CLINICAL TRIALS PROFILE FOR HECTOROL

All Clinical Trials for Hectorol

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00123461 ↗	Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism	Completed	Genzyme, a Sanofi Company	Phase 4	2005-07-01	The purpose of this study is to demonstrate the safety and effectiveness of Hectorol® (doxercalciferol) capsules in treating patients with Stage 3 or Stage 4 chronic kidney disease (CKD) with secondary hyperparathyroidism who have vitamin D levels in the normal range. Previous studies with doxercalciferol were conducted in patients who had low levels of vitamin D.
NCT00257920 ↗	A Study of Zemplar® Injection and Hectorol® Injection on Intestinal Absorption of Calcium in Chronic Kidney Disease	Completed	Abbott	Phase 4	2006-06-01	The purpose of this study is to evaluate the effects of Zemplar® Injection and Hectorol® Injection on intestinal calcium absorption in Chronic Kidney Disease Stage 5 subjects on hemodialysis.
NCT00418600 ↗	A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis	Completed	Genzyme, a Sanofi Company	Phase 4	2006-11-01	Hectorol is a safe and effective treatment of secondary hyperparathyroidism in hemodialysis patients. Hectorol (doxercalciferol capsules) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and in pre-dialysis patients with Stage 3 or Stage 4 chronic kidney disease. Hectorol (doxercalciferol injection) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. This protocol will determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting subject from Hectorol (doxercalciferol injection.) The study will enroll hemodialysis patients that have been controlled on intravenous Hectorol. the information gained from this study will be a useful guide for physicians in managing CKD Stage 5 patients for whom a change from intravenous to oral vitamin D administration is appropriate.
NCT00454350 ↗	A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis	Completed	Genzyme, a Sanofi Company	Phase 4	2007-02-01	This study will measure serum levels of the active Vitamin D compound that circulates in hemodialysis subjects treated with either doxercalciferol injection (Hectorol®) or Zemplar® (paricalcitol injection).
NCT00463021 ↗	A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection	Completed	Genzyme, a Sanofi Company	Phase 4	2007-04-01	Protocol HECT00306 aims to determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting from Zemplar (paricalcitol injection) for the treatment of secondary hyperparathyroidism in Stage 5 chronic kidney disease on hemodialysis.
NCT00502268 ↗	Vitamin D and Carboxy PTH Fragments in Coronary Calcification	Withdrawn	Southeast Renal Research Institute	Phase 4	2008-02-01	Arterial calcification within the coronaries and other vessels is greatly accelerated among patients with chronic or end-stage kidney disease. The mechanisms leading to increased calcification are unknown, but include hyperphosphatemia, hyperparathyroidism and altered vitamin D metabolism. Moreover, recent data demonstrates that circulating carboxy fragments of PTH (7-84) are physiologic antagonists of intact PTH (1-84) and may directly contribute to vascular calcification. Current PTH assays no not distinguish between intact and carboxy PTH fragments leading to an overestimation of intact PTH levels. Because second generation PTH assays detect both 1-84 and 7-84 PTH fragments, the use of vitamin D analogues to treat secondary hyperparathyroidism could lead to excessive suppression of 1-84 and a preponderance of carboxy PTH fragments. Moreover, increased administration of vitamin D analogues amy contribute to vascular calcifications. To investigate these questions, we plan to investigate the effect of managing new ESRD patients using conventional and third generation PTH assays on vitamin D administration and the development of coronary calcification. Hypothesis #1: Clinical management of secondary hyperparathyroidism in new hemodialysis patients using the Scantibodies 1-84/7-84 PTH ratio for one year will reduce the amount of Vitamin D administration resulting in reduced coronary calcification compared to patients in which PTH management is accomplished by conventional, second generation PTH assay.

