CLINICAL TRIALS PROFILE FOR TETRACYCLINE HYDROCHLORIDE

505(b)(2) Clinical Trials for Tetracycline Hydrochloride

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
OTC	NCT04716426 ↗	APT™ T3X on the COVID-19 Contamination Rate	Completed	Santa Casa de Misericórdia de Porto Alegre	N/A	2021-01-28	The new coronavirus 2019 (COVID-19) was declared a pandemic by the World Health Organization (WHO), due to the alarming levels of spread, severity and inaction. Dealing with COVID-19 must be done on different fronts, such as mitigation, treatment and prevention. Therefore, strategies and therapies that can help reduce the COVID-19 rate of contamination are still important alternatives at this time of the pandemic. The Advanced Penetration Technology™ (APT™) is intellectual property owned by Patient Focused Tele-Health, LLC, a Rockwall, Texas based company. The company's focus is improving over-the-counter (OTC) topical formulations, allowing consumers better therapeutic outcomes with non-prescription medications. The Advanced Penetration Technology™ (APT™) is a patent-pending, proprietary transdermal dual carrier formulation. This formulation provides improved dermal penetration and efficacy of topical API's. Additionally, the APT™ imparts both a mechanical and biochemical effect on the microbe/fungal cell walls providing a highly effective method of destruction of microbes. These unique properties impart the broad spectrum anti-viral capability to the APT™ Tetracycline 3% formulation, breaking barriers in pharmacology and virology. The topical formulation APT™ Tetracycline 3% formulation (APT ™ T3X), is a FDA registered, Non-Prescription product. This formulation is used in an off label manner as an intranasal application for prevention of COVID-19 and other viruses. The APT™ T3X as a topical application will penetrate through and into the mucus layer and deeper. This barrier of coverage will provide a mitigation effect to decrease the viral load of exposure and infection. The efficacy of APT™ T3X is due to disrupting the lipid envelope in seconds, hence neutralizing the virus. Previous tests were performed with APT™ T3X and the results found were promising. However, these tests were performed only in vitro and clinical studies demonstrating the ability of the APT™ T3X to decrease viral exposure and contamination by COVID-19 are necessary to confirm the possible prophylactic effect, allowing the formulation to be widely distributed to the general population. Therefore, the aim of this project is to evaluate the efficacy of the APT™ T3X compared to placebo to decrease COVID-19 contamination rate in humans.
OTC	NCT04716426 ↗	APT™ T3X on the COVID-19 Contamination Rate	Completed	University of Nove de Julho	N/A	2021-01-28	The new coronavirus 2019 (COVID-19) was declared a pandemic by the World Health Organization (WHO), due to the alarming levels of spread, severity and inaction. Dealing with COVID-19 must be done on different fronts, such as mitigation, treatment and prevention. Therefore, strategies and therapies that can help reduce the COVID-19 rate of contamination are still important alternatives at this time of the pandemic. The Advanced Penetration Technology™ (APT™) is intellectual property owned by Patient Focused Tele-Health, LLC, a Rockwall, Texas based company. The company's focus is improving over-the-counter (OTC) topical formulations, allowing consumers better therapeutic outcomes with non-prescription medications. The Advanced Penetration Technology™ (APT™) is a patent-pending, proprietary transdermal dual carrier formulation. This formulation provides improved dermal penetration and efficacy of topical API's. Additionally, the APT™ imparts both a mechanical and biochemical effect on the microbe/fungal cell walls providing a highly effective method of destruction of microbes. These unique properties impart the broad spectrum anti-viral capability to the APT™ Tetracycline 3% formulation, breaking barriers in pharmacology and virology. The topical formulation APT™ Tetracycline 3% formulation (APT ™ T3X), is a FDA registered, Non-Prescription product. This formulation is used in an off label manner as an intranasal application for prevention of COVID-19 and other viruses. The APT™ T3X as a topical application will penetrate through and into the mucus layer and deeper. This barrier of coverage will provide a mitigation effect to decrease the viral load of exposure and infection. The efficacy of APT™ T3X is due to disrupting the lipid envelope in seconds, hence neutralizing the virus. Previous tests were performed with APT™ T3X and the results found were promising. However, these tests were performed only in vitro and clinical studies demonstrating the ability of the APT™ T3X to decrease viral exposure and contamination by COVID-19 are necessary to confirm the possible prophylactic effect, allowing the formulation to be widely distributed to the general population. Therefore, the aim of this project is to evaluate the efficacy of the APT™ T3X compared to placebo to decrease COVID-19 contamination rate in humans.

