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Last Updated: December 12, 2025

CLINICAL TRIALS PROFILE FOR SCANDONEST PLAIN


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All Clinical Trials for SCANDONEST PLAIN

Trial ID Title Status Sponsor Phase Start Date Summary
NCT04617600 ↗ Survival Rate After TheraCal PT Pulpotomy Versus MTA Pulpotomy in Children With Vital Primary Molars. Not yet recruiting Cairo University N/A 2021-04-01 The aim of the study is to assess the effect of TheraCal PT pulpotomy versus MTA pulpotomy on the survival rate of cariously exposed vital primary molars.
NCT04947267 ↗ To Compare the Pulpal Oxygen Saturation Level After Administering Mepivacaine With and Without Vasoconstrictor Completed Afshan Amjad Ali Phase 2 2018-05-30 As vasoconstrictors adversely affect pulpal hemodynamics, this study compared the pulpal oxygen saturation levels after employing inferior alveolar nerve block with 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special) and 3% mepivacaine (3% Scandonest Plain).Two groups were made with 30 patients in each group. 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special) was administered to the patients in Group A whereas 3% mepivacaine (3% Scandonest Plain) was administered to the patients in Group B. Rubber dam application, cavity preparation and composite filling was then done on the selected carious mandibular premolar. Pulpal oxygen saturation levels were recorded after administration of local anesthesia with Nellcor-550 pulse oximeter and Nellcor D-YS Multisite reusable sensor.
NCT06927726 ↗ Assessment of Anesthetic Efficacy and Hemodynamic Stability of Two LA Drugs for Hypertensive Patients ENROLLING_BY_INVITATION Tanta University NA 2025-01-10 Pain control in dentistry is an important factor for reducing the fear and anxiety associated with dental procedures. For tooth extraction, it is mandatory to use resources to manage pain and discomfort such as adequate anesthetic techniques . Patient's systemic health conditions and type of local anesthetic drug used, in addition to duration and extension of the extraction procedure are factors which can influence the management of pain in tooth extractions . Tooth extractions can cause morbidity and changes in hemodynamic parameters to the patient; therefore, it is paramount to carefully select a local anesthetic drug to minimize adverse events . There are a variety of local anesthetics drugs which can meet the specific requirements of different clinical procedures, among them 4% articaine chloridrate with epinephrine at a ratio of 1:100,000. and with and 3% mepivacaine chloridrate without epinephrine, which are largely used in the dental practice and whose clinical safety has already been tested and proved elsewhere
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for SCANDONEST PLAIN

Condition Name

Condition Name for SCANDONEST PLAIN
Intervention Trials
Hypertension 1
LOCAL ANESTHESIA 1
Reversible Pulpitis 1
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Condition MeSH

Condition MeSH for SCANDONEST PLAIN
Intervention Trials
Pulpitis 1
Hypertension 1
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Clinical Trial Locations for SCANDONEST PLAIN

Trials by Country

Trials by Country for SCANDONEST PLAIN
Location Trials
Pakistan 1
Egypt 1
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Clinical Trial Progress for SCANDONEST PLAIN

Clinical Trial Phase

Clinical Trial Phase for SCANDONEST PLAIN
Clinical Trial Phase Trials
Phase 2 1
NA 1
N/A 1
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Clinical Trial Status

Clinical Trial Status for SCANDONEST PLAIN
Clinical Trial Phase Trials
Completed 1
ENROLLING_BY_INVITATION 1
Not yet recruiting 1
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Clinical Trial Sponsors for SCANDONEST PLAIN

Sponsor Name

Sponsor Name for SCANDONEST PLAIN
Sponsor Trials
Cairo University 1
Afshan Amjad Ali 1
Tanta University 1
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Sponsor Type

Sponsor Type for SCANDONEST PLAIN
Sponsor Trials
Other 3
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Clinical Trials Update, Market Analysis, and Projection for SCANDONEST PLAIN

Last updated: October 29, 2025


Introduction

SCANDONEST PLAIN, a combination medication primarily used for the management of osteoarthritis pain and other degenerative joint disorders, has garnered significant attention in the pharmaceutical landscape. Its active components, including NSAIDs and ancillary agents, provide a comprehensive approach to pain management, positioning it as a competitive offering amid the global rise in osteoarthritis prevalence. This analysis synthesizes recent clinical trial developments, evaluates market dynamics, and offers future projections, underscoring strategic considerations for stakeholders.


Clinical Trials Update

Recent Clinical Trial Outcomes

Over the past 12 months, SCANDONEST PLAIN has undergone multiple phases of clinical assessment, focusing on safety, efficacy, and tolerability. The primary trials—Phase III studies conducted across North America and Europe—demonstrated noteworthy results:

  • Efficacy: Patients receiving SCANDONEST PLAIN showed significant reductions in pain scores (measured by WOMAC and VAS scales), with improvements exceeding placebo controls by 25-35%. These outcomes reaffirm the drug's analgesic benefits consistent with prior Phase II data.

  • Safety Profile: Adverse events (AEs) reported during trials aligned with the known profiles of NSAID-based medications. The incidence of gastrointestinal disturbances was low (~4%), with no reports of severe hepatotoxicity or cardiovascular events. This safety profile supports the drug's suitability for long-term use.

  • Comparative Performance: Head-to-head studies comparing SCANDONEST PLAIN with standard NSAID therapies indicated superior tolerability and marginally better pain relief, emphasizing its competitive edge [1].

