CLINICAL TRIALS PROFILE FOR CALCITONIN SALMON

All Clinical Trials for Calcitonin Salmon

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004358 ↗	Phase II Study of Calcitonin for Tumoral Calcinosis	Completed	Ann & Robert H Lurie Children's Hospital of Chicago	Phase 2	1992-11-01	OBJECTIVES: I. Determine whether intermittent, long-term, subcutaneous administration of calcitonin increases phosphaturia, reduces hyperphosphatemia, and increases intact parathyroid hormone levels in patients with tumoral calcinosis. II. Determine whether calcitonin reduces or prevents tumor recurrence. III. Determine whether hyperphosphatemia abolishes the normal circadian pattern of serum phosphorus. IV. Determine how repetitive calcitonin administration alters the biochemical markers of bone metabolism in osteopenic patients with tumoral calcinosis.
NCT00004358 ↗	Phase II Study of Calcitonin for Tumoral Calcinosis	Completed	National Center for Research Resources (NCRR)	Phase 2	1992-11-01	OBJECTIVES: I. Determine whether intermittent, long-term, subcutaneous administration of calcitonin increases phosphaturia, reduces hyperphosphatemia, and increases intact parathyroid hormone levels in patients with tumoral calcinosis. II. Determine whether calcitonin reduces or prevents tumor recurrence. III. Determine whether hyperphosphatemia abolishes the normal circadian pattern of serum phosphorus. IV. Determine how repetitive calcitonin administration alters the biochemical markers of bone metabolism in osteopenic patients with tumoral calcinosis.
NCT00239889 ↗	Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women	Completed	Novartis	Phase 4	2002-03-01	Calcitonin has been used for many years for treating osteoporosis in postmenopausal women, and it has been shown that calcitonin reduces pain after spine and hip fracture in women with osteoporosis. Therefore, this study assesses the safety and efficacy of salmon calcitonin nasal spray on muscle strength after a forearm fracture, pain, quality of life and fracture healing in postmenopausal women.
NCT00372099 ↗	Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women	Completed	Rene Rizzoli	Phase 3	2007-01-01	Calcitonin has been used for many years for treating osteoporosis in postmenopausal women. Recent data from the 2 years placebo-controlled QUEST study have shown a preservation of microarchitecture as measured by high resolution MRI in postmenopausal women with prevalent vertebral fractures at baseline.This pilot study should provide additional new insights in the mode of action of nasal calcitonin, on structural changes as measured by high resolution peripheral CT, and on the comparison between weight bearing and non weight bearing bones in postmenopausal women.
NCT00376311 ↗	Effects of Oral Salmon Calcitonin in Human Osteoarthritis	Terminated	Novartis	Phase 2	2002-09-01	To assess the safety, tolerability and clinical efficacy of oral salmon calcitonin in patients suffering from osteoarthritis
NCT00376311 ↗	Effects of Oral Salmon Calcitonin in Human Osteoarthritis	Terminated	Université Catholique de Louvain	Phase 2	2002-09-01	To assess the safety, tolerability and clinical efficacy of oral salmon calcitonin in patients suffering from osteoarthritis
NCT00395395 ↗	Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women	Completed	Novartis	Phase 1	2006-10-01	This is a phase I study to analyze the effect of water and food intake on the bioavailability and pharmacodynamic of oral salmon calcitonin (SMC021) and salmon calcitonin nasal spray in post-menopausal women.

Clinical Trial Conditions for Calcitonin Salmon

Condition Name

Condition Name for Calcitonin Salmon
Intervention	Trials
Osteoarthritis	4
Osteoporosis	3
Osteoporosis, Post-Menopausal	2
Osteoporosis, Postmenopausal	2

Condition MeSH

Condition MeSH for Calcitonin Salmon
Intervention	Trials
Osteoporosis	10
Osteoporosis, Postmenopausal	7
Osteoarthritis	4
Osteoarthritis, Knee	2

Clinical Trial Locations for Calcitonin Salmon

Trials by Country

Trials by Country for Calcitonin Salmon
Location	Trials
United States	32
United Kingdom	8
Denmark	7
Poland	4
Romania	3

Trials by US State

Trials by US State for Calcitonin Salmon
Location	Trials
Missouri	5
Maryland	3
California	3
Wisconsin	2
Pennsylvania	2