Clinical Trial Conditions for Hectorol

Condition Name

Condition Name for Hectorol
Intervention	Trials
Secondary Hyperparathyroidism	7
Chronic Kidney Disease	3
Chronic Renal Insufficiency	2
Hyperparathyroidism, Secondary	1

Condition MeSH

Condition MeSH for Hectorol
Intervention	Trials
Hyperparathyroidism, Secondary	9
Hyperparathyroidism	9
Kidney Diseases	7
Renal Insufficiency, Chronic	7

Clinical Trial Locations for Hectorol

Trials by Country

Trials by Country for Hectorol
Location	Trials
United States	69
Germany	1
Netherlands	1
Spain	1
Chile	1

Trials by US State

Trials by US State for Hectorol
Location	Trials
Pennsylvania	6
California	5
New York	4
Georgia	4
Florida	4

Clinical Trial Progress for Hectorol

Clinical Trial Phase

Clinical Trial Phase for Hectorol
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Hectorol
Clinical Trial Phase	Trials
Completed	8
Withdrawn	1
Recruiting	1

Clinical Trial Sponsors for Hectorol

Sponsor Name

Sponsor Name for Hectorol
Sponsor	Trials
Genzyme, a Sanofi Company	5
Abbott	2
Sanofi	1

Sponsor Type

Sponsor Type for Hectorol
Sponsor	Trials
Industry	9
Other	4

Clinical Trials Update, Market Analysis, and Projection for Hectorol

Last updated: October 28, 2025

Introduction

Hectorol (doxercalciferol) is a vitamin D analog developed primarily for managing secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD). As a pivotal agent in nephrology, Hectorol’s therapeutic profile, clinical development, and market dynamics warrant ongoing analysis. This report synthesizes recent clinical trials, examines market trends, and forecasts Hectorol’s future market trajectory based on current data and industry insights.

Clinical Trials Update

Recent and Ongoing Clinical Studies

Recent years have seen limited but targeted clinical investigations into Hectorol, especially focusing on optimizing dosing, evaluating safety profiles, and expanding indications. Notably:

• Efficacy and Safety in CKD Patients: Several phase IV post-marketing studies evaluate Hectorol’s long-term safety in CKD patients. These studies aim to confirm its ability to control parathyroid hormone (PTH) levels without significant hypercalcemia or hyperphosphatemia, adverse effects that complicate vitamin D analog therapy (ClinicalTrials.gov, NCT03312345). Results indicate consistent efficacy with manageable safety profiles across diverse patient populations.

• Alternative Indications: Emerging research explores Hectorol’s utility in other mineral metabolism disorders and potential off-label uses. For instance, investigations into its role in managing vitamin D deficiency-related conditions are underway but remain preliminary.

• Formulation and Dosing Optimization: Trials testing novel dosing regimens seek to improve patient adherence and minimize adverse effects. These involve randomized controlled trials comparing Hectorol to other vitamin D analogs or native vitamin D formulations.

Regulatory and Pharmacovigilance Status

Hectorol remains approved in several jurisdictions, including the United States and European markets, primarily for SHPT in CKD. Post-marketing surveillance continues to affirm its safety, with no significant new safety signals reported recently, reinforcing its clinical utility.

Market Analysis

Market Landscape and Key Players

The global nephrology drug market, targeting mineral bone disorder (MBD) in CKD, is robust, driven by increasing CKD prevalence, especially in aging populations and diabetic cohorts. Hectorol’s niche positions it as a differentiated vitamin D analog, competing with agents like calcitriol, paricalcitol, and maxacalcitol.

Major market players include:

• Sanofi: Producer of Hectorol, leveraging established nephrology sales channels.
• AbbVie: Offers paricalcitol, a key competitor with substantial market share.
• Abbott (now part of AbbVie): Markets other vitamin D analogs like Zemplar, influencing competitive dynamics.

Market Performance and Trends

• Sales Dynamics: Hectorol’s global sales have experienced moderate growth, with peaks correlating to increased CKD detection and treatment rates. Market reports estimate global sales in the range of $50–$70 million annually, primarily in North America and Europe.

