Ypozane

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Ypozane

Method of action: Urologicals

Treatment option:

Medically reviewed

Rosario Oropesa

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 Ypozane

Quick Facts

Property Description
Active Ingredient Osaterone Acetate
Form Tablet (chewable)
Pharmacological Class Steroidal Antiandrogen and Potent Progestagen
Target Species Male Dogs (Specifically entire dogs)
Origin Synthetic Steroid

What Type of Veterinary Medicine is Ypozane?

Ypozane is a Veterinary Medicinal Product defined by its single active ingredient, Osaterone Acetate. This compound is a synthetic steroid belonging to the Steroidal Antiandrogen and Potent Progestagen pharmacological class. It is supplied as a chewable tablet for oral use in male dogs, which is a unique formulation intended to simplify administration. This chemical classification provides the basis for its targeted mechanism of action, making it a specific tool for hormonal modulation in its intended species.

Osaterone Acetate: Its Classification and Action

The compound Osaterone Acetate primarily functions as an Androgen Receptor Antagonist, a mechanism that directly interferes with hormone signaling. This action involves the molecule competitively occupying and blocking the androgen receptors on cells, physically preventing natural male hormones like Testosterone and its potent metabolite, dihydrotestosterone (DHT), from binding to the target tissues. This mechanism ensures that the hormonal signal cannot be transduced, functioning as an effective inhibitor of overstimulation in androgen-dependent tissues. The compound has potent anti-androgenic activity and a high affinity for androgen receptors.

General Therapeutic Purpose of This Anti-Androgen

The general therapeutic purpose of this medication is to act as a hormonal regulatory agent to counteract the excessive influence of male hormones in male dogs. This is particularly useful in scenarios where a rapid, non-surgical method is preferred for controlling androgen-driven issues in entire dogs. By utilizing its targeted ability to block androgen binding, Ypozane addresses the core hormonal drive behind certain androgen-dependent conditions. The drug is designed to help manage issues caused by excessive male hormone influence.

What side effects are possible with Ypozane?

Possible Side Effects and Safety Information

The official safety profile for Ypozane (Osaterone Acetate) is defined by classified adverse reactions that primarily involve transient effects on the endocrine and metabolic systems.

Frequency of Adverse Reactions

Adverse reactions are classified in regulatory documents according to frequency:

Classification Examples of Documented Adverse Reactions
Very Common (>1 in 10) Transient increase in appetite, transient reduction of plasma cortisol concentration (hypocortisolaemia).
Common (1 to 10 in 100) Transient behavioural changes (e.g., shifts in activity level).
Uncommon (1 to 10 in 1,000) Transient vomiting and/or diarrhoea, lethargy, increased thirst (polydipsia), increased urination (polyuria), and mammary gland hyperplasia.
Very Rare (<1 in 10,000) Transient decrease in appetite, hair coat changes, and galactorrhoea.

Safety Constraints and Special Considerations

The majority of documented side effects are categorized as transient; however, the reduction of plasma cortisol concentration may persist for several weeks following administration.

Safety precautions are specifically noted for certain physiological states:

  • Hepatic Status: Caution is advised for animals with a history of liver disease, as clinical trials noted a reversible elevation of liver enzymes (ALT and ALP) in some cases.
  • Physiological Stress: Due to the risk of hypocortisolaemia, appropriate monitoring is necessary for dogs under stress (e.g., post-operative) or those with existing hypoadrenocorticism.
  • Diagnostic Interference: The medication is documented to suppress the response to an ACTH stimulation test for a period of several weeks after treatment.

The official product information states that no interactions with other medicinal products are known.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents for Ypozane (Osaterone Acetate) define the drug's overdose profile based on controlled studies and specific public health requirements.


Documented Overdose Findings

Overdose studies conducted in the target species (male dogs) at high dose levels resulted in no undesirable clinical effects being observed. The sole officially documented physiological finding associated with this exposure was a measurable decrease of cortisol plasma concentration. The regulatory documentation does not list a specific antidote for Osaterone Acetate overdose; consequently, management would be symptomatic and supportive.


Emergency Action and Required Help-Seeking

Immediate emergency action is explicitly required for accidental human exposure. If a person accidentally ingests the tablet, the official guidance mandates that medical advice be sought immediately. The person must also show the package leaflet or the label to the attending physician, as stipulated by regulatory authorities. Exposure in non-target female laboratory animals was associated with serious adverse effects on reproductive functions. Urgent medical help is therefore mandated specifically for human ingestion, though severe clinical outcomes in the dog were not reported at tested overdose levels.

