Last reviewed · How we verify
Cystadane (BETAINE)
At a glance
| Generic name | BETAINE |
|---|---|
| Sponsor | Recordati |
| Drug class | Methylating Agent [EPC] |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1996 |
Approved indications
- Bacterial urinary infection
- Complicated Proteus UTI
- Complicated UTI with Pseudomonas Aeruginosa
- Cystitis
- E. Coli Pyelonephritis
- Enterococcus Complicated UTI
- Escherichia coli urinary tract infection
- Homocystinuria
- Infective cystitis
- Klebsiella cystitis
- Urinary tract infection caused by Klebsiella
Common side effects
- Mild transient diarrhea
- Itching
- Transitory exanthema
- Feeling of swelling of entire body
Serious adverse events
- Polycythemia vera
- Allergic sensitization
Key clinical trials
- Maternal Betaine Supplementation During Breastfeeding (PHASE1,PHASE2)
- Modulating Early-life Nutrition for Childhood Obesity Prevention (NA)
- Pharmacokinetic Assessment of Betaine Supplementation in Lactating Mothers (NA)
- Nicotinamide Mononucleotide Supplementation for Exercise Tolerance Improvement in Healthy Older Adults (NA)
- Efficacy of Essential Phospholipid Versus Betaine HCL/L-Glutamic Acid in MAFLD
- Betaine vs. Placebo for Serologically Diagnosed Metabolic Dysfunction-associated Steatohepatitis (MASH) (PHASE2)
- Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs. (NA)
- Betaine Supplementation and Lipid Metabolism in Overweight and Obese Pre-menopausal Women (NA)
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:
- Cystadane CI brief — competitive landscape report
- Cystadane updates RSS · CI watch RSS
- Recordati portfolio CI