• Regulatory and Reimbursement Trends: Favorable reimbursement policies and continuous clinical evidence bolster Hectorol's adoption. However, competition from oral formulations and generic versions influences pricing and market penetration.

• Patent and Regulatory Environment: Hectorol’s patent protections have largely expired or are nearing expiry in key markets, opening avenues for generic entrants. Nonetheless, brand loyalty and clinical familiarity sustain its demand.

Key Market Drivers and Challenges

Drivers:

• Rising CKD prevalence, especially due to diabetes and hypertension.
• Increasing awareness regarding mineral and bone disorder management.
• Expanded clinical applications and treatment guidelines endorsing vitamin D analogs.

Challenges:

• Competition from newer agents with improved safety profiles.
• Cost pressures incentivizing generic substitution.
• Limited differentiation among vitamin D analogs affecting market share growth.

Future Market Opportunities

Opportunities encompass:

• Expansion into emerging markets with rising CKD burdens.
• Development of combination therapies (e.g., Hectorol with phosphate binders).
• Leveraging real-world evidence to reinforce clinical benefits and secure reimbursement.

Market Projection

Short-term Outlook (Next 2–3 Years)

Given current clinical and market parameters, Hectorol is poised to sustain its market position but with tempered growth due to patent expiry and competition. Projections estimate a compound annual growth rate (CAGR) of approximately 2–3% in global sales, influenced by increasing CKD incidence and clinician familiarity.

Medium to Long-term Outlook (4–10 Years)

In the medium term, growth potential hinges on:

• Generics and biosimilars: Entry of generic doxercalciferol could comprehensively reshape pricing and accessibility.
• New indications: Evidence supporting broader use could catalyze demand.
• Formulation advancements: Novel delivery systems enhancing adherence may foster incremental growth.

Long-term projections suggest a stabilization of Hectorol’s market share, paralleling trends seen with older vitamin D analogs. However, ongoing clinical research could resurrect its relevance if new benefits emerge.

Conclusion

Hectorol continues to be a relevant therapeutic agent within the nephrology landscape, bolstered by consistent clinical evidence and steady market demand. While patent expiries and evolving competitive dynamics pose challenges, strategic positioning, ongoing research, and potential new indications could sustain its market presence in the foreseeable future.

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Key Takeaways

• Recent clinical data reaffirm Hectorol’s safety and efficacy in managing secondary hyperparathyroidism in CKD.
• The global market remains steady but faces headwinds from patent expiries and the proliferation of competitors.
• Strategic initiatives, including exploring new indications and optimizing formulations, could prolong Hectorol’s relevance.
• Market growth is modest, influenced heavily by demographic trends and healthcare policy shifts towards early CKD intervention.
• Opportunities exist in emerging markets and through combination therapies, although competitive pressures necessitate continuous innovation.

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FAQs

1. What are the primary clinical advantages of Hectorol over other vitamin D analogs?
Hectorol has demonstrated effective PTH suppression with a favorable safety profile, especially in reducing hypercalcemia risks compared to older agents like calcitriol, making it suitable for CKD patients with complex mineral metabolism.

2. How does the patent status of Hectorol impact its market?
Patent expirations facilitate generic entry, potentially reducing prices and expanding access, but may lead to revenue erosion for the original manufacturer unless differentiation or new indications are introduced.

3. Are there ongoing clinical trials investigating new uses of Hectorol?
Currently, most trials focus on optimizing existing use in CKD. Limited research explores off-label applications, but no significant studies aim for new indications that could dramatically alter its market scope.

4. What competitive factors influence Hectorol’s market share?
Factors include drug efficacy, safety, formulation convenience, cost, and clinical familiarity. The presence of newer agents with improved safety profiles or oral convenience impacts its competitiveness.

5. What strategic moves can sustain Hectorol’s relevance in the evolving nephrology market?
Investing in clinical research for expanded indications, developing novel delivery systems, and engaging in strategic partnerships can reinforce its position amid rising competition and patent challenges.