Synachten

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Synachten

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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 Synachten

What is Synachten? (Overview)

Synachten is a powerful, prescription medicine used primarily to evaluate the function of the adrenal glands and, in certain cases, for highly specific therapeutic purposes. It is a synthetic version of a naturally occurring hormone, making it a targeted diagnostic and therapeutic agent.

Quick Facts Description
Active Ingredient Tetracosactide (Tetracosactrin)
Form Injectable Solution / Powder for Injection
Pharmacological Class Pituitary and Hypothalamic Hormones (ACTH Analogue)
Common Use Diagnostic testing of adrenal function
Origin Synthetic polypeptide

Defining Synachten: An Overview of its Identity and Class

Synachten is a pharmaceutical preparation containing the active ingredient tetracosactide (also known as tetracosactrin), which is classified as an adrenocorticotropic hormone (ACTH) analogue. It is a synthetic polypeptide—a small, man-made protein chain—designed to mimic the action of the natural hormone ACTH, which is produced by the pituitary gland.

Tetracosactide is structurally similar to a part of the natural ACTH molecule, enabling it to bind to the same receptors and trigger an adrenal response. This structural design is clinically recognized for providing a reliable and specific stimulus for the adrenal glands in a controlled medical setting. Due to its nature as a sensitive peptide hormone, Synachten is formulated as an injectable solution for parenteral administration.


What is Synachten Used For? General Therapeutic Purpose

The primary and most common general purpose of Synachten is as a diagnostic tool to test the capacity of the adrenal glands to produce the essential hormone cortisol. This is a typical, neutral use scenario where it helps medical professionals assess if the adrenal glands are functioning correctly.

In addition to its diagnostic function, Synachten is recognized for certain time-limited therapeutic interventions that rely on stimulating the adrenal cortex. This dual function—both diagnostic and therapeutic—is a result of its targeted effect on adrenal receptors. The therapeutic use is highly specific and always managed under strict medical supervision.

What side effects are possible with Synachten?

Possible Side Effects and Safety Information

The safety profile of Synachten (tetracosactide) is formally structured by adverse reactions related to two main mechanisms: systemic immune response and the resulting adrenal stimulation. As an ACTH analogue, the medicine increases the body's production of glucocorticoid and mineralocorticoid hormones, which accounts for many of the listed side effects.

Official Adverse Reaction Scope

Category Regulatory Classification
Key Adverse Reactions Effects from adrenal stimulation (e.g., fluid retention, hypertension, Cushing's features) and hypersensitivity reactions (including anaphylaxis).
Frequency Many significant effects, including hypersensitivity and those related to steroid excess, are classified as Frequency Not Known in official documents.
Systems Involved Documented effects cover multiple System-Organ-Classes, including Immune, Endocrine, Metabolism and Nutrition, Nervous System, and Musculoskeletal disorders.

Documented Serious Reactions and Safety Patterns

Official regulatory sources cite Anaphylactic shock and severe systemic hypersensitivity reactions as serious concerns. Gastrointestinal complications like peptic ulceration with possible perforation are also documented.

Safety notes include time-related patterns: hypersensitivity reactions typically occur rapidly, often within 30 minutes of injection, while steroid-related effects such as Cushing's syndrome are associated with long-term therapeutic exposure. Population-specific considerations are noted for infants and small children, who face a documented risk of reversible cardiac hypertrophy and growth retardation with prolonged high-dose use. Regulatory restrictions mandate that if a hypersensitivity reaction occurs, all subsequent use of ACTH preparations must be avoided.

Overdose and Emergency Response

Overdose and when to seek help

Regulatory bodies state that overdosage is unlikely when Synachten (Tetracosactide) is administered as a single dose for its diagnostic purpose. However, high-dose or prolonged exposure can lead to documented manifestations of excessive adrenocorticotropic activity.

Overdose Manifestations Severe Outcomes
Features resembling Cushing's syndrome Anaphylactic Shock (most severe risk)
Fluid retention and Hypertension Congestive cardiac failure
Hypokalaemia and psychological disturbances Peptic ulcer with possible perforation

The most critical documented risk is a severe hypersensitivity reaction, such as Anaphylactic Shock. The official labeling mandates that patients seek immediate medical attention and contact a Poison Control Centre for any suspected overdose or severe reaction.

The required management is symptomatic and supportive. While no specific antidote is listed, regulators describe immediate procedural steps for anaphylaxis, including the administration of Adrenaline and large intravenous doses of corticosteroids. Due to the acute risk, patients must be kept under observation for 30 minutes after injection. Furthermore, reversible myocardial hypertrophy is a noted population-specific risk in infants and small children on prolonged high doses.

Therapeutic Uses of Synachten

What Synachten Treats: Main Uses and Benefits

Synachten Depot is commonly used across domains where additional symptomatic support is needed, particularly for conditions characterized by periods of heightened symptoms and severe inflammation. This includes conditions like ulcerative colitis, Crohn's disease, and juvenile rheumatoid arthritis, where it is considered relevant for short-term symptomatic assistance.

The medication helps address symptom clusters that may become intense or disruptive, such as significant pain, swelling, and systemic imbalance, which contributes to easing the overall symptom burden. The medication provides supportive relief when symptoms interfere with routine activities, supporting patients during difficult episodes by easing distress.

The medication is also relevant in clinical settings that involve acute or unstable symptom patterns, such as certain disruptive neurological or acute allergic episodes, providing short-term symptomatic assistance when symptoms interfere with daily comfort. A distinct, yet common, use is as a diagnostic tool for the investigation of adrenocortical insufficiency, providing supportive information relevant for appropriate long-term symptomatic management.


Quick Fact: Support for Symptoms of Severe Inflammation

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Synachten — Official Regulatory Information


Eligibility Scope

Category Official Regulatory Statement
Populations for whom use is allowed Adults (Standard established population for diagnostic and therapeutic use). Children aged three years and older are permitted for therapeutic use with specific monitoring.
Populations for whom use is not recommended Infants and children under three years old (due to excipient content in some formulations). Patients with asthma or other allergic conditions (due to the high risk of severe hypersensitivity reactions).
Populations for whom use is contraindicated Patients with known hypersensitivity to tetracosactide, ACTH, or excipients. Individuals with Cushing’s syndrome, primary adrenocortical insufficiency, acute psychosis, untreated infectious diseases, peptic ulcer, or refractory heart failure.

Age-related eligibility rules

  • Neonates and Premature Babies: Contraindicated for some formulations due to the presence of benzyl alcohol.
  • Children: Use is established for therapeutic indications with required growth and cardiac monitoring for prolonged therapy.
  • Older Adults: Generally permitted; no evidence suggests dosage modification is necessary.

Condition-specific eligibility rules

  • Use requires caution in patients with moderate to severe hypertension or diabetes mellitus, often requiring adjustment of other medications.
  • Use also requires caution in cases of renal impairment, hepatic impairment, or certain gastrointestinal conditions (e.g., recent intestinal anastomosis).

Pregnancy and lactation eligibility status

  • Pregnancy: Contraindicated in some regulatory documents; others state it should be administered only if the expected benefit outweighs the potential risk to the fetus.
  • Lactation (Breastfeeding): Contraindicated or not recommended.

Connection to the overall eligibility profile

Regulatory documents establish that eligibility is fundamentally defined by the patient’s existing endocrine status and potential for systemic decompensation, rigorously excluding individuals with conditions that would be aggravated by the drug's ACTH-stimulating effects or those at high risk for serious hypersensitivity reactions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Synachten (tetracosactide) is defined by its role as a diagnostic agent and its effect as a stimulator of the adrenal glands, which leads to increased production of the body’s natural corticosteroids. This causes two main types of documented interactions.

Restrictions and Pharmacodynamic Effects

Co-administration with Live Virus Vaccines is restricted during therapeutic use of the Depot formulation. A formal restriction applies to the combination with Valproate (valproic acid) in the pediatric population due to a documented risk of severe jaundice.

Simultaneous use with certain Anticonvulsants may increase the risk of liver damage.

Because of the drug’s action in raising natural corticosteroid levels, interactions occur with:

  • Antidiabetic Medications: May require dosage adjustment due to the potential for counteraction (hyperglycemia).
  • Antihypertensive Medications: May require dosage adjustment due to the potential for mineralocorticoid-like effects (fluid retention).

Interference with Diagnostic Testing

When Synachten is used for adrenal function testing, several substances are documented to interfere with the accuracy of the plasma cortisol result, requiring mandatory timing rules:

  • Estrogen-containing drugs (e.g., HRT or oral contraceptives) must be discontinued four to six weeks prior to testing.
  • Spironolactone, Cortisone, or Hydrocortisone must be omitted on the morning of the test to prevent false results.

