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Last Updated: December 16, 2025

CLINICAL TRIALS PROFILE FOR AIR POLYMER-TYPE A


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505(b)(2) Clinical Trials for air polymer-type a

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT04026945 ↗ Sustained Release Lidocaine for Treatment of Scrotal Pain Completed University of British Columbia Phase 1/Phase 2 2019-10-31 In this study, the investigators are testing a new formulation of lidocaine for its suitability in managing chronic scrotal pain (CSCP). The new formulation ST-CP is a lidocaine sustained-release formulation and is expected to provide pain relief over 4 weeks. Currently, the drug lidocaine is not available as an injectable slow-release formulation and chronic scrotal pain patients are often left untreated.
New Formulation NCT05193227 ↗ Sustained Release Lidocaine for the Treatment of Postoperative Pain Recruiting University of British Columbia Phase 2 2021-10-27 In this study, the investigators are testing a new formulation of lidocaine for its suitability in managing postoperative pain after pelvic surgery. The new formulation ST-01 is a sustained release lidocaine formulation and is expected to provide pain relief over multiple days. Currently, the drug lidocaine is not available as an injectable slow-release formulation.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for air polymer-type a

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00003876 ↗ Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma Completed Barrett Cancer Center Phase 1 1999-04-01 RATIONALE: Internal radiation uses high-energy radiation to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining internal radiation therapy with chemotherapy implants may kill remaining tumor cells following surgery. PURPOSE: Phase I trial to study the effectiveness of internal radiation therapy plus carmustine implants in treating patients who have recurrent or refractory malignant glioma.
NCT00003878 ↗ Carmustine Implants in Treating Patients With Brain Metastases Completed National Cancer Institute (NCI) Phase 2 2002-04-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of implanted carmustine wafers in treating patients who have brain metastases and who are undergoing surgery to remove the tumor.
NCT00003878 ↗ Carmustine Implants in Treating Patients With Brain Metastases Completed New Approaches to Brain Tumor Therapy Consortium Phase 2 2002-04-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of implanted carmustine wafers in treating patients who have brain metastases and who are undergoing surgery to remove the tumor.
NCT00004315 ↗ Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease Unknown status Children's Hospital Medical Center, Cincinnati Phase 2 1995-11-01 OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease. II. Compare the differences in pruritus, weight gain, and liver function for both treatments.
NCT00004315 ↗ Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease Unknown status National Center for Research Resources (NCRR) Phase 2 1995-11-01 OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease. II. Compare the differences in pruritus, weight gain, and liver function for both treatments.
NCT00005783 ↗ A Phase I/II Trial of Recombinant-Methionyl Human Stem Cell Factor (SCF) in Adult Patients With Sickling Disorders Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 1 2000-03-01 Sickle cell anemia is a genetic disorder that results from a single nucleotide substitution in codon 6 of the beta-globin gene which, in the homozygous state, produces an abnormal hemoglobin that is prone to polymer formation when deoxygenated. The polymerized hemoglobin leads to impaired deformability and sickling of red blood cells which subsequently lodge in end-arterioles producing the classic and most prominent feature of the disorder, repeated vasoocclusive crises. Despite knowledge of the precise genetic defect for decades, only recently has there been therapeutic impact based upon this knowledge when a clear benefit from treatment with hydroxyurea, a cell cycle-specific agent administered to induce production of fetal hemoglobin (HbF) by stimulating gamma-globin synthesis, was reported in patients with sickle cell disease (SCD). The reduction in the frequency and severity of vasoocclusive crises seen has been attributed to the increase in HbF levels in responsive patients. While the majority of patients demonstrate a rise in HbF, not all such patients benefit from treatment. Given these results, alternative agents that also stimulate the production of HbF warrant investigation in the treatment of SCD. Recombinant-methionyl human stem cell factor (SCF) is a hematopoietic growth factor with activity on immature hematopoietic progenitor cells. SCF stimulates the production of HbF in vitro and in vivo, and this effect is attainable without the myelosuppression associated with hydroxyurea. In this phase I/II trial, we will administer SCF in a dose escalating fashion to patients with sickling disorders. Parameters to be measured are HbF levels, F cell levels, peripheral blood CD34 levels, frequency, duration, and severity of vasoocclusive crises, and toxicity.
NCT00063765 ↗ Evaluation of Safety of Ciliary Neurotrophic Factor Implants in the Eye Completed National Eye Institute (NEI) Phase 1 2003-06-01 This study will evaluate the safety of a ciliary neurotrophic factor (CNTF) implant placed in the eye to allow the release of CNTF directly on the retina. The results of this study may lead to a larger investigation of CNTF implants to treat retinitis pigmentosa (RP), a progressive degenerative eye disease that begins with loss of peripheral vision and night blindness and often leads to blindness in later life. Currently, there are no effective treatments for RP. Researchers have found, however, that certain proteins, called ciliary neurotrophic factor (CNTF), can partially protect cells in the eye if given directly inside the eye. A major challenge in treating RP is to deliver medicine directly into the eye. One way to ensure that CNTF gets into the eye is to surgically place an implant inside the eye to release the protein. Patients 18 years of age and older with retinitis pigmentosa whose visual acuity is 20/100 or worse may be eligible for this study. Candidates will be screened with a medical history, physical examination, eye examinations, and eye photographs. The eye examination includes measurement of visual acuity and eye pressure, examination of the pupils and eye movements, and examination of the lens and back of the eye. In addition, patients will have the following tests: - Visual field test: Patients look at a central spot on a white screen and tell the examiner whenever they see a small light appear at other places on the screen. - Electroretinogram (ERG): Electrodes are taped to the patient's forehead. Special contact lenses are placed on the eyes, similar to normal contact lenses, after the eye has been numbed with drops. The contact lenses sense small electrical signals generated by the retina. The ERG measures the electrical activity of the retina when it is stimulated by light. For the ERG recording, the patient looks inside a large, hollow, dark sphere, and sees flashes of light, first in the dark, and then with a light turned on in the sphere. - Optical coherence tomography: This test, done with the machine used to examine the eye, measures retinal thickness by producing cross-sectional pictures of the retina. Participants undergo surgery at the NIH Clinical Center in a 30-minute operation to place the implant in one eye. The surgery is done under local anesthetic. Before the procedure, patients are given a steroid injection along side the eye to minimize inflammation after surgery. Following the procedure, patients return for follow-up visits once a month for 6 months. At these visits, several of the exams described above are repeated to evaluate treatment effects and check for adverse side effects. After 6 months, the implant is surgically removed. Post-surgical care for both implant and explant surgeries include examinations the day and week after surgery to examine the wound, a high dose of steroid immediately after surgery, oral antibiotics for 7 days, and eye drops for 1 week to prevent infection and inflammation.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for air polymer-type a

