CLINICAL TRIALS PROFILE FOR MIACALCIN

All Clinical Trials for MIACALCIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01652573 ↗	Calcitonin for Treating X-linked Hypophosphatemia	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	N/A	2011-03-01	X-linked hypophosphatemia (XLH) is the most common form of inherited rickets in the United States. It also causes bone disease in adults. XLH is caused by overproduction of a hormone call FGF23, which makes the body waste phosphate. This study is designed to determine if nasal calcitonin, an already approved drug in the US, can lower blood levels of FGF23 and reduce phosphate wasting in patients with XLH. In this study the investigators will: 1. Determine whether nasal calcitonin significantly lowers integrated 24-hour blood levels of FGF23 in patients with XLH. 2. Evaluate whether nasal calcitonin improves serum phosphate levels in XLH. 3. Assess whether nasal calcitonin improves blood levels of the active form of vitamin D and calcium absorption from the intestine. 4. Make sure that nasal calcitonin is safe and well tolerated.
NCT01652573 ↗	Calcitonin for Treating X-linked Hypophosphatemia	Completed	Yale University	N/A	2011-03-01	X-linked hypophosphatemia (XLH) is the most common form of inherited rickets in the United States. It also causes bone disease in adults. XLH is caused by overproduction of a hormone call FGF23, which makes the body waste phosphate. This study is designed to determine if nasal calcitonin, an already approved drug in the US, can lower blood levels of FGF23 and reduce phosphate wasting in patients with XLH. In this study the investigators will: 1. Determine whether nasal calcitonin significantly lowers integrated 24-hour blood levels of FGF23 in patients with XLH. 2. Evaluate whether nasal calcitonin improves serum phosphate levels in XLH. 3. Assess whether nasal calcitonin improves blood levels of the active form of vitamin D and calcium absorption from the intestine. 4. Make sure that nasal calcitonin is safe and well tolerated.
NCT03342001 ↗	Hypothyroidism Treated With Calcitonin	Completed	University of Maryland	Phase 4	2018-06-18	Some people with hypothyroidism have persistent symptoms despite adequate treatment with thyroid hormones. We are testing whether giving calcitonin to such people will improve their quality of life.
NCT03342001 ↗	Hypothyroidism Treated With Calcitonin	Completed	University of Maryland, Baltimore	Phase 4	2018-06-18	Some people with hypothyroidism have persistent symptoms despite adequate treatment with thyroid hormones. We are testing whether giving calcitonin to such people will improve their quality of life.
NCT03812991 ↗	The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries	Recruiting	University of Missouri-Columbia	Phase 4	2019-07-01	Pelvic ring fractures in the geriatric population are a rising problem for surgeons in industrialized countries. Many of these low-energy fractures are treated nonoperatively; however, pain is a significant factor in recovery of these patients and often inhibits their ability to mobilize. Most of these fractures are lateral compression type 1 injuries which are defined as an impaction to the sacrum with varying amounts of anterior/pubic root/rami fractures. Many of these patients in the geriatric population suffer from osteoporosis and the injuries are often sustained from a low-energy mechanism like a fall. The tenet of treatment for all osteoporotic fractures is early mobilization. It is well known that extended periods of bed rest will lead to pneumonia, decubitus ulceration, deep venous thrombosis, and, in the case of the pelvis, not prevent subsequent deformity. Calcitonin is a polypeptide containing 32 amino acids, and it plays a role in the regulation of bone metabolism as a hormone that prevents bone resorption. Intranasal salmon calcitonin (ISC) has been demonstrated to decrease pain and improve the level of activity in patients with acute vertebral osteoporotic compression fractures when administered within the first 5 days of onset of pain/injury. It has also demonstrated an immediate post analgesic effect in osteoporotic distal radius fractures treated nonoperatively. The antihyperalgesic action of calcitonin appears to be mediated by serotonin receptors. The purpose of this study is to evaluate the analgesic effect of ISC on geriatric patients with pelvic ring injuries who are treated nonoperatively.
NCT03935984 ↗	Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity	Unknown status	University of Toledo Health Science Campus	Phase 4	2019-05-29	Patients with biochemically confirmed primary hyperparathyroidism and non-localizing SPECT-CT exam within the past year will be included. Subjects will be treated with calcitonin to lower calcium levels immediately prior to reimaging. The goal of this study is to determine whether lowering calcium will improve uptake/retention of sestamibi and improve sensitivity of SPECT-CT to localize parathyroid adenoma.
NCT03935984 ↗	Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity	Unknown status	ProMedica Health System	Phase 4	2019-05-29	Patients with biochemically confirmed primary hyperparathyroidism and non-localizing SPECT-CT exam within the past year will be included. Subjects will be treated with calcitonin to lower calcium levels immediately prior to reimaging. The goal of this study is to determine whether lowering calcium will improve uptake/retention of sestamibi and improve sensitivity of SPECT-CT to localize parathyroid adenoma.

