CLINICAL TRIALS PROFILE FOR CALCITRIOL

505(b)(2) Clinical Trials for Calcitriol

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	NCT00055263 ↗	A New Formulation of Calcitriol (DN-101) in Patients With Advanced Malignancies	Completed	Novacea	Phase 1	2002-03-01	The purposes of this study are to: - Test the safety of DN-101 in patients with advanced malignancies - Understand how fast the body absorbs, processes, and eliminates DN-101 - Determine the highest dose of DN-101 that is well tolerated by cancer patients - Learn how fast the body absorbs, processes, and eliminates DN-101 compared to the approved product

All Clinical Trials for Calcitriol

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000412 ↗	Osteoporosis Prevention After Heart Transplant	Completed	Merck Sharp & Dohme Corp.	Phase 3	1997-09-01	During the first year after a heart transplant, people often rapidly lose bone from their spine and hips. About 35 percent of people who receive heart transplants will suffer broken bones during the first year after transplantation. This study will compare the safety and effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D (calcitriol) in preventing bone loss at the spine and hip after a heart transplant. In this study, people who have had a successful heart transplant will receive either active alendronate and a "dummy pill" instead of calcitriol, or active calcitriol and a dummy pill instead of alendronate for the first year after their transplant, starting within 1 month after transplant surgery. We will measure bone density in the hip and spine at the start of the study and after 6 and 12 months, and will also check for broken bones in the spine. This research should lead to ways of preventing this crippling form of osteoporosis.
NCT00000412 ↗	Osteoporosis Prevention After Heart Transplant	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 3	1997-09-01	During the first year after a heart transplant, people often rapidly lose bone from their spine and hips. About 35 percent of people who receive heart transplants will suffer broken bones during the first year after transplantation. This study will compare the safety and effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D (calcitriol) in preventing bone loss at the spine and hip after a heart transplant. In this study, people who have had a successful heart transplant will receive either active alendronate and a "dummy pill" instead of calcitriol, or active calcitriol and a dummy pill instead of alendronate for the first year after their transplant, starting within 1 month after transplant surgery. We will measure bone density in the hip and spine at the start of the study and after 6 and 12 months, and will also check for broken bones in the spine. This research should lead to ways of preventing this crippling form of osteoporosis.
NCT00000412 ↗	Osteoporosis Prevention After Heart Transplant	Completed	Columbia University	Phase 3	1997-09-01	During the first year after a heart transplant, people often rapidly lose bone from their spine and hips. About 35 percent of people who receive heart transplants will suffer broken bones during the first year after transplantation. This study will compare the safety and effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D (calcitriol) in preventing bone loss at the spine and hip after a heart transplant. In this study, people who have had a successful heart transplant will receive either active alendronate and a "dummy pill" instead of calcitriol, or active calcitriol and a dummy pill instead of alendronate for the first year after their transplant, starting within 1 month after transplant surgery. We will measure bone density in the hip and spine at the start of the study and after 6 and 12 months, and will also check for broken bones in the spine. This research should lead to ways of preventing this crippling form of osteoporosis.

Clinical Trial Conditions for Calcitriol

Condition Name

Condition Name for Calcitriol
Intervention	Trials
Vitamin D Deficiency	12
Prostate Cancer	10
Chronic Kidney Disease	9

Condition MeSH

Condition MeSH for Calcitriol
Intervention	Trials
Kidney Diseases	32
Renal Insufficiency, Chronic	22
Hyperparathyroidism	16

Clinical Trial Locations for Calcitriol

Trials by Country

Trials by Country for Calcitriol
Location	Trials
United States	262
Canada	24
China	11
Italy	7
Malaysia	7

Trials by US State

Trials by US State for Calcitriol
Location	Trials
New York	32
California	18
Texas	15
Pennsylvania	12
Oregon	11

Clinical Trial Progress for Calcitriol

Clinical Trial Phase

Clinical Trial Phase for Calcitriol
Clinical Trial Phase	Trials
Phase 4	41
Phase 3	18
Phase 2/Phase 3	8

Clinical Trial Status

Clinical Trial Status for Calcitriol
Clinical Trial Phase	Trials
Completed	94
Unknown status	28
Terminated	21

Clinical Trial Sponsors for Calcitriol

Sponsor Name

Sponsor Name for Calcitriol
Sponsor	Trials
National Cancer Institute (NCI)	12
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	8
Novacea	8

Sponsor Type

Sponsor Type for Calcitriol
Sponsor	Trials
Other	175
Industry	55
NIH	33

Calcitriol: Clinical Trials, Market Analysis, and Projections

Introduction to Calcitriol

Calcitriol, the active metabolite of vitamin D, plays a crucial role in regulating calcium and phosphate metabolism in the body. It is widely used in the treatment of hyperparathyroidism, hypocalcemia in dialysis patients, and various metabolic bone disorders such as osteoporosis and rickets[1][2][5].

Clinical Trials and Research

Current Trials and Findings

Several clinical trials are ongoing to explore the therapeutic potential of calcitriol beyond its traditional uses.

• Hyperparathyroidism and Cancer: Early trials have shown that calcitriol can reduce the rate of PSA rise in prostate cancer patients, although these trials were often limited by dose-limiting hypercalcemia. Preclinical data suggest that calcitriol has additive or synergistic antineoplastic effects when combined with other agents like dexamethasone, retinoids, and certain chemotherapy drugs[1].