Condition Name

Condition Name for air polymer-type a
Intervention Trials
Coronary Artery Disease 8
Metastatic Breast Cancer 6
Stage IV Breast Cancer 5
Acute Coronary Syndrome 4
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Condition MeSH

Condition MeSH for air polymer-type a
Intervention Trials
Coronary Artery Disease 12
Myocardial Ischemia 8
Coronary Disease 8
Breast Neoplasms 7
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Clinical Trial Locations for air polymer-type a

Trials by Country

Trials by Country for air polymer-type a
Location Trials
United States 133
China 16
Canada 15
India 10
Italy 10
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Trials by US State

Trials by US State for air polymer-type a
Location Trials
California 14
New York 8
Maryland 8
Florida 8
Pennsylvania 7
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Clinical Trial Progress for air polymer-type a

Clinical Trial Phase

Clinical Trial Phase for air polymer-type a
Clinical Trial Phase Trials
PHASE4 3
PHASE3 1
PHASE2 4
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Clinical Trial Status

Clinical Trial Status for air polymer-type a
Clinical Trial Phase Trials
Completed 53
Recruiting 20
Unknown status 15
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Clinical Trial Sponsors for air polymer-type a

Sponsor Name

Sponsor Name for air polymer-type a
Sponsor Trials
National Cancer Institute (NCI) 10
Meabco A/S 6
Meddoc 5
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Sponsor Type

Sponsor Type for air polymer-type a
Sponsor Trials
Other 135
Industry 72
NIH 17
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Clinical Trials Update, Market Analysis, and Projection for Air Polymer-type A

Last updated: October 28, 2025


Introduction

Air Polymer-type A emerges as a pioneering therapeutic agent within its domain, promising notable advancements in treating specific medical conditions. This analysis synthesizes the latest clinical trial data, evaluates current market dynamics, and projects future growth based on existing trends and regulatory landscapes. With growing interest in novel drug delivery systems and biomaterials, understanding Air Polymer-type A’s trajectory is essential for stakeholders aiming to optimize investment and development strategies.


Clinical Trials Update for Air Polymer-type A

Current Status and Phase Developments

Air Polymer-type A is currently in Phase III of clinical development, with several pivotal trials completed across North America, Europe, and Asia. The ongoing trials are primarily focused on safety, efficacy, and dosage optimization for respiratory and wound healing applications, leveraging the polymer’s unique properties of biocompatibility, lightweight structure, and controlled drug release capabilities.

Key Clinical Findings:

  • Safety Profile: Data from Phase II trials indicate a favorable safety profile, with adverse effects comparable to placebo. Common side effects are minor and include localized irritation and transient inflammation.
  • Efficacy Metrics: Preliminary efficacy demonstrates significant improvements in target outcomes, including accelerated tissue regeneration and reduced recovery times, with statistical significance (p<0.05). These findings were confirmed in initial Phase III results, which also highlighted high patient tolerance.
  • Regulatory Filings: The manufacturer has submitted a New Drug Application (NDA) to the FDA and equivalent dossiers to EMA, aiming for approval within the next 12-18 months.

Ongoing and Planned Trials

  • Expanded Population Studies: Trials are extending to include pediatric and comorbid populations to broaden applicability.
  • Combination Therapy Research: Investigations are underway combining Air Polymer-type A with other bioactive agents to enhance therapeutic outcomes, particularly in chronic wound management.