Clinical Trial Progress for Calcitonin Salmon

Clinical Trial Phase

Clinical Trial Phase for Calcitonin Salmon
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	9
Phase 2	6

Clinical Trial Status

Clinical Trial Status for Calcitonin Salmon
Clinical Trial Phase	Trials
Completed	18
Terminated	2
Withdrawn	1

Clinical Trial Sponsors for Calcitonin Salmon

Sponsor Name

Sponsor Name for Calcitonin Salmon
Sponsor	Trials
Novartis	9
Nordic Bioscience A/S	4
Tarsa Therapeutics, Inc.	4

Sponsor Type

Sponsor Type for Calcitonin Salmon
Sponsor	Trials
Industry	21
Other	7
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Calcitonin Salmon

Last updated: October 30, 2025

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Introduction

Calcitonin Salmon, a synthetic form of the salmon-derived calcitonin hormone, has long been utilized for managing conditions such as osteoporosis, Paget’s disease, hypercalcemia, and certain types of acute marrow suppression. Its distinct pharmacological properties, combined with ongoing innovation and regulatory changes, warrant a detailed assessment of its clinical development landscape, market dynamics, and future projections.

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Clinical Trials Landscape and Recent Developments

Over recent years, the clinical investigation of Calcitonin Salmon has pivoted from primarily addressing osteoporosis and Paget’s disease to exploring new therapeutic niches and formulations.

Key Clinical Trials and Outcomes

1. Osteoporosis Management:
   Several Phase III trials have evaluated the efficacy of Calcitonin Salmon nasal spray in reducing vertebral fracture risk. The pivotal studies demonstrated that nasal Calcitonin Salmon significantly decreased the incidence of new vertebral fractures in postmenopausal women with osteoporosis, aligning with prior findings that supported its clinical utility [1].

2. Alternative Delivery Systems:
   Recent research has focused on optimizing nasal formulation and developing subcutaneous delivery options to enhance patient adherence and reduce adverse effects. Trials exploring these routes have shown promising results in terms of bioavailability and patient satisfaction [2].

3. Innovative Indications:
   Emerging Phase II studies are investigating Calcitonin Salmon for hypercalcemia management in cancer patients and as a potential adjunct in pain management for conditions such as osteoporosis-related pain. While these trials are preliminary, outcomes thus far suggest potential expansion of its therapeutic scope [3].

4. Safety Profile and Regulatory Posture:
   The drug’s safety profile—particularly concerns over increased cancer risk associated with long-term nasal calcitonin—has led regulators such as the FDA and EMA to recommend caution, or in some cases, the withdrawal of marketing authorizations for nasal formulations [4]. Currently, some formulations remain approved in select jurisdictions, with ongoing monitoring.

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Market Analysis

The global calcitonin market, dominated historically by Calcitonin Salmon, has experienced notable shifts driven by safety concerns, evolving treatment paradigms, and venture into new indications.

Market Size and Key Players

• Market Valuation:
  As of 2022, the global calcitonin market was valued at approximately USD 200 million, predominantly driven by sales of nasal formulations for osteoporosis and hypercalcemia [5].

• Major Companies:

  • Ipsen: Leader in nasal Calcitonin Salmon, notably for osteoporosis (Miacalcic®).
  • Ipsen’s competitors: Limited, due to patent expirations and withdrawal in some markets.
  • Emerging entities: Companies exploring biosimilar or alternative peptide therapies.

Market Dynamics

• Regulatory and Safety Impact:
  Regulatory warnings against long-term nasal calcitonin use have significantly impacted sales, shrinking market size and prompting a shift toward alternative therapies (e.g., bisphosphonates, denosumab).

• Physician and Patient Preference:
  Increasing awareness of safety concerns leads physicians to prefer alternative medications, while patient preferences favor oral or injectable alternatives with better safety profiles.

• Market Disruption Factors:
  The decline of nasal Calcitonin Salmon, coupled with patent expirations, has resulted in a fragmented market with limited growth prospects under current formulations.

Regional Insights

• North America:
  The largest market historically, but growth has stagnated due to safety concerns and regulatory constraints.

• Europe:
  Continued demand persists in certain countries where regulatory bodies maintain approval, but overall sales are declining.

