Duzallo

Hyperuricemia, Lesch-Nyhan Syndrome, Chemotherapy + 15 more

Treatment

16 FDA approvals

20 Active Studies for Duzallo

What is Duzallo

Allopurinol

The Generic name of this drug

Treatment Summary

Gout is an inflammatory condition caused by the accumulation of monosodium urate crystals in the body, especially around joints. It has been known since ancient times and has been documented in medical records and biographies. Allopurinol is a common medication used to reduce urate levels and treat chronic gout. It was approved by the FDA in 1966 and is now made by several different companies.

Zyloprim

is the brand name

image of different drug pills on a surface

Duzallo Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Zyloprim

Allopurinol

1966

270

Approved as Treatment by the FDA

Allopurinol, also called Zyloprim, is approved by the FDA for 16 uses such as female patients with daily uric acid excretion that exceeds 750 mg/day and Cancer .

female patients with daily uric acid excretion that exceeds 750 mg/day

Cancer

Kidney Calculi

Hyperuricemia

Leukemias

Malignant Lymphomas

Arthritis, Gouty

Used to treat Gouty Arthritis in combination with Lesinurad

failed previous allopurinol monotherapy

Used to treat failed previous allopurinol monotherapy in combination with Lesinurad

Hyperuricemia

Hyperuricemia

Chemotherapy

Lymphoma, Non-Hodgkin

Leukemia

Symptomatic

Secondary gout

Primary Gout

Effectiveness

How Duzallo Affects Patients

Allopurinol works by reducing the amount of uric acid the body makes. This helps to relieve the symptoms of gout such as painful swelling, joint pain, redness, and difficulty moving.

How Duzallo works in the body

Allopurinol helps reduce gout symptoms by blocking an enzyme that converts hypoxanthine to xanthine and xanthine to uric acid. This drug also increases the amount of hypoxanthine and xanthine for nucleotide and nucleic acid synthesis. As a result, uric acid levels in the urine and blood drop, which reduces the risk of gout symptoms. Allopurinol also encourages the dissolution of existing gout tophi by lowering the amount of uric acid in the blood below its solubility limit. Although hypoxanthine and xanthine levels increase after allop

When to interrupt dosage

The recommended dosage of Duzallo is contingent upon the diagnosed condition, including Gout Flares, Leukemias and Cancer. The amount of dosage is contingent on the method of delivery (e.g. Injection, powder, lyophilized, for solution - Intravenous or Tablet, film coated - Oral) provided in the following table.

Condition

Dosage

Administration

Symptomatic

, 300.0 mg, 100.0 mg, 50.0 mg/mL, 200.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Capsule - Oral, Capsule, Tablet, film coated, Tablet, film coated - Oral

Chemotherapy

, 300.0 mg, 100.0 mg, 50.0 mg/mL, 200.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Capsule - Oral, Capsule, Tablet, film coated, Tablet, film coated - Oral

Chronic Kidney Disease (CKD)

, 300.0 mg, 100.0 mg, 50.0 mg/mL, 200.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Capsule - Oral, Capsule, Tablet, film coated, Tablet, film coated - Oral

Metabolic Diseases

, 300.0 mg, 100.0 mg, 50.0 mg/mL, 200.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Capsule - Oral, Capsule, Tablet, film coated, Tablet, film coated - Oral

Gout Flares

, 300.0 mg, 100.0 mg, 50.0 mg/mL, 200.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Capsule - Oral, Capsule, Tablet, film coated, Tablet, film coated - Oral

Eczema

, 300.0 mg, 100.0 mg, 50.0 mg/mL, 200.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Capsule - Oral, Capsule, Tablet, film coated, Tablet, film coated - Oral

Leukemia

, 300.0 mg, 100.0 mg, 50.0 mg/mL, 200.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Capsule - Oral, Capsule, Tablet, film coated, Tablet, film coated - Oral

Primary Gout

, 300.0 mg, 100.0 mg, 50.0 mg/mL, 200.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Capsule - Oral, Capsule, Tablet, film coated, Tablet, film coated - Oral

Hyperuricemia

, 300.0 mg, 100.0 mg, 50.0 mg/mL, 200.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Capsule - Oral, Capsule, Tablet, film coated, Tablet, film coated - Oral

Lesch-Nyhan Syndrome

, 300.0 mg, 100.0 mg, 50.0 mg/mL, 200.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Capsule - Oral, Capsule, Tablet, film coated, Tablet, film coated - Oral

Arthritis, Gouty

, 300.0 mg, 100.0 mg, 50.0 mg/mL, 200.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Capsule - Oral, Capsule, Tablet, film coated, Tablet, film coated - Oral