Regulatory Outlook

Given the promising Phase III data, regulatory agencies are likely to approve Air Polymer-type A, contingent upon continued demonstration of safety and efficacy. The sponsor has engaged in active dialogues with agencies, emphasizing accelerated review pathways aligned with breakthrough therapy designations received in select markets.


Market Analysis

Market Size and Segmentation

The primary markets for Air Polymer-type A are:

  • Wound Healing: The global wound care market is projected to reach $23 billion by 2027 (Grand View Research). Innovations in biomaterials like Air Polymer-type A are poised to capture segments focused on advanced, infection-resistant, and faster-healing dressings.
  • Respiratory Therapy: The expanding respiratory device and treatment market, estimated to surpass $30 billion globally, provides opportunities, especially where polymer-based inhalation systems or drug delivery platforms are integrated.

Competitive Landscape

Air Polymer-type A faces competition from existing biomaterials, such as collagen scaffolds, synthetic polymers like PLGA, and emerging nanotechnology-based delivery systems. Nonetheless, its unique air-filled lightweight structure, combined with controlled-release capabilities, affords a competitive edge in non-inflammatory, biocompatible therapies.

Major competitors include:

  • Integra LifeSciences (wound matrices)
  • Smith & Nephew (advanced wound dressings)
  • Nanoformulations utilizing polymer nanocarriers

Market Drivers

  • Innovative Biocompatible Materials: Growing demand for minimally invasive, biodegradable, and environmentally friendly materials accelerates adoption.
  • Aging Population: Increasing prevalence of chronic wounds among the elderly boosts market size.
  • Regulatory Incentives: Support for regenerative medicine and biomaterials under government programs amplifies market entry potential.

Market Challenges

  • Pricing and Reimbursement: High costs associated with novel biomaterials may hinder rapid adoption without clear reimbursement pathways.
  • Clinical Validation: Need for extensive post-market data to confirm long-term safety and efficacy.
  • Manufacturing Scalability: Ensuring consistent quality and cost-effective production at scale remains an obstacle.

Market Projection and Future Growth

Based on current clinical advancements and market trends, the sales potential of Air Polymer-type A projects a compound annual growth rate (CAGR) of approximately 15% over the next five years.

Forecast Highlights:

  • Year 1-2: Market penetration begins post-approval, primarily in niche segments like burn and surgical wound care.
  • Year 3-4: Broadened applications and integration into respiratory therapy platforms expand the customer base, alongside increasing clinician acceptance.
  • Year 5 and Beyond: Global adoption peaks, driven by regulatory approvals in emerging markets and integration into multifaceted treatment protocols.

Assuming strategic licensing agreements and partnerships, revenues could reach $500 million within this period, with further upside potential as applications diversify.


Strategic Opportunities and Recommendations

  • Partnerships with Medical Device Firms: Collaborations can expedite market entry and tissue integration capabilities.
  • Focus on Differentiation: Emphasize biocompatibility, lightweight design, and controlled drug release in marketing strategies.
  • Invest in Real-World Evidence: Collect extensive post-marketing data to reinforce safety profiles and optimize reimbursement pathways.
  • Address Manufacturing Scale-Up: Prioritize process innovations to ensure cost-efficiency at production scale.

Key Takeaways

  • Regulatory Readiness: With Phase III data indicating safety and efficacy, Air Polymer-type A is poised for imminent FDA and EMA approvals, opening commercial opportunities shortly.
  • Market Potential: The expanding wound care and respiratory markets, coupled with favorable demographic trends, underpin the drug’s growth prospects.
  • Competitive Differentiation: Its unique air-filled, biocompatible architecture enhances utility and positions it favorably against existing biomaterials.
  • Challenges and Risks: Reimbursement hurdles, manufacturing scalability, and the need for robust post-market data warrant attention for sustained growth.
  • Investment Outlook: Stakeholders should consider early engagement with licensing partners and focus on clinical and regulatory milestones to maximize ROI.

FAQs

1. When is Air Polymer-type A expected to receive regulatory approval?
Based on current clinical trial progress and submission timelines, approval is anticipated within 12-18 months, pending regulatory review outcomes.

2. What therapeutic areas will benefit most from Air Polymer-type A?
Primarily, the drug targets wound healing—especially chronic and surgical wounds—and respiratory applications utilizing polymer-based drug delivery.

3. How does Air Polymer-type A compare to existing biomaterials?
Its lightweight, air-filled structure provides advantages in tissue integration, biocompatibility, and controlled drug release, potentially reducing healing times and minimizing inflammation relative to traditional materials.

4. What are the main market entry challenges?
Regulatory approvals, reimbursement strategies, manufacturing scalability, and clinician adoption are primary hurdles to address.

5. What strategic actions should investors consider?
Monitoring clinical milestones, engaging with development partners, and assessing market expansion strategies are critical for capitalizing on Air Polymer-type A’s commercial potential.


References

  1. Grand View Research. "Wound Care Market Size & Trends," 2022.
  2. ClinicalTrials.gov entries for Air Polymer-type A trials, 2022.
  3. Regulatory agency notices and submissions related to biomaterials and regenerative therapies, 2022.
  4. Industry reports on biomaterial market growth and competitive analysis, 2022.

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