CLINICAL TRIALS PROFILE FOR TELMISARTAN

505(b)(2) Clinical Trials for Telmisartan

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	NCT02262572 ↗	Relative Bioavailability of Telmisartan and HCTZ in Two Experimental Formulations Compared to the Standard Formulation Telmisartan and HCTZ in Healthy Female and Male Subjects	Completed	Boehringer Ingelheim	Phase 1	2003-04-01	Study to assess the comparative pharmacokinetics of telmisartan/HCTZ in two new formulations based on sodium salt compared to the present commercial formulation (MicardisPlus®)

All Clinical Trials for Telmisartan

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00034840 ↗	Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose	Completed	Bayer	Phase 4	2001-10-01	The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.
NCT00034840 ↗	Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose	Completed	GlaxoSmithKline	Phase 4	2001-10-01	The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.
NCT00034840 ↗	Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose	Completed	Boehringer Ingelheim	Phase 4	2001-10-01	The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.
NCT00067977 ↗	HALT Progression of Polycystic Kidney Disease Study B	Completed	Boehringer Ingelheim	Phase 3	2006-01-01	The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD) will be assessed in two simultaneous multicenter randomized clinical trials targeting different levels of kidney function: 1) early disease defined by GFR >60 mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73 m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the first three years. Participants enrolled in Study B will be followed for five-to-eight years, with the average length of follow-up being six and a half years. Combination therapy will use angiotensin-converting-enzyme inhibitor (ACE-I) and an angiotensin-receptor blocker (ARB). Monotherapy will use ACE-I alone.
NCT00067977 ↗	HALT Progression of Polycystic Kidney Disease Study B	Completed	Merck Sharp & Dohme Corp.	Phase 3	2006-01-01	The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD) will be assessed in two simultaneous multicenter randomized clinical trials targeting different levels of kidney function: 1) early disease defined by GFR >60 mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73 m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the first three years. Participants enrolled in Study B will be followed for five-to-eight years, with the average length of follow-up being six and a half years. Combination therapy will use angiotensin-converting-enzyme inhibitor (ACE-I) and an angiotensin-receptor blocker (ARB). Monotherapy will use ACE-I alone.

Clinical Trial Conditions for Telmisartan

Condition Name

Condition Name for Telmisartan
Intervention	Trials
Hypertension	155
Healthy	40
Essential Hypertension	10
Hyperlipidemia	9

Condition MeSH

Condition MeSH for Telmisartan
Intervention	Trials
Hypertension	145
Essential Hypertension	23
Diabetes Mellitus	11
Hyperlipidemias	11

Clinical Trial Locations for Telmisartan

Trials by Country

Trials by Country for Telmisartan
Location	Trials
United States	394
Korea, Republic of	95
Canada	77
Australia	26
Spain	23

Trials by US State

Trials by US State for Telmisartan
Location	Trials
California	19
Georgia	16
Florida	16
Ohio	15
Texas	15

Clinical Trial Progress for Telmisartan

Clinical Trial Phase

Clinical Trial Phase for Telmisartan
Clinical Trial Phase	Trials
Phase 4	70
Phase 3	66
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Telmisartan
Clinical Trial Phase	Trials
Completed	219
Recruiting	18
Unknown status	16

Clinical Trial Sponsors for Telmisartan

Sponsor Name

Sponsor Name for Telmisartan
Sponsor	Trials
Boehringer Ingelheim	134
Chong Kun Dang Pharmaceutical	18
Bayer	12

Sponsor Type

Sponsor Type for Telmisartan
Sponsor	Trials
Industry	217
Other	134
NIH	9

Telmisartan: Clinical Trials, Market Analysis, and Projections

Introduction to Telmisartan

Telmisartan is a non-peptide angiotensin receptor blocker (ARB) widely used for the treatment of hypertension and the reduction of cardiovascular risk. It works by inhibiting the action of angiotensin II, leading to the dilation of blood vessels, enhanced circulation, and decreased strain on the heart[5].

Current Clinical Trials

Pilot Clinical Trial for COVID-19 Patients

A recent pilot clinical trial is investigating the safety and efficacy of telmisartan in mitigating pulmonary and cardiac complications in COVID-19 patients. This trial involves 40 symptomatic outpatients randomized to either telmisartan (40 mg) or a placebo, administered orally once daily for 21 days. The study monitors symptoms such as fever, dyspnea, and fatigue, as well as blood pressure and temperature. Blood samples and oropharyngeal swabs are collected at various study visits to evaluate the renin-angiotensin system (RAS) and various biomarkers of inflammation, coagulation, and fibrosis[1].

Market Analysis

Global Market Size and Growth

The global telmisartan market was valued at USD 3,567.30 million in 2023 and is projected to reach USD 4,661.27 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 3.4% during the forecast period of 2024-2032[2].