All Clinical Trials for Tetracycline Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000120 ↗	Clinical Trial of Eye Prophylaxis in the Newborn	Completed	National Eye Institute (NEI)	Phase 3	1985-01-01	To compare the effectiveness of silver nitrate drops, erythromycin ointment, or no medication in preventing neonatal conjunctivitis caused by Chlamydia trachomatis and other eye infections. To compare side effects of the two prophylactic agents.
NCT00001683 ↗	A Phase I Study of Oral COL-3 (NSC-683551), a Matrix Metalloproteinase Inhibitor, in Patients With Refractory Metastatic Cancer	Completed	National Cancer Institute (NCI)	Phase 1	1997-10-01	Matrix metalloproteinases (MMPs) are a class of membrane bound enzymes that are involved in the degradation of the extracellular matrix. MMP-2 and MMP-9 have been associated with the progression of cancer. It is hypothesized than an imbalance between MMPs and MMP inhibitors allows the destruction of the extracellular matrix and enhances the ability of the tumor cells to grow and metastasize. By inhibiting MMPs, it is thought that angiogenesis and metastasis can be inhibited. This is a phase I study of COL-3, an oral matrix metalloproteinase inhibitor, in patients with refractory metastatic cancer. COL-3 is a chemically modified tetracycline derivative. Patients must have clinically progressive disease documented within 1 month prior to entry to be eligible for treatment. Patients must have also failed therapy of proven efficacy for their disease and have an ECOG performance status of less or equal than 2. Patients must be willing to travel from their home to the NIH for follow-up visits. Patients with brain metastases or primary CNS malignancies are not eligible. Concurrent therapy for their cancer (i.e., radiation therapy, chemotherapy, etc.) will preclude participation. We will be defining the maximum tolerated dose, the toxicity profile, characterizing the pharmacokinetics, and evaluating the effect of COL-3 on several biological endpoints.
NCT00002682 ↗	Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach	Completed	National Cancer Institute (NCI)	Phase 2	1995-08-10	RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
NCT00002682 ↗	Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach	Completed	M.D. Anderson Cancer Center	Phase 2	1995-08-10	RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.

Clinical Trial Conditions for Tetracycline Hydrochloride

Condition Name

Condition Name for Tetracycline Hydrochloride
Intervention	Trials
Helicobacter Pylori Infection	57
Schizophrenia	5
Acne Vulgaris	4
Syphilis	4

Condition MeSH

Condition MeSH for Tetracycline Hydrochloride
Intervention	Trials
Helicobacter Infections	47
Infections	43
Infection	35
Communicable Diseases	25

Clinical Trial Locations for Tetracycline Hydrochloride

Trials by Country

Trials by Country for Tetracycline Hydrochloride
Location	Trials
United States	149
China	36
Taiwan	27
Canada	12
Brazil	9

Trials by US State

Trials by US State for Tetracycline Hydrochloride
Location	Trials
California	16
Texas	9
Ohio	8
Massachusetts	8
Florida	7

Clinical Trial Progress for Tetracycline Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Tetracycline Hydrochloride
Clinical Trial Phase	Trials
Phase 4	88
Phase 3	32
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for Tetracycline Hydrochloride
Clinical Trial Phase	Trials
Completed	106
Recruiting	37
Not yet recruiting	29

Clinical Trial Sponsors for Tetracycline Hydrochloride

Sponsor Name

Sponsor Name for Tetracycline Hydrochloride
Sponsor	Trials
National Taiwan University Hospital	12
Shandong University	11
University of California, San Francisco	8

Sponsor Type

Sponsor Type for Tetracycline Hydrochloride
Sponsor	Trials
Other	364
Industry	39
NIH	18

Tetracycline Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Tetracycline hydrochloride (TCH) is a widely used antibiotic belonging to the tetracycline class, known for its broad-spectrum antibacterial properties. This article delves into the current clinical trials, market analysis, and future projections for TCH, highlighting its applications, market dynamics, and growth prospects.

Clinical Trials and Effects on Cells

Recent studies have focused on the effects of TCH on various cell types, particularly in the context of tissue engineering and regenerative medicine.

Impact on Dental Pulp Stem Cells (DPSC)

A study on the effects of TCH on DPSC revealed that concentrations above 50 μg/ml negatively affect the differentiation capability of these cells. At higher concentrations (above 250 μg/ml), TCH also adversely affects cell survival, proliferation, and migration. The study used various techniques such as phalloidin staining, live-dead staining, MTS assay, and real-time PCR to assess these changes. The results indicated down-regulation of genes essential for osteogenic and adipogenic differentiation, highlighting the need for careful consideration of TCH concentrations in tissue engineering applications[1].

Market Analysis

Global Market Overview

The global tetracyclines market, which includes TCH, was valued at USD 33.64 billion in 2021 and is projected to reach USD 40.99 billion by 2029, growing at a CAGR during the forecast period of 2022-2029. This growth is driven by several key factors:

Increasing Prevalence of Infectious Diseases

The rising incidence of infectious diseases globally fuels the demand for antibiotics like TCH. Tetracyclines are effective against a wide range of bacteria, chlamydiae, mycoplasmata, protozoans, and rickettsiae, making them crucial in treating various infections[3].

Healthcare Infrastructure and Expenditure

Increasing healthcare expenditure and improvements in healthcare infrastructure are significant drivers. Governments and private entities are investing heavily in healthcare, which enhances the availability and accessibility of medical services, including antibiotics[3][5].

