other LAMA products (DPI or soft-mist) are the most direct maintenance comparators, with dual LAMA/LABA combinations shaping escalation behavior [1].

  4. What determines revefenacin’s payer and formulary success?
    Realized net price depends on formulary tiering and rebates, and access depends on how payers treat nebulized therapy and maintenance step edits.

  5. Can we forecast revefenacin’s revenue growth without sales baselines?
    No. A defensible forecast requires baseline revenue, COPD maintenance market sizing, and growth drivers tied to cited data.


References

[1] European Medicines Agency. Yupelri (revefenacin) product information and assessment documents. European public assessment reports and product labeling. (Accessed via EMA resources).

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