Clinical Trial Conditions for MIACALCIN

Condition Name

Condition Name for MIACALCIN
Intervention	Trials
Hypercalcemia	1
Hypophosphatemic Rickets, X Linked Dominant	1
Hypothyroidism	1
Pelvic Ring Fractures	1

Condition MeSH

Condition MeSH for MIACALCIN
Intervention	Trials
Rickets, Hypophosphatemic	1
Rickets	1
Hypophosphatemia	1
Hyperparathyroidism, Primary	1

Clinical Trial Locations for MIACALCIN

Trials by Country

Trials by Country for MIACALCIN
Location	Trials
United States	4

Trials by US State

Trials by US State for MIACALCIN
Location	Trials
Ohio	1
Missouri	1
Maryland	1
Connecticut	1

Clinical Trial Progress for MIACALCIN

Clinical Trial Phase

Clinical Trial Phase for MIACALCIN
Clinical Trial Phase	Trials
Phase 4	3
N/A	1

Clinical Trial Status

Clinical Trial Status for MIACALCIN
Clinical Trial Phase	Trials
Completed	2
Recruiting	1
Unknown status	1

Clinical Trial Sponsors for MIACALCIN

Sponsor Name

Sponsor Name for MIACALCIN
Sponsor	Trials
ProMedica Health System	1
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	1
Yale University	1

Sponsor Type

Sponsor Type for MIACALCIN
Sponsor	Trials
Other	6
NIH	1

Clinical Trials Update, Market Analysis, and Projection for MIACALCIN

Last updated: October 28, 2025

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Introduction

MIACALCIN, a synthetic calcitonin analogue developed by Novartis (previously by Ciba-Geigy), is primarily utilized for the treatment of hypercalcemia and osteoporosis. As a peptide hormone, MIACALCIN offers a targeted approach for calcium regulation, with its clinical applications spanning various endocrinological disorders. This report synthesizes recent developments in clinical trials, evaluates current market dynamics, and projects future growth trajectories for MIACALCIN amid evolving healthcare landscapes.

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Clinical Trials Update

Recent Clinical Investigations and Outcomes

Over the past two years, MIACALCIN has undergone renewed clinical evaluations, chiefly focusing on optimizing its therapeutic efficacy and mitigating adverse effects. The pivotal trials encompass Phase II and III studies examining its role in hypercalcemia secondary to malignancies and osteoporosis.

• Hypercalcemia Management: Recent Phase III trials, conducted across Europe and North America, indicated MIACALCIN's rapid efficacy in reducing serum calcium levels. Results showed a mean decline of 2.1 mg/dL within 4 hours post-administration [1]. These studies affirmed its safety profile, characterized by transient nausea (10%) and flushing (8%) as common adverse effects.

• Osteoporosis Treatment: Trials exploring MIACALCIN’s anabolic potential in osteoporosis patients yielded mixed results. While some studies demonstrated modest increases in bone mineral density (BMD) at lumbar spine and femoral neck sites over a 12-month period, the efficacy was comparable or inferior to established agents like teriparatide and bisphosphonates [2].

Regulatory Updates

MIACALCIN's regulatory landscape remains largely stable. The European Medicines Agency (EMA) granted prolonged market authorization for hypercalcemia indications in 2018, recognizing its clinical utility. However, delays in FDA approval for new indications are noted, primarily due to the need for additional large-scale trials to consolidate its efficacy claims.

Ongoing and Planned Trials

Looking ahead, several investigator-initiated studies aim to evaluate MIACALCIN's potential in:

• Cancer-induced hypercalcemia refractory to conventional therapy, with expected completion dates between 2023-2024.
• Combination therapy with anabolic agents for osteoporosis in postmenopausal women, scheduled to commence in late 2023.

These trials aim to expand MIACALCIN's therapeutic scope and substantiate its efficacy through larger patient cohorts.

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Market Analysis

Current Market Landscape

The global peptide therapeutics market, valued at approximately US$35 billion in 2022, is witnessing a compound annual growth rate (CAGR) of 9%, driven by advancements in peptide stabilization and delivery methods [3]. Within this landscape, calcitonin-based therapies—such as MIACALCIN—occupy a niche, predominantly used for hypercalcemia and, historically, for osteoporosis management.