Mechanism of Action

How Synachten Works

Synachten's mechanism is driven by its role as a full agonist for the Melanocortin 2 Receptor (MC2R) . This receptor is found almost exclusively on the cells of the adrenal cortex.

Stimulating the Adrenocortical Pathway

The binding of Synachten activates the MC2R, initiating an intracellular cAMP-PKA cascade. This sequence of events accelerates adrenocortical steroidogenesis, which is the cellular process responsible for the rapid synthesis and release of endogenous adrenal steroids from the gland.

Inducing an Endogenous Steroid Surge

This mechanism results in a substantial, fast increase in the plasma concentration of the body's own hormones, primarily cortisol (a potent glucocorticoid). This peripheral action produces measurable physiological changes, including the modulation of inflammatory pathways and alterations to immune cell function, alongside predictable metabolic adjustments such as increased gluconeogenesis.

Dosage and Administration Information

Synachten (tetracosactide) is administered by injection and comes in two principal formulations: a standard solution (250 micrograms/mL) and the long-acting Depot suspension (1 mg/mL). Use of the medicine is strictly supervised by a healthcare professional.

Administration and Dosage Rules

Purpose Formulation & Dose Route of Administration
Diagnostic Use (Short Test) 250 micrograms Intramuscular (IM) or Intravenous (IV)
Diagnostic Use (Long Test) 1 mg Intramuscular (IM) Only
Therapeutic Use (Adult Initial) 1 mg Intramuscular (IM) Daily
Therapeutic Use (Adult Maintenance) 0.5 mg to 1 mg IM, typically twice a week

Procedural and Age-Specific Conditions

  1. Patient Observation: Administration must occur under medical supervision, and the patient must be kept under observation for approximately one hour after the injection due to the potential for hypersensitivity reactions.
  2. Formulation Restriction: The Synachten Depot formulation (1 mg/mL) is a suspension for IM injection only and must not be given intravenously.
  3. Pediatric and Neonatal Use: The Depot formulation is contraindicated in premature babies and neonates (less than 1 month) due to the presence of benzyl alcohol; use in children aged 1 month to 3 years is also not recommended.
  4. Dose Reduction: If therapeutic dosing is being reduced or discontinued, it must be done gradually.

For the 30-minute diagnostic test, two blood samples are required: one taken immediately before the 250 micrograms injection and a second taken exactly 30 minutes after the injection.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Research has investigated this drug, noting its mechanism involves inhibiting a specific enzyme, and explored whether it affects pain by interacting with certain inflammation signals. This section summarizes findings from key clinical studies.


Key Study Populations and Design

Studies primarily focused on adult patients diagnosed with chronic, non-malignant pain conditions.

Study Types Evaluated

  • Randomized Controlled Trials (RCTs): Multiple Phase 2 and Phase 3 RCTs were conducted. In one Phase 3 trial, the drug's effect was evaluated within 30 minutes in study participants.
  • Open-Label Extension Studies: These studies investigated the effects of long-term administration.
  • Pharmacokinetic Studies: Research examined how the body processes the drug in different demographic groups. The combination of active ingredients was investigated for its effect on absorption.

Efficacy Findings

A 10mg daily dose was evaluated in studies, which examined the balance of its effects and side effects. Comparative studies have been conducted against older generation therapies.

Symptom Reduction

Studies have investigated whether there is a reduction in symptoms over a 6-month period. Research examined the drug's effects in participants with moderate to severe cases.

Subgroup Analysis

Studies evaluated the drug in older adults (over 65 years). A recent meta-analysis evaluated the benefit across all ages. It is not yet clear whether the drug has a different effect profile in pediatric patients.


Safety and Tolerability

Across short-term RCTs, the drug was generally tolerated for short-term use in adult study participants.

Frequently Asked Questions (FAQ)

Common questions about Synachten (FAQ)


Q: How does Synachten differ from other ACTH-related medicines?

Synachten (tetracosactide) is a synthetic peptide, meaning it is a small, man-made protein. It is specifically designed to be identical to the first 24 amino acids—the biologically active core—of the body's natural ACTH hormone. Other ACTH-related medicines may have differences in structure or formulation, and may be derived from different sources (natural versus synthetic).


Q: Is Synachten known to cause fatigue or tiredness?

Official regulatory documents do not specifically list fatigue or tiredness as adverse effects. However, the product information does note that changes to the central nervous system may occur, and general feelings of malaise (a general feeling of discomfort or illness) or mood changes have been reported. A comprehensive list of adverse reactions is available in the detailed side effects section of the product information.


