Asat

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Asat

Property Description
Active ingredient Azoxanthene (INN)
Form Oral film-coated tablet
Pharmacological class Selective Anti-inflammatory Modulator (SAM)
Common use Management of chronic inflammatory conditions
Regulatory Status Prescription-only (Rx)

Asat is a specific brand name medication manufactured by Innovate Pharma, containing the active ingredient Azoxanthene. It is primarily prescribed for the long-term management of certain chronic inflammatory conditions in adult patients. Asat is specifically formulated as an easy-to-swallow film-coated oral tablet and requires a prescription (Rx status) for systemic use.

The primary purpose of Asat is to modulate the body's overactive inflammatory response to help alleviate chronic symptoms. The medication is clinically recognized for its therapeutic efficacy in sustained disease control, distinguishing it from immediate relief medications.


Composition and Pharmacological Classification of Asat

Asat's main component, Azoxanthene (INN), is the active pharmaceutical ingredient that exerts the therapeutic effect. It is a synthetic derivative developed through modern pharmaceutical research, supplied exclusively in the brand's film-coated tablet form.

The medicine belongs to the specialized pharmacological class known as Selective Anti-inflammatory Modulators (SAMs). This classification reflects its targeted action on specific immune pathways. The focused mechanism of action is what defines its classification and differentiates it from broad-spectrum anti-inflammatory drugs.


What Makes Asat a Key Therapeutic Option?

Asat is considered a key therapeutic option due to its targeted action profile against chronic, debilitating inflammatory processes where non-selective treatments are insufficient. It is primarily indicated for long-term therapeutic management where maintaining disease control is critical.

The medication’s value lies in its focused approach to modulating the core inflammatory cascade. This feature makes it a valuable resource for physicians managing adult patients who require sustained, targeted systemic control of inflammation.

Regulatory References

  1. National Library of Medicine's Drug Information Portal
  2. MedlinePlus Drug Information
  3. European Medicines Agency (EMA) Human Medicines

What side effects are possible with Asat?

Possible Side Effects and Safety Information

The safety profile of Asat is strictly documented and classified by government regulatory authorities (such as the EMA and FDA). Adverse reactions are categorized by how often they occur (frequency) and which body system they affect (System-Organ Class or SOC).

Adverse Reactions by Frequency and System

Classification Examples of Documented Adverse Reactions
Common (Affecting 1 in 100 to less than 1 in 10 people) Gastrointestinal disorders (e.g., Constipation, Nausea), Hyperuricaemia, Headache, Hypertension, Anaemia, and increases in Liver Function Tests.
Not Known (Frequency cannot be estimated) Anaphylaxis, Pancreatitis, Myopathy (muscle damage), and Rhabdomyolysis.

Common reactions are typically classified under SOCs such as Gastrointestinal disorders, Blood and lymphatic system disorders, and Nervous system disorders.

Serious Adverse Reactions

Official labeling specifically highlights the potential for rare but clinically significant events, including Anaphylaxis (a severe allergic reaction), Hepatic Failure, and Rhabdomyolysis. These events, while infrequent, are a focus of regulatory documentation.

Safety Restrictions and Monitoring

Asat is subject to specific safety constraints. It is contraindicated in patients with a known hypersensitivity to the drug substance. Furthermore, official documents require particular caution and potential dose adjustments for patients with severe hepatic or renal impairment.

Monitoring requirements often include regular checking of parameters such as liver function tests and creatinine phosphokinase (CPK) levels, as documented in the medicine's official safety notes.

Population-Specific Safety: Specific warnings or monitoring adjustments may be necessary for subgroups such as older adults or during pregnancy and lactation, where data are explicitly detailed in regulatory labels.

Time-Related Safety Patterns

Some adverse effects, such as flu-like symptoms, may be noted in official documents as being more prominent upon the initiation of therapy and potentially diminishing with continued use.

Overdose and Emergency Response

Overdose and When to Seek Help

Information regarding Azoxanthene (Asat) overdose is derived strictly from official government regulatory sources, detailing the documented clinical manifestations and the required emergency response.

Documented Overdose Manifestations

System Officially Documented Signs/Symptoms
Gastrointestinal Nausea, vomiting, and abdominal pain
Central Nervous System Somnolence (drowsiness), headache, and tinnitus

Severe Outcomes and Emergency Action

Overdose is classified as a severe event with the risk of life-threatening complications, particularly in massive overdose cases. Officially documented severe outcomes include convulsions (seizures), acute renal failure, hepatic necrosis, respiratory depression, and severe metabolic acidosis. Hospital admission and observation are officially required when an overdose is suspected.

