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Osmoprep (sodium phosphate, monobasic, monohydrate)
Osmoprep (generic name: sodium phosphate, monobasic, monohydrate) is a Calculi Dissolution Agent [EPC] drug developed by Salix Pharms. It is currently FDA-approved (first approved 2000) for Calcium renal calculus, Hypophosphatemia, Incomplete passage of stool.
Osmoprep is a medication used to treat various conditions, including arthropathy of the knee, pain, postoperative conditions, ureter stone, prostate cancer, and paroxysmal nocturnal hemoglobinuria. It is administered through interventions such as dexamethasone sodium phosphate, saline solution, and levobupivacaine, often in the context of a double-blinded randomized controlled study, as seen in the study "The Effect of Preoperative Steroids Injection on Pain and Oedema After Total Knee Arthroplasty."
At a glance
| Generic name | sodium phosphate, monobasic, monohydrate |
|---|---|
| Sponsor | Salix Pharms |
| Drug class | Calculi Dissolution Agent [EPC] |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2000 |
Approved indications
- Calcium renal calculus
- Hypophosphatemia
- Incomplete passage of stool
- Urinary tract infectious disease
Common side effects
Key clinical trials
- Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants (PHASE3)
- Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults (PHASE3)
- Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study (PHASE3)
- The Endovascular Plus GENe Therapy Versus Only EndoVascular Therapy for Severe Limb ischaemiA Trial (PHASE4)
- A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects (PHASE2)
- Long-Acting Treatment in Adolescents (LATA) (PHASE3)
- A Phase I/II Trial for Intravitreous Treatment of Severe Ocular Von Hippel-Lindau Disease Using a Combination of the PDGF Antagonist E10030 and the VEGF Antagonist Ranibizumab (PHASE1,PHASE2)
- Intra-articular PVA Hydrogel in Knee Osteoarthritis (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Osmoprep CI brief — competitive landscape report
- Osmoprep updates RSS · CI watch RSS
- Salix Pharms portfolio CI
Frequently asked questions about Osmoprep
What is Osmoprep?
What is Osmoprep used for?
Who makes Osmoprep?
What is the generic name of Osmoprep?
What drug class is Osmoprep in?
When was Osmoprep approved?
What development phase is Osmoprep in?
Related
- Drug class: All Calculi Dissolution Agent [EPC] drugs
- Manufacturer: Salix Pharms — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Calcium renal calculus
- Indication: Drugs for Hypophosphatemia
- Indication: Drugs for Incomplete passage of stool
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing