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Cysteine Hydrochloride (CYSTEINE)
Cysteine Hydrochloride (CYSTEINE) is a small molecule drug originally developed by HOSPIRA and currently owned by Exela Pharma. It targets the cystine/glutamate transporter and is FDA-approved for various indications, including amyloidosis, cystic fibrosis, and contrast media-induced nephrotoxicity prevention. CYSTEINE is a cysteine drug that works by replenishing cysteine levels in the body, which is essential for various cellular functions. It is a patented drug with no generic manufacturers. Key safety considerations include its potential effects on the kidneys and liver.
At a glance
| Generic name | CYSTEINE |
|---|---|
| Sponsor | Exela Pharma |
| Drug class | Vitamin C [EPC] |
| Target | Cystine/glutamate transporter |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
| First approval | 1986 |
Approved indications
- Amyloidosis
- Atelectasis due to Mucous Obstruction
- Bronchiectasis
- Bronchitis
- Contrast Media-Induced Nephrotoxicity Prevention
- Cystic fibrosis of the lung
- General anesthesia
- Poisoning by acetaminophen
- Thick Bronchial Secretions
Common side effects
- Local infusion site reactions
- Warm sensation at infusion site
- Erythema at infusion site
- Phlebitis at infusion site
- Thrombosis at infusion site
- Generalized flushing
- Fever
- Nausea
Serious adverse events
- Pulmonary embolism due to pulmonary vascular precipitates
- Vein damage
- Thrombosis
- Increased BUN
- Acid-base imbalance
- Hepatobiliary disorders
- Hyperammonemia
- Aluminum toxicity
Key clinical trials
- Effects of NAC on Symptoms of CHR Patients (NA)
- Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections: N-Acetylcysteine (PHASE4)
- Glutathione in Mild Cognitive Impairment (EARLY_PHASE1)
- A Study to Explore if Long-term Use of Mucinex Can Help With Symptoms in Patients With Stable Chronic Bronchitis. (PHASE4)
- Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial (PHASE3)
- N-Acetylcysteine for Smoking Cessation in Tobacco and Cannabis Co-Use (PHASE4)
- A Clinical Trial Via Telepsychiatry of Treatments for the Management of Emotional Dysregulation in Youth (PHASE4)
- Comparative Clinical Study to Evaluate the Possible Efficacy and Safety of Oral N-Acetyl Cysteine Versus Rectal Diclofenac in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis (PHASE1,PHASE2)
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:
- Cysteine Hydrochloride CI brief — competitive landscape report
- Cysteine Hydrochloride updates RSS · CI watch RSS
- Exela Pharma portfolio CI