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Osteobios (CALCITONIN)
Calcitonin salmon acts as a calcitonin receptor agonist, primarily affecting bone, with additional effects on the kidneys and gastrointestinal tract.
Calcitonin (Osteobios), marketed by Sanofi Aventis US, is a calcitonin receptor agonist primarily indicated for symptomatic Paget's disease of bone. The drug's key strength lies in its well-established mechanism of action and its current market presence, with a key composition patent expiring in 2028. The primary risk is the lack of significant revenue data and key trial results, which may limit its competitive edge against other treatments.
At a glance
| Generic name | CALCITONIN |
|---|---|
| Sponsor | Sanofi Aventis Us |
| Drug class | Calcitonin [EPC] |
| Target | calcitonin receptor |
| Modality | Recombinant protein |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
Calcitonin salmon is a calcitonin receptor agonist that mainly influences bone, though it also affects the kidneys and gastrointestinal tract. It has similar actions to mammalian calcitonins but is more potent and has a longer duration of action. Its exact role in bone physiology is not fully understood, but receptors have been found in osteoclasts and osteoblasts.
Approved indications
- Symptomatic Paget's disease of bone
- Hypercalcemia
- Postmenopausal osteoporosis
Common side effects
- nausea with or without vomiting
- injection site inflammation
- flushing of the face or hands
Drug interactions
- lithium
Key clinical trials
- A Study to Compare Blood Levels of Different Dosage Formulations of the Study Medicine That Is a CGRP Receptor Antagonist in Healthy Adults (PHASE1)
- Paravertebral Calcitonin in Thoracotomy (NA)
- Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients (PHASE4)
- Evaluation of Pulpal and Salivary Neuropeptides in Dental Pain
- Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens (PHASE4)
- Prospective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET F-DOPA in Patients With a High Level of Postoperative Residual Thyrocalcitonin (NA)
- Procalcitonin and Threatened Premature Delivery (NA)
- Chinese Real-world Study of Treatment of Vestibular Migraine
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Osteobios CI brief — competitive landscape report
- Osteobios updates RSS · CI watch RSS
- Sanofi Aventis Us portfolio CI