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Saline alone
Saline alone is a Small molecule drug developed by Washington University School of Medicine. It is currently FDA-approved for Control/comparator arm in clinical trials (not a therapeutic indication).
Saline alone is a physiological salt solution that serves as a control or placebo comparator in clinical studies rather than an active therapeutic agent.
Saline is a solution that can be used as a placebo in medical studies. It is also known as Potassic Saline or Lactated Saline, and its modality is unknown.
At a glance
| Generic name | Saline alone |
|---|---|
| Sponsor | Washington University School of Medicine |
| Modality | Small molecule |
| Phase | FDA-approved |
Mechanism of action
Normal saline (0.9% sodium chloride in water) is an isotonic solution that maintains osmotic balance and is used primarily as a vehicle for drug delivery or as a control arm in clinical trials. It has no inherent pharmacological mechanism of action beyond providing hydration and electrolyte balance. In research contexts, saline alone is used to establish baseline efficacy and safety profiles of investigational drugs.
Approved indications
- Control/comparator arm in clinical trials (not a therapeutic indication)
Common side effects
- Hyperchloremic acidosis (with large volumes)
- Fluid overload
- Hypernatremia (with prolonged use)
Key clinical trials
- PRP Injection Into the Sacroiliac Joint After Ipsilateral THA: Effects on Early Recovery and Function (SIJ-THA Randomized Trial) (NA)
- Endorotor Resection In Refractory Barrett's Dysplasia Patients (NA)
- Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection (PHASE2)
- Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function (NA)
- Safety and Immunogenicity of an Inactivated West Nile Virus Vaccine in Healthy Adults (PHASE1)
- MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM) (PHASE3)
- Sphenopalatine Ganglion Block for Post-Dural Puncture Headache: A Pilot Randomised Controlled Trial (NA)
- Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1 (PHASE1, PHASE2)
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 |
|---|---|
| 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:
- Saline alone CI brief — competitive landscape report
- Saline alone updates RSS · CI watch RSS
- Washington University School of Medicine portfolio CI
Frequently asked questions about Saline alone
What is Saline alone?
How does Saline alone work?
What is Saline alone used for?
Who makes Saline alone?
What development phase is Saline alone in?
What are the side effects of Saline alone?
Related
- Manufacturer: Washington University School of Medicine — full pipeline
- Indication: Drugs for Control/comparator arm in clinical trials (not a therapeutic indication)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing