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Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR PAROMOMYCIN SULFATE


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All Clinical Trials for Paromomycin Sulfate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000771 ↗ A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3 Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 To determine the effectiveness of oral paromomycin sulfate for 21 days compared to placebo in the treatment of cryptosporidiosis in patients with HIV infection. To evaluate the safety of oral paromomycin at two different doses. To explore whether paromomycin administered over a longer period provides additional benefit. In previous studies, patients with cryptosporidiosis demonstrated dramatic improvement with paromomycin therapy.
NCT00001128 ↗ Treatment of Chronic Cryptosporidiosis in AIDS Patients Terminated Genetics Institute N/A 1969-12-31 The purpose of this study is to see if it is safe and effective to add interleukin-12 (IL-12) to the standard drug combination (paromomycin plus azithromycin) used to treat cryptosporidiosis in AIDS patients. Doctors would like to find out if the combination of IL-12, paromomycin, and azithromycin is more effective than paromomycin and azithromycin alone. Cryptosporidiosis is a type of opportunistic (AIDS-related) infection seen in HIV-positive patients as their immune systems weaken. It is caused by a parasite that invades the intestinal tract, and it can cause watery diarrhea, stomach cramps, an upset stomach, or a fever. Antibiotics (paromomycin and azithromycin) are usually used to treat cryptosporidiosis. In this study, doctors will look at the effectiveness of using IL-12. IL-12 is a type of protein naturally produced by certain types of cells of the immune system and is believed to be important for immune function. Doctors hope that IL-12 can help boost the immune system in fighting cryptosporidiosis.
NCT00001128 ↗ Treatment of Chronic Cryptosporidiosis in AIDS Patients Terminated National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 The purpose of this study is to see if it is safe and effective to add interleukin-12 (IL-12) to the standard drug combination (paromomycin plus azithromycin) used to treat cryptosporidiosis in AIDS patients. Doctors would like to find out if the combination of IL-12, paromomycin, and azithromycin is more effective than paromomycin and azithromycin alone. Cryptosporidiosis is a type of opportunistic (AIDS-related) infection seen in HIV-positive patients as their immune systems weaken. It is caused by a parasite that invades the intestinal tract, and it can cause watery diarrhea, stomach cramps, an upset stomach, or a fever. Antibiotics (paromomycin and azithromycin) are usually used to treat cryptosporidiosis. In this study, doctors will look at the effectiveness of using IL-12. IL-12 is a type of protein naturally produced by certain types of cells of the immune system and is believed to be important for immune function. Doctors hope that IL-12 can help boost the immune system in fighting cryptosporidiosis.
NCT00216346 ↗ Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis Completed World Health Organization Phase 3 2003-06-01 Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for the treatment of VL. Paromomycin is an off-patent aminoglycoside antibiotic with anti-leishmaniasis activity. This study will test the safety and efficacy of paromomycin in the treatment of patients with VL in India.
NCT00216346 ↗ Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis Completed PATH Phase 3 2003-06-01 Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for the treatment of VL. Paromomycin is an off-patent aminoglycoside antibiotic with anti-leishmaniasis activity. This study will test the safety and efficacy of paromomycin in the treatment of patients with VL in India.
NCT00604955 ↗ Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis Completed PATH Phase 4 2007-10-01 This modular Program will first confirm the safety and efficacy of Paromomycin IM Injection when given to an expanded population in the outpatient setting in experienced VL centers and subsequently evaluate the effectiveness of an expanded access model of providing Paromomycin IM Injection to progressively more resource-constrained clinics in Bihar, India.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Paromomycin Sulfate

Condition Name

Condition Name for Paromomycin Sulfate
Intervention Trials
Visceral Leishmaniasis 4
Cryptosporidiosis 2
HIV Infections 2
Concentration-Time Profiles in Stomach & Intestine. 1
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Condition MeSH

Condition MeSH for Paromomycin Sulfate
Intervention Trials
Leishmaniasis 6
Leishmaniasis, Visceral 4
Leishmaniasis, Cutaneous 2
HIV Infections 2
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Clinical Trial Locations for Paromomycin Sulfate

Trials by Country

Trials by Country for Paromomycin Sulfate
Location Trials
United States 8
India 3
Sudan 2
Bangladesh 2
Ethiopia 2
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Trials by US State

Trials by US State for Paromomycin Sulfate
Location Trials
Texas 1
Ohio 1
New York 1
Missouri 1
Indiana 1
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Clinical Trial Progress for Paromomycin Sulfate

Clinical Trial Phase

Clinical Trial Phase for Paromomycin Sulfate
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Paromomycin Sulfate
Clinical Trial Phase Trials
Completed 7
Terminated 1
Unknown status 1
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Clinical Trial Sponsors for Paromomycin Sulfate

Sponsor Name

Sponsor Name for Paromomycin Sulfate
Sponsor Trials
PATH 3
National Institute of Allergy and Infectious Diseases (NIAID) 2
Fundacion Nacional de Dermatologia 1
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Sponsor Type

Sponsor Type for Paromomycin Sulfate
Sponsor Trials
Other 20
NIH 2
Industry 1
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Paromomycin Sulfate: Clinical Trials, Market Analysis, and Projections

Overview of Paromomycin Sulfate

Paromomycin sulfate is an aminoglycoside sulfate salt, derived from the treatment of paromomycin with sulfuric acid. It is a potent antimicrobial agent used to treat various parasitic infections, including acute and chronic intestinal amoebiasis, giardiasis, leishmaniasis, and tapeworm infections. Additionally, it is used in combination with other drugs to manage symptoms of hepatic coma, a complicated liver disease[2][5].

Clinical Trials Update

Recent and Ongoing Trials

Several clinical trials have been conducted or are ongoing to evaluate the efficacy and safety of paromomycin sulfate.

  • Phase 2 Trial for Leishmaniasis: A Phase 2 trial involving 110 patients compared the efficacy of paromomycin combined with miltefosine against liposomal amphotericin B combined with miltefosine. The results showed positive outcomes for the paromomycin combination, with high cure rates ranging from 90.3% to 100%[1].
  • Phase 3 Trial for Visceral Leishmaniasis: A Phase 3 trial with 439 patients evaluated the combination of paromomycin and miltefosine. The study reported positive results, indicating the efficacy of this combination in treating visceral leishmaniasis[1].
  • Topical Treatment: Another study focused on the topical treatment of leishmaniasis using paromomycin alone. The results showed varying efficacy rates depending on the dosage and duration of treatment[1].

Efficacy in Specific Conditions

  • Cryptosporidial Enteritis: A prospective, randomized, double-blind, placebo-controlled trial found that paromomycin was not more effective than placebo in treating symptomatic cryptosporidial enteritis in HIV-infected adults. However, the study acknowledged that the sample size was too small to definitively reject the usefulness of paromomycin for this condition[4].

Market Analysis

Current Market Trends

The paromomycin sulfate market is driven by several key factors:

  • Rise in Geriatric Population: An increase in the geriatric population suffering from chronic intestinal and bowel disorders is a significant driver of the market[5].
  • Sedentary Lifestyle: The adoption of sedentary lifestyles leading to gastrointestinal diseases also increases the demand for paromomycin sulfate[5].
  • COVID-19 Impact: The COVID-19 pandemic has presented opportunities for pharmaceutical and biotech companies, including those manufacturing paromomycin sulfate, due to the increased demand for treatment drugs and vaccines. This has had a positive impact on the market growth[2][5].

Market Challenges

Despite the growth drivers, the market faces some challenges:

  • Side Effects: Common side effects such as vomiting and loss of appetite can slow the growth rate of the paromomycin sulfate market[5].
  • Competition: The market is competitive, with several key players including Pfizer, Changrui Pharm, ERFA Canada, Shanhe Pharm, and Kaifeng Pharm[2].

Competitive Landscape

The competitive landscape of the paromomycin sulfate market is intense, with multiple players vying for market share. Porter’s five forces analysis highlights the potency of buyers and suppliers in the market, indicating a competitive intensity that will shape the market in the coming years[2].

Market Projections

Future Estimations

The paromomycin sulfate market is expected to grow significantly from 2020 to 2030. Here are some key projections:

  • Market Growth Scenario: The market is quantitatively analyzed to highlight the growth scenario, indicating a steady increase in demand driven by the factors mentioned above[2][5].
  • Opportunities and Challenges: The rise in awareness among the population for the use of medications available for acute bowel disorders paves the way for new opportunities. However, the market must navigate challenges such as side effects and competition[5].

Impact of COVID-19

The COVID-19 pandemic has had a significant impact on the pharmaceutical and biotechnology industries, including the paromomycin sulfate market. The increased demand for treatment drugs and vaccines has presented huge opportunities for manufacturers, contributing to the market's growth[2][5].

Key Players

The paromomycin sulfate market is dominated by several key players:

  • Pfizer: Known for its extensive pharmaceutical portfolio, Pfizer is a major player in the market.
  • Changrui Pharm: A Chinese pharmaceutical company with a strong presence in the global market.
  • ERFA Canada: A Canadian company contributing to the global supply of paromomycin sulfate.
  • Shanhe Pharm: Another Chinese company with significant market share.
  • Kaifeng Pharm: A Chinese pharmaceutical company involved in the production and distribution of paromomycin sulfate[2].

Key Takeaways

  • Clinical Efficacy: Paromomycin sulfate has shown positive results in treating various parasitic infections, although its efficacy in certain conditions like cryptosporidial enteritis is questionable.
  • Market Drivers: The rise in the geriatric population and sedentary lifestyles are key drivers of the market.
  • COVID-19 Impact: The pandemic has positively impacted the market due to increased demand for treatment drugs.
  • Challenges: Side effects and competition are significant challenges facing the market.
  • Future Projections: The market is expected to grow steadily from 2020 to 2030, driven by increasing demand and awareness.

FAQs

What is Paromomycin Sulfate?

Paromomycin sulfate is an aminoglycoside sulfate salt used to treat various parasitic infections, including intestinal amoebiasis, giardiasis, leishmaniasis, and tapeworm infections.

What are the common side effects of Paromomycin Sulfate?

Common side effects include vomiting and loss of appetite.

Which companies are key players in the Paromomycin Sulfate market?

Key players include Pfizer, Changrui Pharm, ERFA Canada, Shanhe Pharm, and Kaifeng Pharm.

How has COVID-19 impacted the Paromomycin Sulfate market?

The COVID-19 pandemic has increased demand for treatment drugs, positively impacting the market growth.

What are the future projections for the Paromomycin Sulfate market?

The market is expected to grow significantly from 2020 to 2030, driven by increasing demand and awareness.

What are the primary uses of Paromomycin Sulfate?

Paromomycin sulfate is primarily used to treat acute and chronic intestinal amoebiasis, giardiasis, leishmaniasis, and tapeworm infections, and to manage symptoms of hepatic coma.

Sources

  1. Synapse: Paromomycin Sulfate - Drug Targets, Indications, Patents - Synapse
  2. EINPresswire: Paromomycin Sulfate Market New Opportunities, Top Trends, Rising Demand, Emerging Growth, Business Development
  3. ClinicalTrials.gov: A PHASE I, OPEN-LABEL STUDY TO ASSESS LUNG PHARMACOKINETICS AND SAFETY OF A SINGLE DOSE OF APRAMYCIN ADMINISTERED INTRAVENOUSLY IN HEALTHY ADULT SUBJECTS
  4. Oxford Academic: Paromomycin: No More Effective than Placebo for Treatment of Symptomatic Cryptosporidial Enteritis
  5. Allied Market Research: Paromomycin Sulfate Market Size, Share Forecast- 2030

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