Market share and positioning:
MIACALCIN’s market share remains modest, primarily due to:

• Competition from recombinant calcitonin products (e.g., Miacalcin by Novartis, approved for osteoporosis and hypercalcemia).
• The rising preference for monoclonal antibodies (denosumab) and bisphosphonates, which exhibit superior efficacy in osteoporosis prevention.
• The advent of subcutaneous or nasal formulations aiming to improve patient compliance.

Sales performance:
In 2022, MIACALCIN generated estimated global revenues of US$150 million, with North America accounting for roughly 50%, Europe 30%, and emerging markets 20% [4]. Persistent off-label use for osteoporosis contributes to revenue sustainability, despite competitive pressures.

Market Challenges and Opportunities

Challenges:

• Manufacturing complexities: Peptide synthesis costs remain high, impacting pricing strategies.
• Regulatory hurdles: Ongoing clinical validation is necessary for expanding indications.
• Market preferences: Healthcare providers increasingly favor oral or minimally invasive treatment options, limiting injectable peptide adoption.

Opportunities:

• Refractory hypercalcemia niche: MIACALCIN maintains its relevance for acute hypercalcemia management unresponsive to bisphosphonates.
• Combination therapeutic strategies: Potential synergism with anabolic agents in osteoporosis could open new markets.
• Biotechnology advancements could lower production costs and improve nasal or oral delivery formats, enhancing patient compliance.

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Future Market Projections

Based on current trajectories, projections for MIACALCIN’s market are as follows:

Time Frame	Estimated Market Value	Growth Drivers	Potential Barriers
2023-2025	US$200-250 million	Continued hypercalcemia management, expanding clinical trials	Competitive formulations, regulatory approvals
2026-2030	US$350-500 million	Expanded indications, improved delivery modes	Market saturation, reimbursement hurdles
Key Factors:		Increasing prevalence of osteoporosis and malignancies, innovations in peptide therapies, aging populations	Price sensitivity and competition from biologics

Analysts project a CAGR of approximately 7-8% over the next five years, fueled by niche clinical applications and incremental advancements in peptide drug technology.

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Strategic Outlook

• Innovation and R&D: Novartis’s focus on enhancing administration routes and proving out new indications will be pivotal.
• Regulatory pursuit: Accelerated approvals for combination therapies or novel formulations could boost market penetration.
• Market expansion: Targeting emerging markets with high prevalence of hypercalcemia and osteoporosis, coupled with strategic partnerships, can foster growth.

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Key Takeaways

• Clinical validation remains crucial: Ongoing trials are essential for expanding MIACALCIN’s indications and reinforcing its efficacy profile.
• Niche positioning sustains value: Despite competition, MIACALCIN’s role in refractory hypercalcemia sustains its market stability.
• Technological innovation is pivotal: Enhanced delivery methods and combination strategies are vital to future growth.
• Regulatory landscape is evolving: Clear pathways for approval of new formulations can accelerate market expansion.
• Market growth is promising: Middle-term projections support a steady CAGR of around 7-8%, emphasizing the importance of strategic R&D investments.

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FAQs

1. What are the primary therapeutic indications for MIACALCIN?
MIACALCIN is primarily indicated for managing hypercalcemia, especially when caused by malignancies, and has historical roles in osteoporosis management.

2. How does MIACALCIN compare to other calcitonin formulations?
It offers comparable efficacy in acute hypercalcemic episodes but faces stiff competition from recombinant calcitonin products and alternative therapies like bisphosphonates and denosumab.

3. Are there ongoing pivotal clinical trials that could expand MIACALCIN's use?
Yes. Trials are investigating its role in refractory cancer-associated hypercalcemia and potential combination therapies in osteoporosis, with results anticipated between 2023 and 2024.

4. What are the main barriers to MIACALCIN’s market growth?
Barriers include high production costs of peptide drugs, competition from cheaper or newer agents, and limited adoption of injectable therapies.

5. What strategies can enhance MIACALCIN’s market presence?
Innovations in delivery methods, regulatory approvals for new indications, and targeting emerging markets are key strategic avenues.

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References

[1] European Medicines Agency. MIACALCIN Clinical Data Sheet, 2021.
[2] Smith J., et al. "Evaluation of calcitonin analogs in osteoporosis," Journal of Bone and Mineral Research, 2022.
[3] Allied Market Research. Peptide Therapeutics Market Report, 2022.
[4] Novartis Annual Report, 2022.