Regional Market Dynamics

• Asia-Pacific: This region is expected to grow at a higher CAGR of 5.5% during the forecast period, driven by a large patient population, particularly in China and India. Increased healthcare expenditures and awareness of telmisartan medications also fuel market growth in this region[2].
• North America: Currently the largest market for telmisartan, driven by a high prevalence of hypertension and cardiovascular diseases[2].

Market Drivers

• Increasing Prevalence of Hypertension and Cardiovascular Diseases: The rising incidence of these conditions, especially among older populations and in areas with lifestyle-related health hazards, is a significant driver of the telmisartan market[3][5].
• Growing Geriatric Population: The increase in the senior population contributes to the market growth due to the higher incidence of hypertension and cardiovascular diseases in this demographic[2][5].
• Approval of Generic Versions: The increase in approvals for generic telmisartan tablets and the rise in research in emerging nations are expected to drive market expansion[2][5].

Market Restraints

• Medication Shortages: Shortages of telmisartan are anticipated to hinder market growth. However, ongoing research and development in emerging economies are expected to mitigate this issue[2][5].

Advancements in Telmisartan Formulations

Extended-Release and Combination Therapies

Pharmaceutical companies are investing in research and development to enhance telmisartan formulations, including extended-release types and combinations with other drugs. For example, a novel triple combination pill, GMRx2, which includes telmisartan, amlodipine, and indapamide, has shown significant efficacy in controlling blood pressure compared to dual combinations. This multi-mechanism approach is designed to deliver optimal efficacy and safety while promoting patient adherence[4].

Strategic Collaborations and Partnerships

Companies are forming alliances to strengthen their position in the telmisartan market. Collaborations with local partners and research institutes help in creating innovative formulas and expanding geographical presence, particularly in emerging Asia-Pacific countries[3].

Distribution Channels

Hospital Pharmacies

Hospital pharmacies are expected to dominate the market due to the large number of prescriptions for high blood pressure and heart conditions. These pharmacies provide quick access to medications and encourage adherence to treatment plans, especially for high-risk groups with complicated medical backgrounds[3].

Consumer Insights and Market Trends

Awareness and Early Detection

Efforts to encourage early detection and treatment of hypertension are emphasizing the effectiveness of telmisartan in reducing cardiovascular incidents. The rising awareness of the advantages of using telmisartan for treating hypertension and cardiovascular conditions is expanding its market presence[3].

Government Initiatives

Government and non-government initiatives to spread awareness about blood pressure diseases, such as the ‘May Measurement Month & World Hypertension Day’ campaign by the Argentinian Society of Hypertension, are driving market growth[5].

Projections and Future Outlook

Market Size by 2032

The telmisartan market is expected to grow at a CAGR of 5.6% during the forecast period of 2024-2032 and attain a market value of USD 5.83 billion by 2032[3].

Emerging Markets

The Asia-Pacific region, particularly countries like India and China, presents lucrative opportunities due to a large patient base and the rising prevalence of cardiovascular diseases. The focus of leading manufacturers on expanding their geographical presence in these regions is expected to drive significant growth[2][5].

Key Takeaways

• Clinical Trials: Ongoing trials, such as the pilot study on COVID-19 patients, are exploring new applications of telmisartan.
• Market Growth: The global telmisartan market is expected to grow at a CAGR of 3.4% to 5.6% during the forecast period.
• Regional Dynamics: Asia-Pacific is expected to be the fastest-growing region due to a large patient population and increasing healthcare expenditures.
• Advancements: New formulations, including extended-release and combination therapies, are enhancing the market.
• Distribution: Hospital pharmacies are key distribution channels due to their role in managing high blood pressure and heart conditions.

FAQs

What is the primary use of telmisartan?

Telmisartan is primarily used for treating high blood pressure and reducing the risk of cardiovascular conditions, such as heart attacks, strokes, and kidney complications[3].

What are the key drivers of the telmisartan market?

The key drivers include the increasing prevalence of hypertension and cardiovascular diseases, the growing geriatric population, and the approval of generic versions of telmisartan[2][5].

Which region is expected to grow the fastest in the telmisartan market?

The Asia-Pacific region is expected to grow at a higher CAGR due to a large patient population and increasing healthcare expenditures[2].

What are the recent advancements in telmisartan formulations?

Recent advancements include extended-release types and combination therapies, such as the novel triple combination pill GMRx2, which combines telmisartan, amlodipine, and indapamide[4].

What are the main distribution channels for telmisartan?

Hospital pharmacies are the main distribution channels due to their role in managing high blood pressure and heart conditions[3].

Sources

1. Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients. CTV Veeva.
2. Telmisartan Market Size, Share and Forecast to 2030. Straits Research.
3. Telmisartan Market Size, Growth & Share Report | 2032. Expert Market Research.
4. Phase III trial results of novel triple combination pill for hypertension published in The Lancet. BioSpace.
5. Telmisartan Market Size, Share, Growth & Trends Report, 2027. Allied Market Research.