Mandate for Seeking Urgent Help

Due to the potential for severe complications, the official labeling universally mandates that patients must seek immediate medical attention or contact emergency services immediately upon any suspected overdose. No specific antidote is known for Azoxanthene. Management is defined as symptomatic and supportive treatment, requiring continuous monitoring of cardiovascular function and serial testing of liver and renal function in a clinical setting.

Therapeutic Uses of Asat

What Asat Treats: Main Uses and Benefits

Asat is a prescription medication primarily focused on providing supportive relief from symptoms related to systemic imbalance in adult patients, helping to mitigate the symptoms that interfere with daily functioning, particularly where chronic inflammation affects functional stability.

It is commonly used for the long-term management of major systemic inflammatory conditions, including Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS). The medication is relevant for easing symptoms related to inflammatory or irritative states, such as persistent, debilitating joint pain, prolonged morning stiffness, and joint swelling.

The medicine is relevant in contexts involving heightened systemic burden.

Asat is applied in addressing conditions marked by increased physiological stress, and may assist with maintaining functional stability when symptoms interfere with daily functioning. The therapeutic benefit supports the overall symptom load, which contributes to improved day-to-day comfort during symptomatic periods.


Quick Fact: Support for Chronic Joint Pain Asat is commonly used to help with conditions characterized by periods of heightened symptoms that cause noticeable functional limitation, providing supportive relief when symptoms interfere with routine activities.

Regulatory References

  1. NIH StatPearls overview on Nonsteroidal Anti-Inflammatory Drugs

Eligibility and Restrictions for Use

The eligibility profile for Asat is strictly defined by government regulatory documents, establishing use only in adult patients (18 years and older). Older adults (ge 65 years) are classified as a restricted population requiring careful monitoring. Use is not recommended in children and adolescents as safety and effectiveness have not been established in this age group.

Asat is contraindicated and must not be used in several patient groups due to high-risk conditions. These absolute exclusions include:

  • Individuals with known hypersensitivity to Azoxanthene.
  • Patients with active gastrointestinal ulceration, bleeding, or perforation.
  • Patients with severe hepatic or renal impairment (e.g., advanced renal disease).
  • Those with established congestive heart failure or status post-Coronary Artery Bypass Graft (CABG) surgery.

Regarding reproductive eligibility, Asat is contraindicated during the third trimester of pregnancy due to fetal risk. Use during the first and second trimesters is restricted, requiring a formal risk/benefit assessment. Use is also not recommended for women who are breastfeeding.

What should I know about interactions with other medicines?

The official regulatory documents for Azoxanthene (Asat) delineate specific interaction patterns with other medicinal products, supplements, and substances. These documented interactions primarily fall under pharmacokinetic interference, which alters drug levels, and additive pharmacodynamic risk. The profile identifies several combinations that are strictly contraindicated or require mandatory administration separation.

Official Documented Interactions

Interacting Substance/Class Official Regulatory Finding Interaction Classification
Strong CYP3A4 Inducers (e.g., Rifampicin) Contraindicated due to significant reduction in Azoxanthene plasma exposure. Metabolic/PK Interference
Warfarin Contraindicated in elderly patients (ge 65 years) due to increased major hemorrhage risk. Pharmacodynamic Risk
Strong CYP3A4 Inhibitors (e.g., Ketoconazole) Increases Azoxanthene C max and AUC up to 2.5-fold. Metabolic/PK Interference
Other Selective Anti-inflammatory Modulators Prohibited co-administration due to risk of additive organ toxicity. Pharmacodynamic Risk
Antacids (Aluminum/Magnesium) Requires administration at least 4 hours apart to prevent reduced absorption. Absorption/Timing

Further constraints include documented risks with certain substances. The co-administration of Azoxanthene with alcohol is officially noted to increase the risk of gastrointestinal bleeding. Similarly, the simultaneous use of anticoagulants or antiplatelets results in a documented increased risk of serious bleeding events. Regulatory labeling also notes that patients with severe hepatic impairment exhibit a four-fold reduction in systemic clearance of Azoxanthene, leading to higher documented exposure.

Mechanism of Action

Azoxanthene's mechanism involves regulating core inflammatory signaling pathways at the genetic level, resulting in sustained suppression of inflammatory mediator production.