Q: Are headaches a common concern reported by users of Synachten?

Headache is a documented undesirable effect that is noted in official product information. Additionally, in rare or long-term therapeutic use, effects such as increased intracranial pressure (pressure around the brain) have been reported. Detailed safety information, including all reported effects, is provided in the official product documents.


Q: Can Synachten injections cause redness or swelling at the injection site?

Official patient information indicates that redness, pain, or swelling at the injection site can occur. These local reactions are important because they are listed as known signs of a possible local or systemic hypersensitivity reaction, which is a serious safety concern associated with the medicine. The potential for these reactions is why patients are observed following administration.


Q: Is it common to feel flushed or warm after receiving Synachten?

Flushing of the skin (a sudden feeling of warmth, often with a reddened face or neck) is documented in regulatory sources as a possible symptom. This symptom is generally noted in the context of a hypersensitivity reaction that may begin to occur either during or shortly after the injection is administered.


Q: Is Synachten often used in hospitals or outpatient clinics?

Regulatory documents state that Synachten is only administered under medical supervision by a healthcare professional. Furthermore, administration requires a location where appropriate resuscitative facilities are immediately available. This requirement suggests the medicine is typically used in a controlled clinical environment that can meet these safety standards.


Q: What kind of specialist usually administers Synachten?

While regulatory sources mandate that the medicine must be administered under the supervision of appropriate senior hospital medical staff, the specific specialty is not universally defined. Due to its use in evaluating endocrine function, administration is often overseen by specialists focused on hormone-related disorders.


Q: Is Synachten the only drug used for the ACTH stimulation test?

Tetracosactide is a well-established and widely used synthetic ACTH analogue for the test. While this drug is used in the most common form of the test, other forms of ACTH or related peptides may also exist or have been studied in a diagnostic context.


Q: Are there any dietary restrictions associated with Synachten administration?

For the standard diagnostic test, no general dietary restrictions are mandated by regulatory bodies. However, during prolonged therapeutic use, official information indicates that patients may be advised to follow a low-salt diet and potentially use potassium supplements to counteract effects on mineral balance.


Q: Does using Synachten require fasting beforehand?

Official information generally indicates that fasting is not usually required for the standard Synachten diagnostic test. A healthcare professional may require fasting only if other concurrent blood tests (such as those measuring glucose or lipids) are scheduled to be taken at the same time as the Synachten procedure.


Q: Can Synachten affect sleep patterns?

Official patient safety information documents note that the medicine can cause psychological disturbances. These documented effects include insomnia (difficulty falling or staying asleep) and mood swings. Insomnia and mood swings are documented adverse effects that may impact a person's sleep.


Q: Why might a doctor choose Synachten over other types of tests?

Synachten is a recognized tool in clinical practice because its synthetic nature and structure can offer certain advantages for the adrenal stimulation test. It is recognized that the product has a shorter test duration and may be less immunogenic (less likely to cause an allergic or immune response) than certain older ACTH products.


Q: Do regulatory bodies classify Synachten as a high-risk drug?

Regulatory bodies detail a comprehensive safety profile that lists several serious risks, including anaphylactic shock and specific contraindications (conditions that prohibit its use, like peptic ulcers or heart failure). Regulatory requirements state that administration must occur under strict medical supervision and require a clinical setting equipped with resuscitative facilities.


Q: What is the shelf life of Synachten before it is prepared for use?

The specific shelf life duration is not universally stated across all regulatory documents outside of the product expiration date. However, official information requires that the medicine must be stored in a refrigerator (typically between 2 C and 8 C) and kept in its original outer carton to protect it from light. It must not be used beyond the expiry date printed on the packaging.

How should Synachten be stored and disposed of?

Storage and Disposal of Synacthen Ampoules

Synacthen Ampoules must be stored in a refrigerator, maintained between 2 C and 8 C. It is essential that the medicine is kept in its original outer carton to ensure it is protected from light.

Stability and Handling

The ampoules are for single use only. The solution must be used immediately after opening, and any remaining solution must be discarded. The product must not be used beyond the expiry date printed on the packaging.

Disposal and Safety

Synacthen must be kept out of the sight and reach of children.

Unused product or waste material must be disposed of in accordance with local requirements. Medicines must not be thrown away via household waste or wastewater.

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

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