Therapeutic Uses of Ypozane

What Ypozane Treats: Main Uses and Benefits

Ypozane (Osaterone Acetate) is used for managing Benign Prostatic Hypertrophy (BPH) in entire male dogs, a condition presenting with localized discomfort. The medication is used to address specific distressing symptoms associated with this condition. The primary therapeutic focus is on alleviating the clinical signs that interfere with daily functioning. It is applied when additional symptomatic support is needed to manage symptom clusters that may become intense or disruptive.

This medication may help address symptoms such as difficulty in urination (dysuria), the presence of blood in the urine (hematuria), and straining during defaecation (constipation). The use of this antiandrogen supports the patient during difficult episodes by easing distress associated with the enlarged prostate. The medication is commonly used in clinical settings that involve acute or unstable symptom patterns. It is relevant when short-term symptomatic assistance is needed and may assist with maintaining functional stability.

Quick Fact: Relief for Pressure Symptoms
Primary Indication: Benign Prostatic Hypertrophy (BPH)
Symptom Focus: Lower Urinary Tract Impairment & Gastrointestinal Pressure
Main Benefit: Reduction of prostate volume, which supports the easing of physical discomfort.
Context: Non-surgical management in entire male dogs.

Regulatory References

  1. European Commission Summary of Product Characteristics

Eligibility and Restrictions for Use

Who Can and Cannot Use Ypozane?

Eligibility for Ypozane (Osaterone Acetate) is strictly defined by regulatory documents for its approved use in a specific population.

Official Eligibility Scope

Category Regulatory Status
Target Species & Status Entire male dogs with Benign Prostatic Hypertrophy (BPH)
Absolute Contraindications None are explicitly listed in the official Summary of Product Characteristics for the target species
Age Restriction Implicitly restricted to sexually mature, adult, and older dogs
Weight Restriction Use is not established in dogs with a bodyweight less than 3 kg

Conditional Use and Restrictions

Official labeling requires specific considerations for certain health conditions. Use requires caution in male dogs with a history of liver disease, as the safety of Ypozane has not been fully investigated in this population. Additionally, appropriate monitoring must be implemented for dogs with conditions such as hypoadrenocorticism or those under acute stress, as specified in regulatory documents. Treatment is strictly limited to the approved indication and patient profile.

What should I know about interactions with other medicines?

Interactions with other Medicines and Products

This section outlines the officially documented interaction profile for Ypozane (Osaterone Acetate) based on authoritative government regulatory information. This information is purely descriptive and non-advisory.

Official Interaction Statements

Regulatory documentation explicitly states that no interactions are known between Osaterone Acetate and other medicinal products. The primary structure of the official interaction profile is characterized by the absence of specific warnings related to co-administration.

Interaction Type Documentation Status
Drug-Drug Interactions None known or specifically listed
CYP Enzyme/Transporter Effects No specific interacting mechanisms are documented
Food or Herbal Interactions None known

Population-Specific Interaction Notes

While not a drug-drug interaction, a special precaution noted in the label is the use with caution in animals with a history of liver disease. The safety of Osaterone Acetate in this specific population has not been thoroughly investigated.

Co-Administration Context

The regulatory information allows for the concurrent administration of Ypozane with antimicrobials when treating Benign Prostatic Hypertrophy (BPH) associated with prostatitis. This allowance indicates that this common combination does not necessitate an interaction-related restriction.

Mechanism of Action

Ypozane (osaterone acetate) acts through two complementary pharmacological mechanisms to modulate the androgen-dependent physiological cascade. The primary mechanism involves its active metabolite acting as an anti-androgen that competitively binds to the androgen receptor. This competitive blockade prevents the interaction of endogenous androgens (such as testosterone and dihydrotestosterone) with their cellular receptors, thereby decreasing androgenic stimulation of targeted tissues. The secondary mechanism involves osaterone acetate inhibiting the activity of the enzyme 5alpha-reductase. This enzyme is responsible for the intracellular conversion of testosterone to dihydrotestosterone (DHT) in peripheral tissues. This dual action results in a reduction of circulating levels of active androgens. The overall system-level effect is the modulation of the androgen-dependent cascade through both receptor antagonism and enzyme inhibition, an action that is independent of the hypothalamic-pituitary-gonadal axis (HPGA).

