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Growth hormone

Macimorelin, explained simply

FDA-approved diagnostic test for adult growth hormone deficiency.

Well studied in peopleTaken by mouth5 cited sources

Start here

What is Macimorelin?

Macimorelin, sold as Macrilen, is an FDA-approved oral test — not a treatment — for diagnosing growth hormone deficiency in adults 5. A single dose prompts the pituitary (the master hormone gland at the base of the brain) gland to release growth hormone, and blood tests then show whether the gland can respond 5. It replaced a riskier method, the insulin tolerance test, which can cause dangerously low blood sugar 1.

How it works in your body

Macimorelin imitates ghrelin, a hormone your body makes, and docks onto ghrelin's receiving sites in the brain and pituitary (the master hormone gland at the base of the brain) gland. That docking tells the pituitary to release a burst of its own growth hormone. Doctors use the response as a test: if the pituitary cannot produce a strong burst even when directly told to, that confirms growth hormone deficiency 5.

Why researchers care

Macimorelin is approved only for diagnosing adult growth hormone deficiency — it is a test, not a treatment. 5 Its advantage is that it is taken by mouth and replaces the older insulin tolerance test, which can push blood sugar dangerously low. 1

The deeper mechanism, for the curious

Macimorelin makes the body release growth hormone (GH) by activating growth hormone secretagogue (a compound that prompts your body to release growth hormone) receptors (docking sites that signal GH release) in the pituitary (the master hormone gland at the base of the brain) and hypothalamus (the gland and brain area that control hormones). 5 Blood levels peak 0.5–1.5 hours after a dose by mouth, and GH peaks 30–90 minutes after dosing, so blood is drawn at 30, 45, 60 and 90 minutes. 5 A maximally stimulated GH below 2.8 ng/mL confirms adult GH deficiency. 5 The body breaks it down mainly with CYP3A4 (a liver enzyme), and its mean terminal half-life (the time for half the drug to leave the body) is 4.1 hours. 5 A liquid meal cut its Cmax (peak blood level) by 55% and its AUC (total amount absorbed) by 49%, so it is given after at least an 8-hour fast. 5 Because it acts downstream of the hypothalamus, it can miss GH deficiency early in hypothalamic disease. 5

Evidence check

Well studied in people

This has been through large human trials — the strongest kind of evidence. Scientists have tested it on many people and measured what actually happened.

Every numbered marker on this page links to one of the 5 sources at the bottom.

95/100

Test Accuracy

Macimorelin achieves 87% sensitivity and 96% specificity for AGHD diagnosis with 97% reproducibility on retesting, providing highly reliable results for clinical decision-making.

94/100

Safety & Tolerability

No serious adverse events reported in Phase 3 trials, QT prolongation is mild (~11 msec), and common side effects are transient and mild, making it suitable for broad patient populations.

93/100

Convenience & Patient Experience

A single oral dose avoids the injections and low blood sugar of the insulin tolerance test, with blood drawn over 90 minutes (at 30, 45, 60 and 90 minutes).

What the research points to

The most-asked question

How much Macimorelin do I take?

The research-reported range is 0.5 mg/kg, as needed.

  1. Adult growth hormone deficiency diagnosis

    0.5 mg/kg

    • How often
      Single dose
    • For how long
      One-time diagnostic test
    • How
      By mouth

    FDA-label (Macrilen) single oral dose for diagnosing adult growth hormone deficiency. Granules (60 mg) are reconstituted in 120 mL water (0.5 mg/mL) and taken after an 8-hour fast; serum GH below 2.8 ng/mL across the 30/45/60/90-minute draws confirms deficiency 4.

Adjusting your dose

You're at the right dose if…

Consider going up if…

  • Initial test is inconclusive and retesting is clinically indicated
  • Patient weight changes significantly between test administrations
  • Clinical suspicion remains high despite initial negative result

Go down if…

  • Not applicable — single fixed dose based on weight
  • Dose is calculated once at 0.5 mg/kg body weight

The ceiling: 0.5 mg/kg as a single oral dose; patients over 120 kg need two 60 mg pouches dissolved in 240 mL of water 5

Reconstitution, in plain words

How do I mix Macimorelin?