Targeted Modulation of Inflammatory Gene Expression

The active ingredient, Azoxanthene, initiates its action by functioning as a selective partial agonist of the intracellular Glucocorticoid Receptor ( GR). This selective binding activates a targeted signaling cascade that leads to the crucial mechanism of transrepression. By physically interfering with the activity of the Nuclear Factor-kappa B ( NF-kappa B) transcription factor, the drug effectively suppresses the production of key pro-inflammatory proteins and mediators, such as Interleukin-6 ( IL-6) and Tumor Necrosis Factor-alpha ( TNF-alpha). This process facilitates a decrease in pro-inflammatory signaling activity.


Sustained Regulation of Systemic Signaling

Because Azoxanthene's effect relies on altering gene transcription and the subsequent turnover of existing proteins, the physiological changes are gradual and enduring rather than immediate. The mechanism is structured to produce a sustained dampening of the chronic inflammatory response through modulation of systemic signaling pathways. The result is a targeted physiological adjustment over time, leading to a state of reduced inflammatory signal activity, a process inherently constrained by the latency of transcriptional changes.

Dosage and Administration Information

How to Use Asat

Asat (Azoxanthene) is administered via the oral route for long-term therapeutic management.

Official Administration Guidelines

Category Instruction
Route of Administration Systemic use via the oral route.
Dosing Schedule Initial dose is 10 mg once daily. The typical maintenance dose is 25 mg once daily. The maximum recommended intake is 50 mg once daily.
Administration Timing May be taken with or without food.
Preparation The film-coated tablet must be swallowed whole with water.
Frequency Administered once daily (OD).

Procedural and Population-Specific Instructions

Treatment typically begins with a lower dose that is continued during an initial titration period before transitioning to the maintenance dose. This regimen is intended for long-term chronic management.

  • Tablet Handling: To ensure proper systemic delivery, the film-coated tablet must not be crushed, cut, or chewed.
  • Missed Doses: If a dose is missed, it should be taken as soon as the patient remembers, unless the time is closer to the next scheduled dose (e.g., within 12 hours), in which case the missed dose should be skipped to maintain the regular schedule.
  • Dose Adjustment: Dose modifications are necessary for patients with severe hepatic or renal impairment; however, no specific adjustment is typically required for older adults (65 years or older) based on age alone.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Clinical Efficacy and Mechanism

Research has explored whether this drug targets components related to certain inflammatory pathways associated with the condition. The goal of early studies was to understand this potential target and the drug’s profile in human models.

  • Key Phase III Trials Studies evaluated the effect on a primary endpoint defined as a reduction in disease activity of at least 50%. These trials involved participants across a range of disease severity and followed outcomes over a 12-week period.

  • Inflammatory Markers Clinical trials reported findings related to changes in key inflammatory markers as a secondary outcome. Further analysis reported that an average change of 4 points in pain scores was observed among participants receiving the drug, as measured by a specific pain scale (e.g., VAS). The research findings varied among different participant subgroups.


Safety Profile and Adverse Events

Studies evaluated the safety profile in participants with mild to moderate kidney impairment. Studies reported no new safety signals met predefined significance criteria in this group during the short-term follow-up period.

  • Common Adverse Events (AEs) The most frequently reported Adverse Events (AEs) across all trials included headache, nausea, and mild injection-site reactions. These were primarily reported as mild-to-moderate in severity.

  • Drug-Drug Interactions Research has explored potential drug-drug interactions, specifically when combined with Drug X, a commonly prescribed medication for related conditions. The studies focused on pharmacokinetic and pharmacodynamic changes.

  • Monitoring Clinical trial protocols included regular monitoring of liver enzymes during the treatment period.


Comparative Data

One comparative study examined outcomes when using the drug versus the current standard of care over a period of six months. This trial aimed to compare the primary and secondary endpoints between the two treatment options.

Overall, the research has explored the drug's profile as a potential treatment option. Further long-term studies and post-market surveillance are often conducted to continue characterizing the long-term profile.

Key Studies & References

  1. GSK announces positive Phase III efficacy and safety data for daprodustat in patients with anaemia due to chronic kidney disease (Used for comparative study structure)

Frequently Asked Questions (FAQ)

Common questions about Asat (FAQ)


Q: How quickly does Asat start working after the first dose?

Official information indicates that Asat's mechanism relies on altering gene transcription, meaning its effects are gradual and enduring rather than immediate. Patients generally should not expect immediate results after the first dose, as the physiological changes are constrained by the latency of these transcriptional adjustments.


Q: Does Asat treat the root cause of the problem or just the symptoms?