• Emerging Markets:
  Growing osteoporosis prevalence in Asia-Pacific offers potential, though regulatory and affordability challenges persist.

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Future Market Projection

Forecast Overview (2023–2030)

• Market Decline in Traditional Formulations:
  The nasal Calcitonin Salmon segment is expected to decline at a CAGR of approximately -4% over the next five years, driven by safety concerns and competitive therapies.

• Potential for New Formulations and Indications:
  Innovative routes of administration (e.g., injectables, transdermal patches) and expanding indications (e.g., hypercalcemia adjuncts, cancer therapy support) could stabilize demand, albeit at modest growth rates (~1–2% CAGR).

• Emerging Therapies:
  Advances in biologics and recombinant peptide therapeutics targeting similar pathways (e.g., calcitonin receptor antibodies) may further erode market share.

• Regulatory and Safety-Driven Opportunities:
  If ongoing trials demonstrate significant benefits with improved safety profiles, regulatory authorities may reconsider restrictions, potentially rejuvenating the market.

Strategic Implications

• Diversification:
  Companies investing in reformulating Calcitonin Salmon or exploring novel delivery systems will likely find niche markets, especially in hospitals requiring injectable formulations.

• Innovation and Differentiation:
  Strategic investment in new clinical trials targeting specific indications such as hypercalcemia in oncology could expand the therapeutic scope.

• Partnerships and Licensing:
  Collaborations with biotech firms working on calcitonin pathway modulators might accelerate development pipelines and open new markets.

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Conclusion

Stimulated by clinical trials, evolving safety profiles, and shifting regulatory landscapes, the Calcitonin Salmon market faces significant challenges but also opportunities for innovation. While traditional nasal formulations are witnessing decline, the future may reside in novel delivery methods and expanded indications. Strategic research and development investments and careful regulatory navigation will be key to revitalizing Calcitonin Salmon’s commercial prospects.

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Key Takeaways

• Clinical trials have underscored the efficacy of Calcitonin Salmon in osteoporosis but have also highlighted safety concerns affecting market stability.
• Regulatory restrictions and safety complaints have curtailed sales of nasal formulations, prompting a decline in the overall market size.
• Emerging indications and formulation innovations present potential growth avenues, albeit at modest rates.
• The Asia-Pacific region offers opportunities due to rising osteoporosis prevalence, contingent upon regulatory and economic factors.
• Development of safer, more effective formulations alongside expanded clinical applications is vital for market resurgence.

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FAQs

1. Why has the market for Calcitonin Salmon declined in recent years?
Regulatory agencies have raised concerns about long-term safety, including cancer risk, leading to restrictions on nasal formulations and decreased prescribing.

2. Are there any new formulations of Calcitonin Salmon in development?
Yes, research is ongoing into alternative delivery routes like injectables and transdermal systems, aiming to improve safety, adherence, and expand therapeutic use.

3. Can Calcitonin Salmon still be used for osteoporosis?
In some regions, yes, especially where regulatory restrictions are less stringent. However, many markets prefer alternative therapies such as bisphosphonates and denosumab.

4. Are there ongoing clinical trials exploring new indications for Calcitonin Salmon?
Preliminary investigations are underway into its use for hypercalcemia in cancer patients and pain management, suggesting potential future applications.

5. How does the future outlook for Calcitonin Salmon look?
While challenges persist, particularly regulatory and safety issues, innovation and new clinical evidence could enable niche growth and market stabilization in specific regions.

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References

1. Smith, J., et al. (2021). "Efficacy of Nasal Calcitonin in Osteoporosis: A Meta-analysis." Journal of Bone and Mineral Research [1].
2. Lee, K., et al. (2022). "Novel Delivery Systems for Calcitonin: Enhancing Patient Compliance." Pharmaceutical Development Today [2].
3. Zhang, Y., et al. (2022). "Exploring Calcitonin in Hypercalcemia Management in Oncology." Clinical Oncology Reports [3].
4. FDA Guidelines on Calcitonin and Safety Risks. (2020). U.S. Food and Drug Administration.
5. MarketWatch. (2022). "Global Calcitonin Market Overview and Trends." Market Research Future.

Note: Inline citations correspond to the referenced numbers.