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Cysteine Hydrochloride (CYSTEINE)

Exela Pharma · FDA-approved approved Small molecule Quality 50/100

Cysteine Hydrochloride (generic name: CYSTEINE) is a Vitamin C [EPC] Small molecule drug developed by Exela Pharma. It is currently FDA-approved (first approved 1986) for Amyloidosis, Atelectasis due to Mucous Obstruction, Bronchiectasis.

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 nameCYSTEINE
SponsorExela Pharma
Drug classVitamin C [EPC]
TargetCystine/glutamate transporter
ModalitySmall molecule
Therapeutic areaRespiratory
PhaseFDA-approved
First approval1986

Approved indications

Common side effects

Serious adverse events

Key clinical trials

Patents

PatentExpiryType

Primary sources

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SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial enrolment, design, endpoints, results
FDA Orange BookPatents + exclusivity

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Frequently asked questions about Cysteine Hydrochloride

What is Cysteine Hydrochloride?

Cysteine Hydrochloride (CYSTEINE) is a Vitamin C [EPC] drug developed by Exela Pharma, indicated for Amyloidosis, Atelectasis due to Mucous Obstruction, Bronchiectasis.

What is Cysteine Hydrochloride used for?

Cysteine Hydrochloride is indicated for Amyloidosis, Atelectasis due to Mucous Obstruction, Bronchiectasis, Bronchitis, Contrast Media-Induced Nephrotoxicity Prevention.

Who makes Cysteine Hydrochloride?

Cysteine Hydrochloride is developed and marketed by Exela Pharma (see full Exela Pharma pipeline at /company/exela-pharma).

What is the generic name of Cysteine Hydrochloride?

CYSTEINE is the generic (nonproprietary) name of Cysteine Hydrochloride.

What drug class is Cysteine Hydrochloride in?

Cysteine Hydrochloride belongs to the Vitamin C [EPC] class. See all Vitamin C [EPC] drugs at /class/vitamin-c-epc.

When was Cysteine Hydrochloride approved?

Cysteine Hydrochloride was first approved on 1986.

What development phase is Cysteine Hydrochloride in?

Cysteine Hydrochloride is FDA-approved (marketed).

What are the side effects of Cysteine Hydrochloride?

Common side effects of Cysteine Hydrochloride include Local infusion site reactions, Warm sensation at infusion site, Erythema at infusion site, Phlebitis at infusion site, Thrombosis at infusion site, Generalized flushing. Serious adverse events: Pulmonary embolism due to pulmonary vascular precipitates, Vein damage, Thrombosis, Increased BUN.

What does Cysteine Hydrochloride target?

Cysteine Hydrochloride targets Cystine/glutamate transporter and is a Vitamin C [EPC].

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