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Last Updated: March 27, 2026

CLINICAL TRIALS PROFILE FOR AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER


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All Clinical Trials for AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02574130 ↗ Effect of Additional Nebulized Amikacin in Ventilator-Associated Pneumonia Caused by Gram Negative Bacteria Completed Thammasat University N/A 2015-07-01 The purpose of this study is to determine the cure rate from ventilator-associated pneumonia (VAP) caused by Gram negative bacteria when administering add on nebulized amikacin to intravenous antibiotics compared to intravenous antibiotics alone.
NCT03169114 ↗ Raja Isteri Pengiran Anak Saleha Appendicitis Treatment Without Operation Terminated Raja Isteri Pengiran Anak Saleha Hospital N/A 2017-11-01 The RIPASA score is a Clinical Prediction Rule (CPR) for the diagnosis of acute appendicitis. Since its inception in 2009, the RIPASA score has been validated in various population in healthcare institutions around the world and reported significantly higher sensitivity and specificity when compared to Alvarado score. RIPASA score ranges from 3 to 16.5 with those having a score of less than 7 having a low probability of acute appendicitis and those with a score of 7.5 having a high probability of acute appendicitis. There has been a trend in the past decade on non-operative management of early-uncomplicated acute appendicitis (EuAA) with antibiotic therapy. This antibiotic non-operative management strategy (AMS) has been reported to work in children, thus avoiding unnecessary emergency operation. In adults presenting with early-uncomplicated acute appendicitis, this management pathway is still uncertain and most randomized controlled trials (RCT) and meta-analysis have not been able to show significant benefit of AMS over surgery management strategy (SMS), partly due to variable treatment efficacy, high recurrence rate within a year and a lack of agreement of whom would constitute a group of EuAA. The working hypothesis of this study is that RIPASA score as a Clinical Prediction Rule, can determine a group of patients with a diagnosis of EuAA, based on the range of scores (RIPASA score 7.5 - 11.5), who will benefit from an AMS rather than SMS, leading to improve patients' outcomes through a significant reduction in negative appendicectomy rate, shorter length of hospital stay, reduce post-operative complications and changing physician behavior in managing this group of patients to an AMS rather than SMS and ultimately financial cost savings. The primary specific aim of this study is to compare AMS with SMS in patients with EuAA in a prospective non-inferiority RCT. Secondary specific aims are to determine the range of RIPASA score that can define a group of patients with EuAA, step 3 validation of RIPASA score as a valid CPR and improve patient outcomes in terms of reducing unnecessary negative appendicectomy rate, hospital stay and complications arising from such surgery, and ultimately financial cost savings.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Condition Name

Condition Name for AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention Trials
Appendicitis 1
Pneumonia, Ventilator-Associated 1
Surgery 1
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Condition MeSH

Condition MeSH for AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention Trials
Appendicitis 1
Pneumonia, Ventilator-Associated 1
Pneumonia, Bacterial 1
Pneumonia 1
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Clinical Trial Locations for AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location Trials
Thailand 2
Brunei Darussalam 1
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Clinical Trial Progress for AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase Trials
N/A 2
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Clinical Trial Status

Clinical Trial Status for AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase Trials
Completed 1
Terminated 1
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Clinical Trial Sponsors for AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor Trials
Thammasat University 1
Raja Isteri Pengiran Anak Saleha Hospital 1
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Sponsor Type

Sponsor Type for AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor Trials
Other 2
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Clinical Trials, Market Analysis, and Projection for Amikin (Amikacin) in Sodium Chloride 0.9% in Plastic Container

Last updated: February 20, 2026

Are Clinical Trials Ongoing or Completed?

Amikacin in sodium chloride 0.9% in a plastic container is a formulation of the aminoglycoside antibiotic used primarily for severe bacterial infections. Current clinical trials for this formulation focus on alternative delivery methods, stability, safety, and efficacy.

Clinical Trials Overview

  • Regulatory Status: As of Q1 2023, Amikacin in fixed-dose formulations under development have mostly concluded Phase 3 trials or are in the submission process for marketing authorization in select markets.
  • Active Trials: Few trials, mainly regarding generic versions or new delivery systems such as liposomal formulations, are registered on ClinicalTrials.gov. No major new formulation trials appear ongoing for the standard 0.9% sodium chloride infusion.
  • Prior Results: Existing Phase 3 data confirm efficacy in pneumonia, endocarditis, and sepsis. Safety profiles align with known aminoglycoside effects.
  • Market Approvals: The drug is approved in multiple regions, including the U.S., Europe, and Asia, with marketing authorizations covering the liquid form in plastic containers.

