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.
NCT00001304 ↗	Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1991-10-01	This study has been important in establishing synthetic human parathyroid hormone 1-34 (PTH) as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with calcium and calcitriol. Providing synthetic human parathyroid hormone 1-34 (PTH) to patients who are unresponsive to conventional therapy has enabled severe cases of hypoparathyroidism to be managed effectively with the investigational drug, PTH. The primary goals of this study are to (1) provide long-term PTH therapy to patients who do not respond to conventional therapy; (2) understand the long-term effect of therapeutic PTH replacement on kidney function and bone mineral density; (3) study and track linear growth and bone accrual in children with hypoparathyroidism. (4) determine if subjects reach a normal level of peak bone mass and if the timing of this is comparable to normal age-matched healthy controls.
NCT00001416 ↗	Bone Response to Enzyme Replacement in Gaucher's Disease	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	1993-12-01	The purpose of this study is to examine how the skeleton responds to repeated doses of enzyme replacement therapy in patients with type I Gaucher's disease who have had their spleens removed. Gaucher disease is a lysosomal storage disease resulting from glycocerebroside accumulation in macrophages due to a genetic deficiency of the enzyme glucocerebrosidase. It may occur in adults but occurs most severely in infants, in whom cerebroside also accumulates in neurons. Patients with Gaucher's disease experience enlargement of the liver and spleen and bone destruction. The condition is passed from generation to generation through autosomal recessive inheritance. Type I is the most common form. It is a chronic non-neuronopathic form, meaning the disease does not affect nerve cells. The symptoms of type I can appear at any age. In this study patients will be divided into three groups. Each group will receive different doses of enzyme replacement (Ceredase). In addition, two of the three groups will also receive doses of a form of vitamin D (calcitriol). Researchers believe the groups receiving vitamin D will have an improved response as compared to those patients only receiving enzyme replacement. Patients in each group who respond to enzyme replacement with increases in bone density will be compared to the other treatment groups.
NCT00004340 ↗	Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	1995-06-01	OBJECTIVES: I. Evaluate the separate and combined skeletal effects of recombinant human growth hormone (GH) and calcitriol in patients with adynamic renal osteodystrophy. II. Assess whether calcium-regulated changes in parathyroid hormone secretion predict changes in bone formation. III. Characterize the response to GH in cancellous bone and in growth plate cartilage in patients with secondary hyperparathyroidism during calcitriol therapy.
NCT00004340 ↗	Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis	Completed	University of California, Los Angeles	Phase 2	1995-06-01	OBJECTIVES: I. Evaluate the separate and combined skeletal effects of recombinant human growth hormone (GH) and calcitriol in patients with adynamic renal osteodystrophy. II. Assess whether calcium-regulated changes in parathyroid hormone secretion predict changes in bone formation. III. Characterize the response to GH in cancellous bone and in growth plate cartilage in patients with secondary hyperparathyroidism during calcitriol therapy.

Clinical Trial Conditions for CALCITRIOL

Condition Name

Condition Name for CALCITRIOL
Intervention	Trials
Vitamin D Deficiency	12
Prostate Cancer	10
Chronic Kidney Disease	9
Secondary Hyperparathyroidism	8

Condition MeSH

Condition MeSH for CALCITRIOL
Intervention	Trials
Kidney Diseases	32
Renal Insufficiency, Chronic	22
Hyperparathyroidism	16
Hyperparathyroidism, Secondary	15

Clinical Trial Locations for CALCITRIOL

Trials by Country

Trials by Country for CALCITRIOL
Location	Trials
United States	264
Canada	24
China	12
Malaysia	7
Italy	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
PHASE4	1
PHASE2	1
PHASE1	2

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)	9
Novacea	8

Sponsor Type

Sponsor Type for CALCITRIOL
Sponsor	Trials
Other	183
Industry	55
NIH	34

Calcitriol clinical trials update, market analysis, and revenue projection

Last updated: July 28, 2026

Calcitriol (1,25-dihydroxyvitamin D3) is an established active vitamin D therapy with mature commercialization. A clinically oriented IP and regulatory forward view depends on product- and route-specific brands (oral capsules, oral solutions, injectable calcitriol, and topical calcitriol analogs where applicable). Without a defined reference product (and its FDA application number / Orange Book listing), an accurate, launch-timing-quality “clinical trials update” and financial projection by indication cannot be produced.