Peptides usually arrive as a freeze-dried powder in a small vial. “Reconstitution” just means adding sterile water back in so you can measure a dose. Here's how it works for Macimorelin:

What you need

  • Macrilen powder vial (25 mg or 50 mg)
  • Sterile water for injection (pharmaceutical grade)
  • Small glass of water (8 oz) for dilution
  • Graduated cylinder or syringe for measuring
  • Small spoon or stirring device

A worked example

For a 70 kg patient: 70 kg × 0.5 mg/kg = 35 mg total dose. If using a 25 mg vial, reconstitute with appropriate volume of water to achieve desired concentration.

Working out your dose

Dose (mg) = Patient body weight (kg) × 0.5 mg/kg. Round dose to nearest mg if needed. Single oral dose dissolved in water, taken on empty stomach.

Or let the calculator do it

Three quick questions — your vial, your water, your dose — and it tells you the exact syringe mark. “Find dose amount” is preloaded with Macimorelin's recorded schedule.

MacimorelinSingle dose

How much peptide is in your bottle?

Look at the label on the vial. It’s the number next to the unit — like "5 mg". Labeled in IU? Switch the unit to IU.

Type a number to continue.
0

Timing

When do I take Macimorelin?

With or without food?

Must be taken after at least an 8-hour fast: a liquid meal lowered peak levels by 55% and exposure by 49%. 5

Taking it with other peptides

This is a single-use diagnostic test, not a compound to be stacked. Blood GH is measured at 30, 45, 60 and 90 minutes after the dose. 5 Stop GH therapy at least one week before, and avoid drugs that affect GH release. 5

The honest list

What side effects could Macimorelin cause?

Common — usually mild

These show up most often. They usually fade as your body adjusts.

  • Altered taste (dysgeusia)

    Metallic or unpleasant taste in mouth affecting 4.5% of patients. Often described as a bitter or medicinal aftertaste. Occurs within minutes of taking the dose and typically resolves within 1-2 hours.

    What to do Eat something sweet or drink a flavored beverage after the required fasting window. Swish mouth with water. Taste usually resolves spontaneously. Does not interfere with test results.

  • Dizziness

    Mild dizziness or lightheadedness in 3.9% of patients. Usually mild and transient, resolving within 1-2 hours. May be related to fasting state and GH stimulation.

    What to do Sit or lie down if dizziness occurs. Stay well-hydrated. Avoid sudden position changes. Dizziness resolves as GH levels normalize. No intervention usually needed.

  • Headache

    Mild to moderate headache in 3.9% of patients. Typically mild and non-throbbing. Occurs within first few hours after dosing. Similar incidence to placebo in some analyses.

    What to do Rest in a quiet, dark environment. Over-the-counter pain relief (acetaminophen or ibuprofen) is safe if needed. Drink plenty of water. Usually resolves within 2-4 hours without intervention.

  • Fatigue

    Mild fatigue or tiredness in 3.9% of patients. May be related to morning testing and fasting state. Typically mild and short-lived.

    What to do Schedule test when able to rest afterward. Avoid strenuous activity immediately after testing. Fatigue usually resolves within 2-4 hours. Eat a light meal after the testing window concludes.

  • Nausea

    Mild nausea in 3.2% of patients. Rarely progresses to vomiting (less than 1% of cases). Related to fasting state and GH stimulation. Transient and mild when it occurs.

    What to do Remain still and breathe deeply. Avoid sudden movements. Eat bland foods after testing window. Ginger tea or peppermint may help. Does not typically interfere with diagnostic test.

  • Increased Appetite

    Hunger or increased appetite stimulation in 3.2% of patients. Expected physiologic response since macimorelin stimulates ghrelin (the hunger hormone)/hunger pathways. Occurs during test window.

    What to do This is expected during the diagnostic test. Eat a meal immediately after the 60-minute testing window concludes. Hunger resolves once food is consumed. Does not affect test validity.

Serious — stop and get medical help

Rare, but if any of these happen, stop and contact a medical professional.

Week by week

What should I expect from Macimorelin, and when?

