Last Updated: May 12, 2026

CLINICAL TRIALS PROFILE FOR PERCODAN


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All Clinical Trials for PERCODAN

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00771758 ↗ Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis Completed Grünenthal GmbH Phase 3 2008-09-01 The purpose of this study is to determine the effectiveness and safety of tapentadol immediate release (IR) as compared with placebo and oxycodone IR in patients with acute pain caused by vertebral compression fractures (VCF) associated with assumed osteoporosis for whom treatment with oral opioid analgesics is appropriate.
NCT00771758 ↗ Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis Completed Ortho-McNeil Janssen Scientific Affairs, LLC Phase 3 2008-09-01 The purpose of this study is to determine the effectiveness and safety of tapentadol immediate release (IR) as compared with placebo and oxycodone IR in patients with acute pain caused by vertebral compression fractures (VCF) associated with assumed osteoporosis for whom treatment with oral opioid analgesics is appropriate.
NCT04752384 ↗ Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients Recruiting Medical College of Wisconsin Phase 2 2021-07-08 This is a single-arm prospective clinical trial to determine the safety and feasibility of using transdermal buprenorphine in alleviation of radiation induced mucositis pain in head and neck cancer patients.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PERCODAN

Condition Name

Condition Name for PERCODAN
Intervention Trials
Back Pain 1
Head and Neck Squamous Cell Carcinoma 1
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Condition MeSH

Condition MeSH for PERCODAN
Intervention Trials
Head and Neck Neoplasms 1
Osteoporosis 1
Fractures, Compression 1
Back Pain 1
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Clinical Trial Locations for PERCODAN

Trials by Country

Trials by Country for PERCODAN
Location Trials
United States 16
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Trials by US State

Trials by US State for PERCODAN
Location Trials
Wisconsin 1
Texas 1
South Carolina 1
Oregon 1
Ohio 1
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Clinical Trial Progress for PERCODAN

Clinical Trial Phase

Clinical Trial Phase for PERCODAN
Clinical Trial Phase Trials
Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for PERCODAN
Clinical Trial Phase Trials
Completed 1
Recruiting 1
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Clinical Trial Sponsors for PERCODAN

Sponsor Name

Sponsor Name for PERCODAN
Sponsor Trials
Grünenthal GmbH 1
Ortho-McNeil Janssen Scientific Affairs, LLC 1
Medical College of Wisconsin 1
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Sponsor Type

Sponsor Type for PERCODAN
Sponsor Trials
Industry 2
Other 1
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PERCODAN Market Analysis and Financial Projection

Last updated: April 25, 2026

PERCODAN: Clinical Trial Update, Market Analysis, and Projection

PERCODAN is an older oral opioid analgesic product (oxycodone hydrochloride plus aspirin). No current, publicly verifiable clinical development program with active interventional trials under the same brand name was identified from authoritative trial registries in the post-approval era. The market profile is therefore driven by the age of the product, loss of exclusivity dynamics in most jurisdictions, ongoing generic competition, and regulatory actions affecting opioid prescribing rather than by new branded late-stage development.


Is PERCODAN under active clinical development right now?

Public clinical trial activity for “PERCODAN” specifically is minimal and not consistently indexed under that brand name in major registries. In practice, opioid combinations like oxycodone/aspirin show trial activity more commonly under generic or ingredient-based descriptors (oxycodone plus aspirin) rather than the brand name.

What is observable from trial-ecosystem reality

  • The drug is not widely associated with current, brand-indexed Phase 3 or pivotal studies in public registries.
  • New clinical work in this therapeutic area typically targets modified-release oxycodone, abuse-deterrent formulations, or different analgesic combinations, not an older ox ycodone plus aspirin fixed-dose brand.

Implication for an investor or R&D planner

  • For PERCODAN, “clinical trials update” is effectively a status update: there is no meaningful near-term pipeline risk-adjusted upside from fresh pivotal data tied to the brand name.

What is PERCODAN’s market structure today?

PERCODAN is a combination opioid analgesic with aspirin. In most developed markets:

  • The branded product is structurally exposed to extensive generic penetration once patent exclusivity has expired.
  • The total addressable market for opioid analgesics is constrained by:
    • prescribing guidelines,
    • payer utilization management,
    • and regulatory scrutiny focused on opioid safety and misuse.

Core market drivers

  1. Therapeutic substitution
    • Clinicians can switch to other opioid analgesics (including acetaminophen-opioid and pure opioid options), and to non-opioid multimodal regimens.
  2. Safety and utilization controls
    • Opioid risk mitigation programs and prescribing restrictions reduce broad access, particularly for chronic non-cancer pain.
  3. Formulation drift
    • Industry shifts toward abuse-deterrent and modified-release products, changing share away from older immediate-release combinations.

Competitive set (real-world substitution)

  • Other oral opioid combinations (oxycodone-containing products with different non-NSAID co-ingredients)
  • Pure oxycodone products in immediate and modified-release forms
  • Non-opioid analgesics and adjuvant regimens (where formularies restrict opioids)

Where does PERCODAN still fit in formularies and prescribing?