What is calcitriol’s current clinical development status by indication?

Calcitriol is primarily used for established indications such as secondary hyperparathyroidism in chronic kidney disease (CKD) and disorders of calcium/phosphate metabolism. Clinical activity is generally limited versus earlier eras because calcitriol is off-patent in many markets and faces competition from calcifediol, vitamin D analogs, and calcimimetics in CKD settings.

Which trial endpoints and designs are most common for calcitriol?

Common endpoint families across calcitriol development programs include:

• Serum parathyroid hormone (PTH) change from baseline
• Serum calcium and phosphate control
• Safety endpoints tied to hypercalcemia and hyperphosphatemia
• Dose titration algorithms and sustained PTH normalization

Are there any ongoing phase 2/3 studies for calcitriol specifically?

A complete trial status requires an exact product name, strength, route, and sponsor for registry matching. “Calcitriol” alone spans multiple formulations (capsules, solutions, injection) and multiple ecosystems of use. Without that anchor, any “phase-by-phase” update would risk mixing unrelated products and indications.

How big is the calcitriol market and what drives demand?

Calcitriol demand tracks chronic patient volumes and guideline-driven prescribing patterns for calcium and vitamin D metabolism disorders, with growth influenced by:

• CKD prevalence and dialysis/CKD-MBD management practices
• Shifts in guideline thresholds for PTH targets and treatment intensity
• Formulary adoption and payer controls around cost per controlled patient outcome
• Safety-driven dosing constraints that limit maximal dose utilization

What segments matter most commercially?

Commercial segmentation typically breaks down by:

• Indication: CKD secondary hyperparathyroidism and other calcium metabolism disorders
• Route: oral versus injectable
• Formulation: branded originator versus generics/biosimilars are not directly applicable here, but formulation differences matter
• Geography: pricing pressure in highly genericized markets changes revenue capture

Where does pricing typically land for calcitriol?

Revenue capture for older vitamin D products is generally driven by:

• Generic entry intensity
• Presence of branded formulations in select geographies
• Titration protocols that affect monthly treated days and dose intensity

What revenue projection is realistic for calcitriol through the next 5 years?

A defensible projection requires at least one of:

• a specific branded product’s net sales baseline (or market-wide published figures with citation), and/or
• a mapped forecast by geography, indication, and formulation class.

Without the specific reference product and its commercial baseline, any numeric projection would be non-auditable.

What are the main forecast variables for calcitriol?

• Incidence and prevalence trends for CKD and CKD-MBD
• Penetration of vitamin D analogs (and agents used alongside vitamin D)
• Generic substitution rates and wholesaler pricing spreads
• Regulatory or safety actions affecting labels, dosing caps, or warnings

Which companies sell calcitriol and how competitive is the landscape?

Calcitriol’s competitive environment is shaped by generic manufacturing and distribution scale rather than patent exclusivity in many jurisdictions. Brands vary by country and route.

How do competitors typically position against calcitriol?

• Vitamin D analogs with different calcemic risk profiles or dosing convenience
• Combination management strategies in CKD-MBD that may reduce calcitriol utilization in some cohorts
• Payer-favoring coverage tiers for generics

What “white space” exists for calcitriol?

White space is often formulation driven:

• Alternative delivery systems (where permitted)
• Improved titration ease and reduced monitoring burden
• Patient adherence improvements in oral regimens

What does the FDA regulatory status mean for calcitriol supply and launches?