Kidney Calculi

, 300.0 mg, 100.0 mg, 50.0 mg/mL, 200.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Capsule - Oral, Capsule, Tablet, film coated, Tablet, film coated - Oral

female patients with daily uric acid excretion that exceeds 750 mg/day

, 300.0 mg, 100.0 mg, 50.0 mg/mL, 200.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Capsule - Oral, Capsule, Tablet, film coated, Tablet, film coated - Oral

failed previous allopurinol monotherapy

, 300.0 mg, 100.0 mg, 50.0 mg/mL, 200.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Capsule - Oral, Capsule, Tablet, film coated, Tablet, film coated - Oral

Hyperuricemia

, 300.0 mg, 100.0 mg, 50.0 mg/mL, 200.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Capsule - Oral, Capsule, Tablet, film coated, Tablet, film coated - Oral

Urinary Bladder Calculi (disorder)

, 300.0 mg, 100.0 mg, 50.0 mg/mL, 200.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Capsule - Oral, Capsule, Tablet, film coated, Tablet, film coated - Oral

Lymphoma, Non-Hodgkin

, 300.0 mg, 100.0 mg, 50.0 mg/mL, 200.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Capsule - Oral, Capsule, Tablet, film coated, Tablet, film coated - Oral

Secondary gout

, 300.0 mg, 100.0 mg, 50.0 mg/mL, 200.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Capsule - Oral, Capsule, Tablet, film coated, Tablet, film coated - Oral

Warnings

There are 20 known major drug interactions with Duzallo.

Common Duzallo Drug Interactions

Drug Name

Risk Level

Description

Didanosine

Major

The serum concentration of Didanosine can be increased when it is combined with Allopurinol.

Oteracil

Major

The therapeutic efficacy of Oteracil can be decreased when used in combination with Allopurinol.

Pegloticase

Major

The risk or severity of adverse effects can be increased when Allopurinol is combined with Pegloticase.

Abacavir

Minor

Allopurinol may decrease the excretion rate of Abacavir which could result in a higher serum level.

Aclidinium

Minor

Allopurinol may decrease the excretion rate of Aclidinium which could result in a higher serum level.

Duzallo Toxicity & Overdose Risk

The lowest toxic dose for rats is 10 mg/kg, while the lowest toxic dose for mice is 78 mg/kg. Reproductive studies on rats and rabbits have not shown any adverse effects, but there have been reports of increased numbers of dead fetuses and malformations in pregnant mice given 50 or 100 mg/kg allopurinol. Nursing women should be cautious while taking allopurinol as it has been found in the milk of a nursing mother. Studies have not found allopurinol to be mutagenic or carcinogenic.

image of a doctor in a lab doing drug, clinical research

Duzallo Novel Uses: Which Conditions Have a Clinical Trial Featuring Duzallo?

560 active clinical trials are investigating the potential of Duzallo to mitigate Kidney Disease, Chemotherapy-related complications and Metabolic Diseases.

Condition

Clinical Trials

Trial Phases

Chronic Kidney Disease (CKD)

28 Actively Recruiting

Phase 3, Not Applicable, Phase 2, Phase 1, Phase 4

failed previous allopurinol monotherapy

0 Actively Recruiting

Secondary gout

0 Actively Recruiting

Lymphoma, Non-Hodgkin

1 Actively Recruiting

Phase 1

Leukemia

1 Actively Recruiting

Not Applicable

Eczema

9 Actively Recruiting

Phase 2, Early Phase 1, Not Applicable, Phase 3

Lesch-Nyhan Syndrome

0 Actively Recruiting

Arthritis, Gouty

0 Actively Recruiting

Hyperuricemia

0 Actively Recruiting

Chemotherapy

4 Actively Recruiting

Phase 1, Phase 3, Not Applicable

female patients with daily uric acid excretion that exceeds 750 mg/day

0 Actively Recruiting

Kidney Calculi

0 Actively Recruiting

Metabolic Diseases

1 Actively Recruiting

Not Applicable

Hyperuricemia

3 Actively Recruiting

Phase 3, Phase 1

Urinary Bladder Calculi (disorder)

0 Actively Recruiting

Primary Gout

0 Actively Recruiting

Gout Flares

1 Actively Recruiting

Phase 2

Symptomatic

0 Actively Recruiting

Duzallo Reviews: What are patients saying about Duzallo?

3.7

Patient Review

10/21/2018

Duzallo for Treatment to Prevent Gout

I experienced a lot of side effects with this medication.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about duzallo

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does allopurinol do?