PERCODAN’s residual use is typically limited to scenarios where:

  • prescriber choice still favors oxycodone plus aspirin combinations, or
  • a generic oxycodone/aspirin product is selected under formulary economics.

But fixed-dose aspirin combinations face distinct barriers

  • Aspirin-related contraindications and intolerance
  • Bleeding risk considerations
  • Use restrictions in certain patient populations where NSAIDs or aspirin are disfavored

Net: PERCODAN’s practical market is not “growing branded demand.” It is a fragmented, generic-led segment with declining share potential under opioid stewardship trends.


How should the market be projected (base, upside, downside)?

Projection framework

Because PERCODAN is an older, mostly generic-exposed opioid combination, a projection must model:

  • generic and payer channel dynamics,
  • prescribing compression for opioids,
  • and low likelihood of brand re-acceleration absent new pivotal evidence.

Below is a directional projection suitable for internal planning. It uses scenario logic rather than asserting a single point estimate without recoverable brand-level sales datasets.

Base case (most likely)

  • Demand stays stable to down modestly as opioid prescribing continues to tighten and prescribers favor alternatives.
  • Share migrates toward other oxycodone formulations and combination products.
  • Price erosion persists in line with generic norms.

Outcome

  • A slow decline in net revenue in nominal terms, and a faster decline in volume.

Downside case

  • Tighter opioid prescribing enforcement, additional payer restrictions, and continued substitution accelerate decline.
  • Aspirin-combination constraints worsen relative to safer co-ingredient options (e.g., acetaminophen-based combos).

Outcome

  • Faster volume contraction and steeper net revenue decline.

Upside case

  • A payer-level shift toward low-cost generic opioid combinations supports short-term stability.
  • Limited competitor displacement for the specific oxycodone/aspirin mix.

Outcome

  • Near-term stabilization with modest price compression but less volume erosion.

What are the key regulatory and safety factors impacting commercial outlook?

Opioid medicines face persistent scrutiny and control in multiple jurisdictions. These dynamics tend to reduce utilization growth and can create abrupt formulary headwinds.

Mechanisms that typically affect market trajectory

  • tighter prescribing guidelines for chronic pain
  • payer prior authorization or step therapy
  • risk evaluation and mitigation measures
  • label risk changes over time

For a fixed-dose opioid combination with aspirin, additional clinical caution can reduce adoption in populations where aspirin is contraindicated.


What does this mean for R&D investment decisions?

If the question is whether PERCODAN can be “repositioned” through clinical development:

  • The brand itself is not supported by a visible pipeline in public registries under the brand label.
  • The economics of re-launch typically require a differentiated formulation (for abuse deterrence or safety improvements) or a new indication with a demonstrable evidence package.
  • Without that, PERCODAN behaves like a commodity segment under opioid policy pressure.

Actionable conclusion for business planning

  • Treat PERCODAN as a managed portfolio asset in a constrained opioid segment rather than a platform for near-term growth.
  • If a developer wants growth exposure in oxycodone analgesics, the investment case usually shifts toward modern formulations rather than the older oxycodone/aspirin combination.

Key Takeaways

  • PERCODAN (oxycodone hydrochloride plus aspirin) is not showing a clear, brand-indexed active pivotal clinical development footprint in public registries in the post-approval era; the market outcome is governed by generic competition and opioid prescribing controls rather than new clinical upside.
  • The commercial environment for opioids is structurally constrained by guideline and payer utilization management, pushing substitution toward other opioid options and multimodal non-opioid regimens.
  • Market projection should be scenario-based with base case showing slow erosion of volume and net revenue, downside reflecting further prescribing tightening, and limited upside tied to generic low-cost retention rather than demand expansion.

FAQs

1. Is there a current Phase 3 program for PERCODAN under that brand name?

No clear brand-indexed Phase 3 activity is apparent from public trial registry patterns for PERCODAN itself.

2. What is the main competitive pressure on PERCODAN?

Generic oxycodone combination products plus substitution to other opioid formulations and non-opioid regimens under formulary controls.

3. How do opioid stewardship policies affect PERCODAN pricing and volume?

They reduce prescribing and increase utilization management, which typically accelerates volume contraction and supports continued price erosion in a generic-driven segment.

4. Does aspirin in the combination limit adoption?

Yes. Aspirin introduces bleeding risk and contraindication considerations that can reduce use versus combinations with different co-ingredients.

5. What kind of development would be required to create brand-level upside?

A new differentiated formulation or evidence package that meaningfully changes safety, abuse deterrence, or indication positioning, rather than incremental use of the existing fixed-dose combination.


References (APA)

  1. U.S. Food and Drug Administration. (n.d.). Drug approvals and related information. https://www.fda.gov/drugs
  2. ClinicalTrials.gov. (n.d.). Search results for PERCODAN and related oxycodone/aspirin terms. https://clinicaltrials.gov
  3. World Health Organization. (n.d.). Opioids and public health guidance resources. https://www.who.int/health-topics/opioids

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