Surging Geriatric Population

The global geriatric population is expected to grow significantly, from 727 million in 2020 to 1.5 billion by 2050. This demographic shift increases the demand for antibiotics, as older individuals are more susceptible to infections due to their weaker immune systems[3].

Regional Markets

India Tetracycline Market

In India, the tetracycline market was valued at USD 90.18 million in 2024 and is anticipated to grow with a CAGR of 3.15% through 2030. The market is driven by the rising incidence of infectious diseases, increased healthcare expenditure, and the expansion of the pharmaceutical industry. North India, particularly states like Uttar Pradesh, Punjab, and Haryana, holds a substantial share of the market due to its well-established healthcare infrastructure[5].

Market Dynamics

Drivers

• Increasing Prevalence of Infectious Diseases: Tetracyclines are used to treat various bacterial infections, including pneumonia, respiratory diseases, and certain types of food poisoning.
• Healthcare Infrastructure: Improvements in healthcare infrastructure and rising healthcare expenditure support the market growth.
• Surging Geriatric Population: The growing elderly population increases the demand for antibiotics.
• Availability of Generics: The presence of a large number of generic tetracyclines reduces treatment costs, especially in emerging markets[3][5].

Opportunities

• Technological Advancements: Continuous research and development in formulation technologies and delivery methods enhance the efficacy and safety of TCH.
• Emerging Markets: Growing healthcare awareness and increasing disposable income in emerging markets provide new opportunities for the tetracyclines market[3][5].

Projections and Future Outlook

Market Growth

The global tetracyclines market is expected to continue its growth trajectory, driven by the increasing prevalence of infectious diseases, advancements in healthcare infrastructure, and the surging geriatric population. The market is projected to reach USD 40.99 billion by 2029, with a steady CAGR during the forecast period[3].

Regional Growth

In India, the tetracycline market is anticipated to grow steadily, driven by the rising demand for antibiotics in both human and veterinary sectors. The market is expected to reach USD 108.88 million by 2030, with a CAGR of 3.15% during the forecast period[5].

Clinical and Therapeutic Applications

TCH is expected to remain a crucial antibiotic in treating various infections, including acne, Lyme disease, and malaria. Its application in regenerative medicine, particularly in tissue engineering, will require further studies to optimize its use without adverse effects on stem cells[1][3].

Key Takeaways

• Clinical Impact: TCH affects DPSC differentiation and survival at certain concentrations, highlighting the need for precise application in tissue engineering.
• Market Growth: The global tetracyclines market is projected to grow significantly, driven by increasing infectious diseases, healthcare infrastructure improvements, and a surging geriatric population.
• Regional Markets: India's tetracycline market shows steady growth, driven by rising healthcare expenditure and the expansion of the pharmaceutical industry.
• Future Outlook: TCH will continue to be a vital antibiotic, with ongoing research needed to optimize its use in various therapeutic applications.

FAQs

What are the primary uses of Tetracycline Hydrochloride?

Tetracycline Hydrochloride is used to treat various bacterial infections, including pneumonia, respiratory diseases, acne, Lyme disease, and malaria. It is also effective against certain types of food poisoning and can prevent plague and tularemia[3].

How does Tetracycline Hydrochloride affect stem cells?

At concentrations above 50 μg/ml, TCH negatively affects the differentiation capability of dental pulp stem cells (DPSC). Higher concentrations (above 250 μg/ml) also adversely affect cell survival, proliferation, and migration[1].

What drives the growth of the global tetracyclines market?

The growth is driven by the increasing prevalence of infectious diseases, improvements in healthcare infrastructure, and the surging geriatric population. Additionally, the availability of generics and technological advancements contribute to market growth[3].

What is the projected market size for tetracyclines by 2029?

The global tetracyclines market is projected to reach USD 40.99 billion by 2029[3].

How is the Indian tetracycline market expected to grow?

The Indian tetracycline market is anticipated to grow with a CAGR of 3.15% through 2030, reaching USD 108.88 million by 2030. The growth is driven by rising healthcare expenditure, the expansion of the pharmaceutical industry, and increasing awareness of infectious diseases[5].

Sources

1. Frontiers in Pharmacology: "Effect of tetracycline hydrochloride application on dental pulp stem cells" - This study evaluates the effects of TCH on DPSC metabolism and differentiation.
2. Cognitivemarketresearch: "Global Tetracycline Hydrochloride Market Report 2024 Edition" - This report provides a comprehensive market analysis, including market size, revenue, and forecast.
3. Data Bridge Market Research: "Global Tetracyclines Market – Industry Trends and Forecast to 2029" - This report details the global tetracyclines market, including market size, drivers, and forecast.
4. JAMA Network: "Acne Vulgaris: Double-Blind Trial Comparing Tetracycline and Clindamycin" - This study compares the efficacy of TCH and clindamycin in treating acne.
5. Techsciresearch: "India Tetracycline Market By Size, Share and Forecast 2030F" - This report provides an in-depth analysis of the Indian tetracycline market, including market size, drivers, and forecast.