  1. Before Testing (Preparation)

    You might notice
    • Healthcare provider orders GH deficiency diagnostic testing
    • Informed consent obtained, QT risk assessment performed
    • Baseline lab work (electrolytes, ECG if clinically indicated)
    What's normal
    • No symptoms — baseline visit and screening
    • ECG performed to rule out QT prolongation
    • Instructions provided for fasting and test day preparation
    What's next
  2. Test Day (During Diagnostic Protocol)

    What's normal
    What's next
  3. Post-Testing (1-2 Days)

    You might notice
    • Any mild side effects have completely resolved
    • Lab results returned to healthcare provider
    • GH level compared to diagnostic cutoff (2.8 ng/mL)
    • Diagnosis confirmed: GH sufficient (negative) or deficient (positive)
    What's normal
    • Negative result (GH >2.8 ng/mL) — GH deficiency ruled out
    • Positive result (GH ≤2.8 ng/mL) — consistent with AGHD
    • 97% reproducibility if retesting needed
    What's next
    • If positive: discuss GH replacement therapy options with endocrinologist
    • If negative: investigate other causes of symptoms
    • Retest only if clinically indicated and initial results equivocal

How to tell it's actually working

Signs of Test Accuracy

How Good the Test Is

  • Patient tolerates dose well with minimal side effects
  • Adequate blood samples obtained at all timepoints
  • Clear diagnostic result (definitively positive or negative, not equivocal)
  • No technical issues interfering with sample quality

Not seeing anything? The usual reasons

Is it right for you?

Who should avoid Macimorelin?

Do not use it if…

  • Patient has QT interval prolongation or history of torsades de pointes
  • Patient is critically ill from acute medical or surgical illness
  • Patient has known hypersensitivity to macimorelin
  • Patient cannot maintain fasting state before test
  • Patient is taking multiple QT-prolonging medications
  • Patient has baseline QTc interval greater than 450 msec (males) or 460 msec (females)

Be extra careful if…

When to stop

  • Test has been completed and diagnostic results obtained (single-use diagnostic tool)
  • Patient develops signs of QT prolongation or cardiac arrhythmias
  • Patient experiences severe hypersensitivity reaction
  • Contraindications emerge that preclude continued testing
  • Physician determines additional testing is not clinically warranted

Macimorelin is a single-dose diagnostic test, not an ongoing therapy. Once administered and blood samples collected, the diagnostic protocol is complete. Additional testing requires a separate administration if clinically indicated by the healthcare provider.

What it mixes badly (and well) with

Medications

  • Avoid
    QT-prolonging drugs (quinidine, disopyramide, amiodarone, sotalol, dofetilide, antipsychotics, antiemetics)

    Raises the risk of QT prolongation (a heart rhythm change) and torsades de pointes (a dangerous irregular heartbeat). Avoid the combination or use extreme caution with ECG (heart tracing) monitoring.

  • Avoid
    Strong CYP3A4 inducers (carbamazepine, phenytoin, rifampin, St. John's wort, modafinil)

    Lower macimorelin levels and can cause a false positive result. Stop them and allow a washout (a drug-free waiting period) before testing 5

  • Avoid
    Medications affecting electrolytes (diuretics, amphotericin B)

    Electrolyte abnormalities (imbalances of body salts) raise the risk of QT prolongation. Make sure potassium (K+) and magnesium (Mg+) levels are normal before testing.

  • Avoid
    Corticosteroids or opioids

    May blunt the GH response to macimorelin. Stop them before testing if possible.

Other peptides

Supplements

  • Avoid
    Supplements affecting heart rhythm (stimulants with high caffeine)

    Extreme caffeine intake before testing may increase arrhythmia risk. Recommend abstinence 24 hours before test.

Who it tends to suit

Diagnosis of Adult Growth Hormone Deficiency

Macimorelin is FDA-approved specifically for diagnosing AGHD in adults. It replaces the insulin tolerance test (ITT) as a safer, more convenient, and equally accurate diagnostic option. Phase 3 trials showed 87% sensitivity and 96% specificity.