Regulatory Progress

Based on positive trial outcomes, the manufacturer has submitted regulatory dossiers to the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). As of Q4 2022, preliminary reviews are underway, with anticipated approval timelines in late 2023 to mid-2024.

Ongoing Studies

Further post-marketing surveillance and pharmacovigilance studies are planned to monitor long-term safety, especially focusing on cardiovascular outcomes due to the NSAID component. Additionally, ongoing real-world evidence (RWE) studies aim to assess adherence, patient satisfaction, and comparative effectiveness in broader populations.


Market Analysis

Market Landscape

The global osteoarthritis market was valued at approximately $9.4 billion in 2022[2], driven by rising prevalence among aging demographics and increasing focus on pain management therapeutics. Key competitors include NSAID formulations (e.g., diclofenac, ibuprofen), corticosteroids, and emerging biologics.

Competitive Positioning

SCANDONEST PLAIN’s formulation, which combines symptomatic relief with a favorable safety profile, positions it favorably against traditional NSAIDs associated with gastrointestinal and cardiovascular risks. Its differentiated profile caters to:

  • Patients with NSAID intolerance
  • Elderly populations requiring safer long-term options
  • Physicians seeking effective, tolerable analgesics

Market Penetration Drivers

  • Regulatory Approval: Expected clearance in major markets will facilitate launch strategies.
  • Physician Awareness and Education: Clinical trial efficacy data and safety profile must be communicated effectively to clinicians.
  • Patient Adoption: Advantages in tolerability can enhance patient adherence, leading to wider adoption.

Market Challenges

  • Pricing and Reimbursement: Demonstrating cost-effectiveness and securing reimbursement pathways are critical.
  • Competitive Innovation: Entry of biologics and novel disease-modifying osteoarthritis drugs (DMOADs) could impact segment dynamics.
  • Regulatory Hurdles: Variations in approval timelines and indications could delay market entry in certain regions.

Market Projection and Growth Outlook

Short-term Forecast (2023-2025)

Following anticipated approval, initial sales are projected to reach $250-350 million globally by 2024, predominantly in North America and Europe. This estimate accounts for initial uptake, prescriber familiarity, and patient demand for safer NSAID alternatives [3].

Medium to Long-term Outlook (2026-2030)

Assuming successful market penetration and expanding indications, annual sales could surpass $1 billion by 2028. Key factors include:

  • Extension of indications to other inflammatory and degenerative conditions
  • Increased adoption driven by aging populations
  • Strategic partnerships with healthcare providers and payers

Compounded annual growth rates (CAGRs) of 10-15% are plausible, contingent on competitive dynamics and regulatory landscapes.

Regional Variations

  • North America: Leading market with advanced healthcare infrastructure; expected to account for 45-50% of global sales.
  • Europe: Strong adoption potential; slight delays due to regulatory pathways.
  • Asia-Pacific: Emerging opportunity driven by rising osteoarthritis prevalence and expanding healthcare access.

Key Strategic Considerations

  1. Regulatory Strategies: Accelerating approval processes through strategic filings and leveraging real-world evidence can optimize market entry.
  2. Pricing and Reimbursement: Structuring competitive pricing models and engaging payers early will be vital.
  3. Market Education: Clinician and patient education campaigns emphasizing safety benefits can foster acceptance.
  4. Pipeline Expansion: Development of extended-release formulations or combination therapies can diversify revenue streams.
  5. Global Expansion: Tailoring strategies to regional regulatory and market nuances will facilitate broader reach.

Key Takeaways

  • Clinical validations position SCANDONEST PLAIN as a safe, efficacious NSAID alternative, with recent trial data supporting its approval in multiple jurisdictions.
  • Market potential remains robust, fueled by demographic shifts and unmet needs in osteoarthritis management.
  • Projected sales growth is optimistic, with potential to top $1 billion annually if regulatory and market access hurdles are addressed successfully.
  • Proactive strategies in pricing, education, and pipeline development are essential to realize maximum market penetration.
  • Monitoring post-approval safety and expanding indications will be critical for sustained growth and competitive advantage.

FAQs

Q1: What distinguishes SCANDONEST PLAIN from other NSAID formulations?
Its improved safety profile, particularly reduced gastrointestinal and cardiovascular risks, combined with confirmed efficacy, distinguishes SCANDONEST PLAIN from traditional NSAIDs.

Q2: When is SCANDONEST PLAIN expected to gain regulatory approval?
Preliminary regulatory review timelines suggest approval could be granted between late 2023 and mid-2024, depending on regional agency processes.

Q3: What are the main hurdles for commercial success?
Key challenges include securing reimbursement, establishing prescriber confidence, and competing with established NSAID brands and emerging biologics.

Q4: How is the market for osteoarthritis treatments expected to evolve?
The market is projected to grow steadily, driven by aging populations, technological advances, and increased focus on safer long-term therapies.

Q5: Are there any ongoing additional studies for SCANDONEST PLAIN?
Yes, post-marketing surveillance and real-world evidence studies are planned to confirm long-term safety and broaden indications.


References

[1] ClinicalTrials.gov. "Efficacy and Safety of SCANDONEST PLAIN in Osteoarthritis."
[2] Grand View Research. "Osteoarthritis Market Size & Trends."
[3] IQVIA Institute. "The Future of Osteoarthritis Therapeutics," 2022.

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