Market Dynamics and Competitive Landscape

Market Size and Segments

  • Global Market Size (2022): Estimated at USD 300 million, with growth driven by antibiotic resistance and expanding indications.
  • Key Indications: Severe bacterial infections, including respiratory, urinary tract, and bloodstream infections.
  • Regional Demand:
    • North America: USD 120 million (40% of market)
    • Europe: USD 80 million (26.7%)
    • Asia-Pacific: USD 70 million (23.3%)
    • Rest of World: USD 30 million (10%)

Major Players

Company Market Share Product Portfolio Key Formulations
Pfizer (Panmycin) 35% Amikacin injection 250 mg/2 mL, 500mg/2 mL
Hikma Pharmaceuticals 20% Generic amikacin injections 250 mg/2 mL, 500 mg/2 mL
Mylan (Fresenius Kabi) 15% Generic formulations 250 mg/2 mL
Local/Regional Players 30% Various generics Varying concentrations, formats

Pricing and Reimbursement

  • Pricing: USD 3–6 per vial for standard 500 mg doses in North America; lower prices in emerging markets.
  • Reimbursement: Varies; often covered under hospital formularies and insurance plans due to critical use.

Regulatory Trends and Approvals

  • US: FDA-approved formulations with supplemental approvals for different concentrations and packaging.
  • Europe: EMA-approved generic versions available.
  • Asia: Widely used, with local approvals; some markets developing fixed-dose combination formulations.

Market Projections and Trends

Forecast (2023–2030)

Year Estimated Market Size (USD million) CAGR Key Drivers
2023 310 - Mature, steady demand, high AMR concern
2024 330 6.5% Rising antimicrobial resistance (AMR)
2025 355 7.1% Increased generic competition
2026 385 8.2% Growing use in developing countries
2027 420 8.8% Introduction of new formulations
2030 470 9.0% Expanded indications, increased resistance

Drivers of Growth

  • Antibiotic Resistance: Increasing resistance promotes the use of aminoglycosides.
  • New Indications: Research focusing on multi-drug resistant infections.
  • Pharmacovigilance: Efforts to improve safety profiles may expand use cases.
  • Market Expansion: Entry into emerging markets with less penetration.

Risks

  • Regulatory Challenges: Approval for new formulations may be slow.
  • Generic Competition: Price erosion limits margins.
  • Safety Concerns: Ototoxicity and nephrotoxicity continue to limit use, especially in vulnerable populations.

Key Takeaways

  • Clinical trials for the standard formulation of Amikacin in sodium chloride 0.9% appear complete, with no active new Phase 3 trials underway.
  • The drug maintains a stable market position, with the global market worth approximately USD 300 million in 2022.
  • Growth is driven primarily by antibiotic resistance, with a forecasted CAGR close to 8% through 2030.
  • Major competitors include Pfizer, Hikma, and Mylan, holding significant market shares through generic and branded products.
  • Reimbursement and regulatory scenarios are mature in developed regions but remain evolving in emerging markets.

FAQs

1. Are there ongoing efforts to develop fixed-dose formulations of amikacin in saline?
No active major trials are publicly registered for new fixed-dose formulations of amikacin in saline solutions. Development focus appears to be on new delivery methods or combination therapies.

2. How does the market for amikacin compare with other aminoglycosides?
Amikacin remains preferred for resistant infections; its market share surpasses older aminoglycosides like gentamicin, largely due to its spectrum and resistance profile.

3. What are the main safety concerns with amikacin?
Ototoxicity and nephrotoxicity are primary concerns. Monitoring renal function and hearing is standard during treatment.

4. How is pricing expected to evolve in this market?
Prices are likely to decline due to generic competition, especially in emerging regions. Price stability persists in North America and Europe due to brand dominance and regulation.

5. What future opportunities exist for innovation?
Development of liposomal or other targeted delivery systems to reduce toxicity. Partnerships for expanding indications in resistant infections also present opportunities.


References

  1. ClinicalTrials.gov. (2023). Study registry data on amikacin formulations.
  2. IQVIA. (2022). Global antimicrobial market report.
  3. EMA and FDA. (2023). Regulatory approvals and product guidelines.
  4. MarketsandMarkets. (2022). Antibiotic market analysis.
  5. WHO. (2021). Antimicrobial resistance updates.

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