"This medication is used to lower the level of uric acid in your blood. Uric acid build-up can cause tiny, sharp crystals to form in and around your joints, which is a condition known as gout. Kidney stones can also be caused by too much uric acid. Allopurinol is used to prevent these conditions from occurring or to lessen their symptoms."

Answered by AI

Why was lesinurad discontinued?

"- The FDA has announced the discontinuation of Ironwood Pharmaceuticals' Duzallo (lesinurad/allopurinol) and Zurampic (lesinurad). This is due to business reasons and not because of any safety, efficacy or quality issues."

Answered by AI

What is Duzallo used for?

"Duzallo is a medication used to lower uric acid levels in adults with gout. It is typically given when allopurinol alone has not been effective."

Answered by AI

Clinical Trials for Duzallo

Image of UPMC Hillman Cancer Center in Pittsburgh, United States.

Mobile App for Cancer

18+
All Sexes
Pittsburgh, PA

The goal of this study is to determine whether a mobile application that combines real-time sensor data and patient-reported symptoms to trigger care-team contact recommendations is feasible and beneficial for patients receiving chemotherapy. The main questions it aims to answer are: * Is the mobile application feasible and acceptable to patients? * Do the alerts and guidance improve symptom management, quality of life, and engagement with the care team during treatment? Participants will: * Complete a demographic questionnaire at the beginning of the study and quality-of-life and health questionnaires at the beginning, midpoint, and end of study. * Complete daily symptom ratings via study application. * Wear a Fitbit activity tracker for 90 days. * At the end of the study, complete a semi-structured interview to provide feedback on the study. * Optional: At the beginning and end of the study, complete an in-person physical function assessment measuring balance (Short Physical Performance Battery).

Waitlist Available
Has No Placebo

UPMC Hillman Cancer Center

Carissa A Low

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Image of South Florida Research Institute in Lauderdale Lakes, United States.

Mezagitamab for Berger's Disease

18+
All Sexes
Lauderdale Lakes, FL

Immunoglobulin A nephropathy (IgAN) is a kidney condition. It happens when the body's immune system creates groups of proteins (called immune complexes) that build-up in the kidneys causing swelling (inflammation). Over time, this inflammation may lead to kidney damage and cause the kidneys to no longer work properly. The main aim of this study is to check how well mezagitamab changes protein levels in the urine (proteinuria) compared to placebo in adults with primary IgAN. A placebo looks like medicine but doesn't have any active ingredients in it. Other aims are to check how safe mezagitamab is and how well participants with primary IgAN can tolerate it compared to placebo, and to find out if and how well mezagitamab continues to maintain kidney function over the long term compared to placebo. Participants will be placed in 1 of the 2 treatment groups; the main group and the open-label group. In the main group, participants will be placed in 1 of the 2 treatment groups by chance (either mezagitamab or placebo) at a 2:1 ratio. This means that out of 3 participants, 2 will receive mezagitamab and 1 will receive placebo. The participants will receive either mezagitamab or placebo for almost half a year in two 1-year cycles. They will be observed for another half year in each 1-year cycle and will have check-ups about every month during this time. In the open-label group, a small number of participants who have lower levels of protein in their urine or have kidneys that do not filter the blood well, will receive mezagitamab treatment. This will include participants who have previously received mezagitamab in another study, TAK-079-1006. Every participant will receive mezagitamab in the same way as those in the main group receiving mezagitamab. During the study, participants will visit their study clinic several times.

Phase 3
Recruiting

South Florida Research Institute (+20 Sites)

Study Director

Takeda

Image of PAREXEL International - Early Phase Clinical Unit Baltimore in Baltimore, United States.

NNC4004-0002 for High Uric Acid

35 - 75
All Sexes
Baltimore, MD

This study will evaluate an investigational drug called NNC4004-0002. "Investigational" means NNC4004-0002 has not been approved for sale/ for clinical use or for the use described in this study/ by any regulatory authority. Its use in this study is experimental. This will be the first time that NNC4004-0002 will be given to human. This study will be testing the ability of the study medicine to lower serum uric acid. The main aim of this study will be to see if the new study medicine is safe and tolerated by the body after a single dose of study medicine in adults with asymptomatic hyperuricemia. Participants will either get NNC4004-0002 (the study medicine), or saline. Which treatment the participant get will be decided by chance. The participant will get the medicine as an injection under their skin. Depending on the dose they will receive, participant may need more than one injection. The study will last for about 19 months in total. The participant will take part in the study for about 7 months. Participant will have approximately 14 visits to the clinic and one of them will be a 4 night in-house stay.

Phase 1
Recruiting

PAREXEL International - Early Phase Clinical Unit Baltimore (+2 Sites)

Clinical Transparency (dept. 2834)

Novo Nordisk A/S

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