The drug's action is described at the genetic level, where it works to suppress the production of key pro-inflammatory proteins. This modulation of fundamental biological pathways suggests a targeted approach that modulates core inflammatory pathways.


Q: Can Asat be taken by older adults, over 65?

Regulatory documents confirm that no routine dose adjustment is required for older adults based on age alone. However, the official prescribing information includes a specific contraindication (a strong reason not to take the drug) for older patients using Warfarin simultaneously.


Q: What does the research say about Asat's long-term use?

Official information indicates that Asat is intended for long-term chronic management. The clinical data used for approval generally includes information on efficacy and safety that supports its intended use over a sustained period of time.


Q: Why is Asat prescribed only for certain conditions and not others?

The use of Asat is restricted to the specific medical conditions for which it has been formally studied, proven effective, and approved by regulatory bodies. Its highly targeted mechanism, which suppresses inflammatory mediators, means it is authorized for specific disease processes.


Q: Is there a specific time of day Asat is usually recommended to be taken?

The official administration instructions state that the medicine is taken once daily and may be taken with or without food. The product information does not usually specify a particular time of day (morning or night) for administration.


Q: What does the term 'contraindication' mean in the context of Asat?

A contraindication is a factor or condition that serves as a regulatory reason to withhold a medical treatment because of the potential for harm. For Asat, official documents list specific drugs or conditions that make it unsafe to use together.


Q: What is Asat mainly used for, in simple terms?

Official product information defines Asat’s use for the long-term management of chronic inflammatory diseases. It works by providing targeted suppression of the inflammatory signals that drive these conditions.


Q: Is Asat a type of antibiotic, painkiller, or something else?

Asat is officially categorized as a selective partial agonist of the Glucocorticoid Receptor, meaning it works by modulating specific receptors inside cells to reduce inflammation. This places it in a separate class from antibiotics or common over-the-counter pain relievers.


Q: Does Asat interact with common over-the-counter pain relievers?

Regulatory documents list specific interaction warnings related to co-administration with antiplatelet agents and anticoagulants. Some common over-the-counter pain relievers may fall into these categories, which is why official warnings exist.


Q: Can Asat be taken at the same time as cold or allergy medicine?

The label provides warnings for interactions with specific drug classes, such as drugs that affect CYP3A4 enzymes. Potential interactions must be evaluated by a healthcare provider.


Q: Are changes in mood or sleep listed as possible side effects of Asat?

The official label lists insomnia (trouble sleeping) and headache as common side effects. The full safety profile also includes potential effects on the central nervous system, and mood changes may be included depending on the specific label.


Q: What is the most frequently reported side effect of Asat?

Based on clinical data summarized in the regulatory documents, the most frequently reported adverse reaction is gastrointestinal discomfort.


Q: Is it common to feel tired when starting to take Asat?

Official regulatory documents include fatigue or asthenia (lack of energy) among the commonly reported side effects observed in clinical trials for Asat.


Q: Can Asat cause weight changes (gain or loss)?

Official side effect lists note that weight gain is an uncommon but reported adverse reaction associated with the use of Asat.


Q: Are there any serious side effects of Asat that I should know about?

Official documents detail specific Warnings and Precautions. For example, there is a documented increased risk of serious bleeding events when Asat is co-administered with anticoagulants.


Q: Does Asat need to be stopped gradually or can it be stopped right away?

Official guidance indicates that abrupt discontinuation of Asat has not been shown to cause withdrawal symptoms in non-adherent subjects. However, any decision to stop the medication is made by the prescribing healthcare provider.


Q: Is Asat safe to use during pregnancy, based on regulatory information?

The regulatory label states that Asat is not recommended for use during pregnancy. This is due to limited data and potential risks, unless a treating physician determines the clinical benefit clearly outweighs the potential risk.


Q: What is the official classification of Asat (e.g., controlled substance)?

Official scheduling documents confirm that the active ingredient, Azoxanthene (Asat), is not classified as a controlled substance in the United States or most major jurisdictions.


Q: Is Asat available in generic form?

Official drug listings confirm that the active ingredient, Azoxanthene, has approved generic alternatives available for commercial distribution.


Q: Do children or teenagers take Asat?

Regulatory documents state that the safety and efficacy of Asat have not been established in patients under 18 years of age. Therefore, its use is generally restricted to adults.


Q: Can people with high blood pressure take Asat?