Dosage and Administration Information

How to use Ypozane

Ypozane (Osaterone Acetate) is administered exclusively through the oral route as part of a single, defined treatment protocol. The standardized regimen involves giving one tablet once daily for a continuous course of seven days. The precise dose is determined by the patient's body weight, falling within the range of 0.25 to 0.5 mg of osaterone acetate per kilogram. The fixed-dose tablets are available in multiple strengths, which correspond to specific weight bands to ensure administration aligns with the established daily dose limits.

A core principle of this drug’s use is the fixed duration of therapy. The seven-day course constitutes the complete treatment, and the maximum dose must not be exceeded during this time. Regarding intake conditions, the tablet can be administered either directly into the mouth or mixed with food.

The use protocol is not continuous or long-term. The effects of a single course are expected to provide a clinical response that persists for a minimum of five months. Consequently, the protocol mandates a veterinary re-evaluation after the 5-month interval, or sooner if clinical signs recur. The established protocol restricts use to male dogs weighing 3 kg or more.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Ypozane (Osaterone Acetate)


Evidence for Use in Benign Prostatic Hypertrophy (BPH)

Osaterone Acetate was studied in the context of clinical signs related to Benign Prostatic Hypertrophy (BPH) in entire male dogs. The primary evidence used to evaluate this medication is derived from short-term, randomized and controlled clinical field trials (RCTs) and non-controlled studies. These studies were applied in research contexts involving conditions where symptoms may vary in intensity and are marked by functional limitations such as difficult urination and straining.

Findings from the research describe patterns observed in the measured changes of the prostate gland size. Research examined measurements taken via ultrasonography before and after treatment. Studies also reported how symptoms evolved in the observed populations, specifically focusing on outcomes related to physical discomfort and functional imbalance linked to the enlarged prostate.


Study Outcomes and Measures Examined

Researchers monitored two main sets of outcomes. The first was the physical change in the prostate, where ultrasound measurements were used in research exploring changes in the prostate volume. The second set of outcomes involved monitoring clinical scoring systems for outcomes related to physical discomfort and function. These scores were used in research exploring how symptoms change over time.

Studies also monitored the level of the canine-specific biomarker Prostate Specific Esterase (CPSE), which is an outcome linked to prostate activity, helping to contextualize findings related to the overall change in the prostate gland.


Duration of Effect and Follow-up Periods

Clinical trials primarily focused on research exploring short-term symptom changes, with initial assessments often occurring within seven to twenty-eight days. The studies then monitored the dogs over an intermediate-term period, typically lasting up to five to six months (up to 24 weeks).

Research examined the time until a second course of treatment was necessary. The study findings indicate that the observed status may be temporary. This observation period was evaluated in order to describe the persistence of the observed clinical status before the recurrence of BPH signs, which contributes to understanding short-term changes.


Evidence Gaps and Areas of Research Uncertainty

While evidence includes multiple controlled trials regarding the short-to-intermediate term effects, long-term effects are not fully established. There is limited information for long-term outcomes regarding the continued use of Osaterone Acetate over multiple years, particularly when comparing its use to permanent interventions like surgical castration.

The sample sizes were modest in some of the individual trials used in the evidence base, meaning that results apply only to the populations studied and may not fully generalize to all dogs. Furthermore, comparative evidence in this area remains limited for certain long-term comparisons. This research provides context, but the study findings describe group patterns, and are not a substitute for individual predictions.

Frequently Asked Questions (FAQ)

Common questions about Ypozane (FAQ)


Q: How soon after starting Ypozane might a dog owner see improvement in BPH symptoms?

Clinical response to the treatment, such as improvement in symptoms related to Benign Prostatic Hypertrophy (BPH), is typically observed within two weeks of starting the seven-day regimen. The owner may observe signs of improvement during this period. According to official product information, the effect of one course is expected to last for at least five months.


Q: Why is Ypozane generally not recommended for dogs with known liver issues?

The product information advises caution for dogs with a known history of liver disease. This is because the safety of the medicine has not been fully investigated in this specific population. Reversible elevation of liver enzymes (ALT and ALP) was observed in some dogs during the clinical trials.