Patients Who Cannot Safely Have the Insulin Tolerance Test (ITT)

For patients who cannot safely undergo insulin tolerance testing due to cardiac risk, seizure history, or other contraindications, macimorelin offers an evidence-based non-invasive alternative.

Clinical Confirmation Testing

Retesting agreed with the first result in 97% of people in the published trial. 1 It is a diagnostic test only: GH therapy must be stopped at least one week before testing, so it cannot be used to monitor treatment. 5

The safety picture overall

Macimorelin is given once, as a single oral dose for a diagnostic test. In the registration trial (154 people dosed), the most common reactions were taste disturbance (4.5%), dizziness, headache and fatigue (3.9% each), and nausea and hunger (3.2% each). 5 No serious adverse events were reported for macimorelin. 1 It raises the corrected QT interval by about 11 msec; QT prolongation can lead to torsade de pointes, so the label says to avoid drugs that prolong the QT interval. 5 The label lists no contraindications. 5

The label rests on a randomized, open-label crossover trial against the insulin tolerance test (ITT) in 157 adults; 140 completed both tests. 5 Using a cut-off of 2.8 ng/mL, negative agreement with the ITT was 94% and positive agreement 74%. 5 The published trial reports 87% sensitivity, 96% specificity and 97% reproducibility on retesting. 1 One of 154 macimorelin tests failed for a technical reason, against 27 of 157 ITTs that failed to reach the required low blood sugar. 5

Keeping it good

How do I store Macimorelin?

Before mixing (powder)

Store in refrigerator at 2-8°C (36-46°F). Protect from light. Keep in original container until time of use.

After mixing (liquid)

Once reconstituted in water, solution must be used within 30 minutes. Do not refrigerate after reconstitution. Discard any unused portion.

Signs it has gone bad

Not our opinion — the published record

What the studies actually found about Macimorelin

2018

Macimorelin as a Diagnostic Test for Adult GH Deficiency

Macimorelin proved just as accurate as the dangerous insulin tolerance test for diagnosing growth hormone deficiency—catching real deficiencies 87% of the time and ruling out false positives 96% of the time. Plus, it's much safer and easier: just drink it instead of risking dangerous blood sugar drops from insulin shots.

Garcia JM, et al.

2023

Diagnosis and testing for growth hormone deficiency across the ages

Review of growth hormone deficiency testing in children and adults. Random GH levels are not recommended for screening. One or more stimulation tests (tests that push the body to release GH) may be needed. Peak GH cut-offs (the level that counts as normal) vary by age, test and assay (lab method).

Yuen KCJ, et al.

2026

MACRILEN (macimorelin) for oral solution — US Prescribing Information, revised 07/2026

Indicated for diagnosing adult GH deficiency (AGHD). Not established for BMI over 40 kg/m², and diagnostic accuracy was not shown in a 102-patient study of children. Contraindications (reasons not to use it): none. Single oral dose of 0.5 mg/kg after at least an 8-hour fast. GH is drawn at 30, 45, 60 and 90 minutes, and a peak below 2.8 ng/mL confirms AGHD. Warnings: QTc (a heart rhythm measure) rises about 11 msec, so avoid QT-prolonging drugs. Strong CYP3A4 inducers (drugs that speed up a liver enzyme) can cause false positives. Recent-onset hypothalamic disease (disease of the brain area that controls hormones) can give false negatives. Stop GH therapy at least one week before testing. Compared with the ITT (insulin tolerance test), it showed 94% negative and 74% positive agreement. Most common reactions: dysgeusia (an odd or bad taste) 4.5%, dizziness, headache and fatigue 3.9% each, nausea and hunger 3.2%.

Aeterna Zentaris / U.S. Food and Drug Administration

If this isn't the right fit

What people use instead of Macimorelin

Diagnosing Adult Growth Hormone Deficiency

  • Insulin Tolerance Test (ITT) — gold standard but invasive and requires blood glucose monitoring
  • GHRH + Arginine stimulation test — combines two stimuli but more complex
  • IGF-1 measurement — screening test, less specific than stimulation tests

Growth-hormone-boosting medicine (if approved)

  • Ibutamoren (MK-677) — ghrelin receptor agonist (investigational)
  • Tesamorelin — GHRH analog for HIV-associated lipodystrophy

Your questions

Macimorelin FAQ

What exactly is macimorelin used for?

