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Fulyzaq (Crofelemer) - Summary



FULYZAQ (crofelemer) delayed-release tablets is an anti-diarrheal, enteric-coated drug product for oral administration.

FULYZAQ is indicated for symptomatic relief of non-infectious diarrhea in patients with HIV/AIDS on anti-retroviral therapy.

See all Fulyzaq indications & dosage >>


Published Studies Related to Fulyzaq (Crofelemer)

Crofelemer: a review of its use in the management of non-infectious diarrhoea in adult patients with HIV/AIDS on antiretroviral therapy. [2013]
Crofelemer (Fulyzaq) is a botanical drug substance (oligomeric proanthocyanidin) extracted from the stem bark latex of the Croton lechleri tree. Crofelemer undergoes minimal systemic absorption following oral administration; it acts locally within the gastrointestinal (GI) tract by inhibiting the two principal chloride ion channels in the luminal membrane of enterocytes...

Evaluation of crofelemer in the treatment of diarrhea-predominant irritable bowel syndrome patients. [2008]
irritable bowel syndrome (D-IBS)... CONCLUSIONS: Crofelelmer did not produce benefit on bowel function; an increase

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Clinical Trials Related to Fulyzaq (Crofelemer)

Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea [Completed]
This is a randomized, double-blind, parallel-group, placebo-controlled, multi-center study. This study will compare an investigational new drug (crofelemer) to placebo for the control of HIV-associated diarrhea. The first stage of the study will determine the optimal dose of study drug based on safety and response to therapy and the second stage will evaluate further the effectiveness of the optimal dose.

Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea [Completed]
This study is being conducted to evaluate the safety and tolerability of crofelemer 125 mg twice a day, taken orally, over 48 weeks of therapy in human immunodeficiency virus-positive (HIV+) subjects with diarrhea.

A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome [Completed]
This study is designed to evaluate the safety and effectiveness of an investigational drug, TRN-002 (crofelemer) to relieve the symptoms of diarrhea-predominant irritable bowel syndrome (IBS).

Diarrhea Predominant Irritable Bowel Syndrome in Females [Completed]
Clinical Trial with TRN-002 in Women with Irritable Bowel Syndrome (IBS) The purpose of this study is to investigate the safety and effectiveness of a new investigational drug in women for the treatment of diarrhea-predominant irritable bowel syndrome. The investigational drug is a natural product taken from a plant that grows in South America. The study medication will be administered orally twice a day. Subjects will be not able to remain on certain standard IBS medications (anti-diarrheals) while participating in the study. The total duration of the study is 18 weeks. The study requires five study visits that include physical exams, ECG, blood draws, laboratory studies, and a colon procedure (such as a colonoscopy or flexible sigmoidoscopy if an appropriate procedure has not been performed in the last 5 years.) Participants will be asked to make entries into a touch-tone telephone diary on a daily basis. Participants must meet all of the following criteria:

- Females at least 18 years of age

- Diagnosis of diarrhea predominant Irritable Bowel Syndrome

- Willingness to make daily calls on a touch-tone telephone

- Willingness to have an endoscopic and/or radiologic bowel evaluation, if you have not

received one in the past 5 years.

- Willingness to take an approved method of birth control (if required)

Participants CANNOT meet any of the following criteria:

- Serious medical or surgical conditions

- Colon Cancer, Crohns Disease or Ulcerative Colitis

- Pregnant or breast feeding

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) Patients [Completed]
To evaluate the efficacy, safety, and durability of response of SP-303 in decreasing stool weight in AIDS patients with diarrhea over 6 days of treatment.

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Page last updated: 2015-08-10

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