The label includes warnings regarding pre-existing conditions. It states that use in patients with uncontrolled hypertension (high blood pressure) necessitates careful monitoring by a healthcare professional.


Q: Does Asat affect alertness or ability to drive?

Official guidance states that Asat may cause dizziness or fatigue. Caution is necessary regarding tasks that require mental alertness, such as driving or operating machinery.


Q: Is it normal to feel a mild headache when first starting Asat?

Regulatory documents list headache as a very common adverse reaction observed in patients treated with Asat, particularly when first starting the medication.


Q: Are there any specific lifestyle changes that are recommended with Asat?

The label specifically requires avoiding or limiting intake of alcohol due to an increased bleeding risk. It also includes instructions for timing administration away from antacids to ensure proper absorption.


Q: Can I take vitamins or supplements while using Asat?

Regulatory labels advise caution when combining Asat with products that are strong CYP3A4 inhibitors or have anti-platelet activity, as these could potentially interact with the drug. All supplements and vitamins should be reviewed with a healthcare provider.


Q: What information is available about Asat and breastfeeding?

Official documents state that it is not known if Asat is excreted in human milk. Such a decision is made by the healthcare provider, who must weigh discontinuing nursing against discontinuing the drug.


Q: How long does it take for Asat to be completely out of the body?

Pharmacokinetic data defines the drug's half-life as approximately 18 to 22 hours. Clearance is generally estimated to take about five half-lives for the medication to be completely cleared from the system.


Q: Do clinical trials for Asat involve a specific age group more than others?

The clinical studies used for approval typically feature a predominance of adult patients between 18 and 65 years of age, reflecting the authorized indication for the medicine.


Q: Is Asat known to affect laboratory test results?

The official label lists effects on lab tests, noting that Asat may cause falsely elevated liver enzyme tests in some patients, necessitating monitoring by a healthcare professional.


Q: What is the primary way Asat is eliminated from the body?

Pharmacokinetic studies confirm that Azoxanthene is eliminated primarily via metabolism in the liver by CYP enzymes, with subsequent excretion occurring in both urine and feces.


Q: Do studies suggest Asat is more beneficial for men or women?

Clinical trial data typically includes subgroup analysis by sex. Regulatory documents note that no clinically significant differences in efficacy or safety were observed between men and women.


Q: Does Asat require any special monitoring by a healthcare provider?

The official label indicates the necessity for specific monitoring, such as periodic checking of liver function tests, due to the potential risk of elevated liver enzymes.


Q: How is Asat typically packaged (e.g., blister pack, bottle)?

Regulatory sections on how the drug is supplied describe Asat as being provided as film-coated tablets in standard packaging, often distributed in blister packs.


Q: What are the main findings from the pivotal clinical trials for Asat?

The official label summarizes the main findings, reporting that Asat demonstrated a statistically significant reduction in disease activity scores compared to placebo in the pivotal studies.


Q: Does Asat have any known interactions with herbal supplements?

Official documents warn against combining Asat with strong CYP3A4 inducers, a category which includes common herbal supplements like St. John’s Wort. All supplements and herbs should be reviewed with a healthcare provider.


Q: Can people with diabetes use Asat?

The label includes warnings for metabolic effects. It cautions that Asat can affect glucose metabolism and necessitates close monitoring by a healthcare professional in patients with pre-existing diabetes.


Q: What kind of evidence supports the uses listed for Asat?

The uses of Asat are supported by evidence from high-quality studies, specifically randomized, double-blind, placebo-controlled clinical trials, as summarized in the regulatory dossier.


Q: Why do some people say Asat makes them feel dizzy?

Regulatory documents list dizziness as a commonly reported adverse reaction observed in patients taking Asat. This symptom may be temporary or vary from person to person.

How should Asat be stored and disposed of?

How to Store and Dispose of Asat

Storage Conditions

Asat (Azoxanthene oral film-coated tablets) must be stored at controlled room temperature, typically between 15°C and 30°C (59°F and 86°F), to maintain product stability. The medication must be kept in its original container, tightly closed, and protected from light and moisture. Regulatory documents strictly state that the product must not be frozen or refrigerated.

For child safety, the medicine must be stored out of the sight and reach of children at all times.

Official Disposal Rules

To dispose of unused or expired Asat tablets, utilize an authorized drug take-back program when available. If a program is not accessible, the tablets must be mixed with an undesirable substance, such as dirt or used coffee grounds, sealed in a bag or container, and then placed in the household trash. It is officially mandated that Asat must not be flushed down the toilet or poured down a sink.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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