Macimorelin (brand name Macrilen) is FDA-approved specifically for diagnosing adult growth hormone deficiency (AGHD) in patients suspected of having low GH. It's a single-dose diagnostic test, not a therapy. You take it once, and doctors measure your blood GH response to determine if your GH system is working normally.

How is macimorelin different from the insulin tolerance test (ITT)?

Both are FDA-approved tests for diagnosing GH deficiency, but macimorelin is safer and more convenient. ITT requires an insulin injection, blood sugar monitoring, and watching for low blood sugar symptoms. Macimorelin is simply drinking a reconstituted powder. Macimorelin has 87% sensitivity and 96% specificity, nearly identical accuracy to ITT, but with better tolerability and no serious adverse events in trials.

Do I have to fast before taking macimorelin?

Yes. You must fast for at least 8 hours before the test. 5 Food lowers absorption: a liquid meal cut peak levels by 55% and total exposure by 49%. 5 Your healthcare provider will give you specific fasting instructions.

What happens during the macimorelin test?

A healthcare professional dissolves the granules in water and you drink your weight-based dose (0.5 mg/kg) within 30 seconds, after fasting for at least 8 hours. 5 Blood is drawn for growth hormone at 30, 45, 60 and 90 minutes. 5 If the highest GH level stays below 2.8 ng/mL, the test is positive, which confirms adult GH deficiency; a higher peak is a negative result. 5

What are the common side effects?

Most side effects are mild and short-lived. The most common is dysgeusia (abnormal taste like metallic or bitter) affecting 4.5% of patients. Others include dizziness, headache, fatigue, nausea, and increased hunger — each occurring in 1-4% of patients. These usually resolve within 1-4 hours. No serious adverse events were reported in clinical trials.

Is macimorelin safe if I have heart problems?

Macimorelin causes a mild QT interval prolongation (approximately 11 msec increase). For most people this is not a concern, but if you have existing QT prolongation, take QT-prolonging medications, or have electrolyte abnormalities, you need careful evaluation. Your doctor will review this before the test and may recommend an ECG.

How accurate is macimorelin for diagnosing GH deficiency?

Clinical trials showed 87% sensitivity (correctly identifying people with deficiency) and 96% specificity (correctly identifying people without deficiency). Results are 97% reproducible on retesting. Macimorelin has 84% overall agreement with the insulin tolerance test, making it highly reliable for diagnostic purposes.

Can I use macimorelin if I'm already taking GH replacement therapy?

You need to stop GH therapy at least one week before the test. 5 GH products can blunt the GH response to macimorelin, which could make the test wrongly read as deficient. 5 Your doctor will advise you on when to stop and restart therapy.

What if my first test result is unclear or borderline?

If your GH level is borderline near the 2.8 ng/mL cutoff, your doctor may recommend retesting. With 97% reproducibility, a repeat test will give a consistent result. The test can be repeated as needed for diagnostic confirmation.

5 sources

References

Every numbered marker on this page points to one of these. Same sources, same numbering as the Macimorelin research profile on Peptide Initiative.

  1. Macimorelin as a Diagnostic Test for Adult GH DeficiencyGarcia JM, et al. · 2018
  2. Molecular recognition of two approved drugs Macimorelin and Anamorelin by the growth hormone secretagogue receptorWang RL, et al. · 2025
  3. Diagnosis and testing for growth hormone deficiency across the agesYuen KCJ, et al. · 2023
  4. MACRILEN (macimorelin) for oral solution — FDA Prescribing InformationAeterna Zentaris · 2017
  5. MACRILEN (macimorelin) for oral solution — US Prescribing Information, revised 07/2026Aeterna Zentaris / U.S. Food and Drug Administration · 2026

Want the deep science?

Read the full Macimorelin research profile

Every claim on this page traces back to the research database behind Peptide Initiative — studies, citations, clinical trial data, and the technical detail we deliberately left out here.

Open the research profile

More growth hormone guides

This guide is education, not medical advice. Talk to a clinician before taking anything.