Calcitriol is an FDA-regulated drug. Competitive entry risk turns on:

• Orange Book listings (assessed via application number, strength, dosage form)
• Patent thickets and whether listed patents are method-of-use, formulation, or composition claims
• Exclusivity expirations tied to application history (not just patents)

What is the Orange Book status of calcitriol?

An Orange Book status requires the specific NDA/ANDA/BLA and dosage form. “Calcitriol” alone maps to multiple products.

What Paragraph IV and settlement risks exist?

Those risks depend on:

• whether a listed patent is subject to Paragraph IV certifications
• whether a 30-month stay or design-around appears in litigation dockets
• whether a settlement locks entry to a specific date or design target

What patents protect calcitriol formulations and methods of use?

For calcitriol, the relevant IP analysis is highly product-specific:

• “calcitriol” can refer to composition-of-matter, formulation, manufacturing method, or method-of-use claims
• injectable versus oral formulations can have different protection patterns
• therapeutic use claims can be narrow, affecting generic entry if a patent is still listed and enforceable

How strong is the patent estate for calcitriol?

Strength depends on:

• active, enforceable patents listed in the Orange Book
• litigation outcomes and stipulations
• whether any patents are still within enforceable term or subject to terminal disclaimers

What generic entry risks exist for calcitriol products?

Generic entry risk is driven by Orange Book listing status and litigation posture:

• If no enforceable listed patents remain, entry timing is primarily regulatory readiness and manufacturing scale
• If patents remain, Paragraph IV and settlements can delay launch or require label carve-outs

What is the typical launch window for generic calcitriol?

A generic timeline generally depends on:

• ANDA approval readiness and labeling
• patent litigation outcomes and whether 180-day exclusivity is claimed
• manufacturing validation timelines

How does calcitriol compare with calcifediol, paricalcitol, and other vitamin D therapies?

Market substitution is indication-dependent:

• CKD-MBD patients may be managed with a range of vitamin D therapies and adjunct classes
• clinical endpoints in practice tend to be PTH suppression with calcium control

What clinical differentiators are usually used in coverage decisions?

• PTH-lowering efficacy
• hypercalcemia and hyperphosphatemia risk
• dose frequency and titration burden
• patient subgroups and comorbidity fit

What clinical trial updates matter for near-term market shifts?

Near-term shifts typically require one of:

• label expansions or new dosing regimens
• head-to-head efficacy/safety evidence that changes guideline or payer behavior
• safety signals that restrict use or change monitoring intensity

What would indicate meaningful momentum for calcitriol?

• FDA label changes tied to expanded indications, route changes, or dosing algorithms
• phase 3 results with clinically differentiated safety outcomes versus alternatives
• published pharmacoeconomic data affecting formulary tiering

Key Takeaways

• Calcitriol is a mature therapy with commercialization driven more by patient volume and prescribing practice than by new clinical development.
• A credible “clinical trials update” and “revenue projection” requires a specific calcitriol product (route, strength, brand or application) because trials, Orange Book listings, and competitive exposure differ by formulation.
• Market growth is most sensitive to CKD prevalence dynamics and competitive substitution by other vitamin D therapies and CKD-MBD management strategies.
• Patent and generic entry risks are determined by Orange Book listing status per specific NDA/ANDA and dosage form, not by “calcitriol” generically.

FAQs

1. Which FDA-approved calcitriol formulations have the highest generic substitution risk?
2. Do calcitriol clinical outcomes differ meaningfully between oral capsules and injectable forms in CKD-MBD?
3. What Orange Book patents most often block generic calcitriol entry, and are they method-of-use or formulation claims?
4. How do payer policies typically compare calcitriol versus vitamin D analogs in CKD secondary hyperparathyroidism?
5. What safety monitoring requirements for calcitriol most influence adherence and dose titration in real-world practice?

References

No sources were provided in the prompt, and no citations can be generated without verifiable FDA/registry/market data tied to a specific calcitriol product and market definition.