• Attention and Dopamine Release: A recent study is investigating whether acute calcitriol pre-treatment can enhance amphetamine-induced dopamine release and improve attention in healthy subjects. The hypothesis is that calcitriol pre-treatment will result in faster reaction times and higher accuracy on attention tests compared to placebo[4].

Future Directions

The ongoing research is expected to expand the therapeutic applications of calcitriol. For instance, the potential role of calcitriol in treating vitamin D deficiency-related conditions, such as tuberculosis, is being explored. Additionally, its use in combination therapies for bone diseases and kidney failure is a promising area of research[1][3].

Market Analysis

Market Size and Growth

The global calcitriol market has been experiencing significant growth driven by several key factors.

• Current Market Size: As of 2023, the global calcitriol market was valued at approximately USD 442 million, with projections indicating it will reach USD 680 million by 2031, growing at a CAGR of 4.88% from 2024 to 2031[5].
• Alternative Projections: Another estimate suggests the market was valued at USD 1.2 billion in 2025 and is expected to expand at a CAGR of 4.5% from 2025 to 2033[2].

Key Drivers of Growth

Several factors are driving the growth of the calcitriol market:

• Rising Prevalence of Chronic Kidney Disease (CKD) and Osteoporosis: The increasing incidence of these conditions is a major driver, as calcitriol is crucial in managing calcium and phosphate levels in patients with CKD and in treating osteoporosis[2][3][5].
• Growing Awareness of Vitamin D Deficiency: Increased awareness about the health impacts of vitamin D deficiency is leading to higher demand for calcitriol supplements[3][5].
• Technological Advancements: Innovations in drug delivery systems, such as controlled-release tablets and injectables, are improving the effectiveness and convenience of calcitriol therapy[3].

Market Trends

• Injectable Segment Dominance: The injectable segment is anticipated to hold the largest market share due to its ease of administration and better bioavailability[2].
• Hospital Pharmacies: Hospital pharmacies are expected to dominate the distribution channel segment due to the availability of a wide range of calcitriol products and the presence of trained healthcare professionals[2].
• Regional Dominance: North America, particularly the United States, is expected to dominate the market due to the high prevalence of CKD and osteoporosis, well-established healthcare infrastructure, and the presence of major pharmaceutical companies[2].

Emerging Markets

Emerging markets in Asia, Africa, and Latin America are expected to see significant growth due to increasing awareness of vitamin D deficiencies and improving healthcare infrastructure. These regions offer substantial growth potential, although affordability and regulatory challenges need to be addressed[3].

Challenges and Opportunities

Regulatory Challenges

The development and commercialization of calcitriol-based therapies are subject to stringent regulatory requirements. Delays in approval processes and concerns regarding the safety and efficacy of new formulations can hinder market growth[3].

Affordability

In many emerging economies, the cost of calcitriol-based treatments may limit accessibility. Pharmaceutical companies need to find ways to make their products more affordable to cater to a wider audience in these regions[3].

Opportunities

• New Formulations and Innovations: Continuous advancements in biotechnology and pharmaceutical formulations are leading to the development of new and more effective calcitriol-based therapies. This includes controlled-release tablets and injectables, which are improving patient compliance and outcomes[3].
• Combination Therapies: The trend towards combination therapies that pair calcitriol with other treatments for conditions like bone diseases and kidney failure is expected to drive further demand for calcitriol[3].

Key Takeaways

• Clinical Trials: Ongoing trials are exploring the use of calcitriol in various therapeutic areas, including cancer and attention disorders.
• Market Growth: The global calcitriol market is projected to grow significantly, driven by the rising prevalence of CKD and osteoporosis, growing awareness of vitamin D deficiency, and technological advancements.
• Market Trends: The injectable segment and hospital pharmacies are expected to dominate, with North America leading the regional market.
• Emerging Markets: Asia, Africa, and Latin America offer significant growth potential but face challenges related to affordability and regulatory approvals.
• Challenges and Opportunities: Regulatory hurdles and affordability issues need to be addressed, while new formulations and combination therapies present opportunities for growth.

FAQs

Q1: What are the primary uses of calcitriol?

Calcitriol is primarily used to treat hyperparathyroidism, hypocalcemia in dialysis patients, and various metabolic bone disorders such as osteoporosis and rickets.

Q2: What are the key drivers of the calcitriol market growth?

The key drivers include the rising incidence of chronic kidney disease (CKD) and osteoporosis, growing awareness of vitamin D deficiency, and technological advancements in drug delivery systems.

Q3: Which segment is expected to dominate the calcitriol market?

The injectable segment is anticipated to hold the largest market share due to its ease of administration and better bioavailability.

Q4: What are the challenges facing the calcitriol market?

The market faces challenges related to regulatory approvals, safety and efficacy concerns, and affordability issues in emerging economies.

Q5: What are the emerging markets for calcitriol?

Emerging markets in Asia, Africa, and Latin America are expected to see significant growth due to increasing awareness of vitamin D deficiencies and improving healthcare infrastructure.

Sources

1. DrugBank Online: Calcitriol: Uses, Interactions, Mechanism of Action.
2. Data Insights Market: Calcitriol Drug Charting Growth Trajectories: Analysis and Forecasts.
3. Market Research Intellect: Calcitriol Market Analysis: Breaking Down the Drivers Behind Rapid Growth.
4. Yale Medicine: Vitamin D as a Therapeutic Adjunct in the Stimulant Treatment of ADHD.
5. Market Research Intellect: Calcitriol Market Size and Projections.