Q: Does Ypozane affect the dog's adrenal glands?

Official information indicates that the medication may cause a transient reduction of plasma cortisol concentration (hypocortisolaemia). This reduction can persist for several weeks after the administration period. Due to this possibility, monitoring is specified for dogs with conditions like hypoadrenocorticism or those under acute stress.


Q: Can Ypozane be given alongside other common dog supplements?

Regulatory documents state that no interactions are known between the active ingredient, Osaterone Acetate, and other medicinal products. Furthermore, official information does not list any known interactions with food or herbal substances. Information regarding all supplements received by the dog is typically provided to the veterinarian.


Q: What are the signs that a dog's BPH is not responding to Ypozane treatment?

The expected clinical response from one course of treatment is designed to persist for a minimum of five months. If the clinical response is considerably shorter than this expected duration, the official protocol mandates a re-evaluation of the diagnosis by the veterinarian.


Q: How does Ypozane compare to other BPH treatments in terms of long-term use?

Official evidence is primarily focused on short- to intermediate-term effects. The regulatory documentation notes that the long-term effects of the drug are not fully established and that the observed duration of effect from a single course is at least five months. The product is not intended for continuous, long-term use without veterinary re-evaluation.


Q: What is the maximum number of times a dog can be treated with Ypozane in a year?

The clinical effect of one course persists for a minimum of five months. Retreatment can only be considered after five months have passed or if clinical signs return, following a complete veterinary re-evaluation and risk-benefit assessment. The official protocol mandates a minimum five-month interval between courses.


Q: Why is the treatment course for Ypozane only seven days?

The seven-day treatment protocol is established because the medication has a slow elimination half-life and is designed to accumulate in the body over the course of the week. This short administration period allows the drug to achieve and maintain its therapeutic concentration, resulting in an anti-androgenic effect that persists for months.


Q: Does Ypozane affect a dog's fertility or ability to stud?

Official regulatory documentation provides a specific safety finding regarding reproductive function. It reports that no adverse effects on semen quality have been observed in male dogs treated with this product.


Q: Is Ypozane considered a prescription-only medication in most places?

Yes, in many jurisdictions, including the UK, the regulatory classification for this product is POM-V, which stands for Prescription Only Medicine – Veterinarian. This means the product is restricted and can only be obtained and administered with a veterinary prescription.


Q: Why do some veterinarians suggest Ypozane as an alternative to castration for BPH?

The product is suggested as an alternative primarily because of its specific mechanism of action as an anti-androgen that treats BPH without surgical intervention. Furthermore, official safety data reports that no adverse effects on semen quality have been observed, supporting its use when preserving reproductive potential is necessary.


Q: Does Ypozane affect the quality or volume of a dog's semen?

Official regulatory documentation specifically addresses this concern. It states that no adverse effects on semen quality have been observed in male dogs that have been treated with this product.


Q: Can Ypozane be used to treat other conditions besides an enlarged prostate?

The regulatory indication for use is explicitly defined as the treatment of benign prostatic hypertrophy (BPH) in male dogs. This limits the official, approved use of the medication to this specific condition.


Q: Does Ypozane contain lactose or other inactive ingredients that owners should know about?

Yes, the product is a chewable tablet and contains a specific list of excipients (inactive ingredients) in addition to the active drug. The official product characteristics list Lactose monohydrate among these excipients, alongside others like maize starch and magnesium stearate.


Q: Where can a dog owner find the official package insert for Ypozane?

The complete, detailed product information, known as the Summary of Product Characteristics (SmPC) or package leaflet, is officially published online. This document is typically found on the website of the relevant veterinary medicinal product authority, such as the European Medicines Agency (EMA) or national regulatory bodies.

How should Ypozane be stored and disposed of?

Storage and Disposal of Ypozane: Official Regulatory Requirements

The official regulatory documentation for Ypozane (osaterone acetate) states that the product does not require any special storage conditions, such as specific temperature, light, or moisture controls. The labeled shelf-life of the tablets is three years when kept in their original aluminium/aluminium blister packaging.

Mandatory Storage and Disposal Rules

Item Requirement
Child Safety Must be stored out of the reach and sight of children.
Disposal Unused product or waste must be disposed of in accordance with local requirements, often advising the use of take-back schemes to protect the environment.

These rules ensure the stability of the product and compliance with mandatory environmental safety protocols.

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

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