MEDICAL DISCLAIMER: Educational research guidelines only. Lyophilized peptides are investigational chemical compounds and are NOT approved for human consumption, diagnosis, or therapy. Consult a licensed physician before any research application.
Anamorelin Dosage Chart, Schedule & Reconstitution Protocol
Quickstart Highlights
Anamorelin (ONO-7643, RC-1291; brand Adlumiz/Edlumiz) is a small-molecule, orally active ghrelin/GHS-R1a agonist for cancer cachexia. It mimics ghrelin to stimulate appetite and raise GH, IGF-1 and IGFBP-3, increasing lean body mass and body weight (PMID 27005463, PMID 26906526). The standard dose is 100 mg once daily on an empty stomach, reassessed at 3 weeks and typically given for about 12 weeks. In the ROMANA 1 and 2 phase 3 trials anamorelin significantly increased lean body mass and improved anorexia-cachexia symptoms but did NOT improve handgrip strength, and quality-of-life and survival benefits were not established. It is approved only in Japan; the EMA refused authorisation in 2017 and it is not FDA-approved. It is a tablet, not an injectable — the subcutaneous reconstitution figures here are an educational measurement reference only and not medical advice.
Reconstitute: Add 1 mL bacteriostatic water → 50 mg/mL concentration.
Typical dose: 100 mg once daily orally
Easy measuring: At 50 mg/mL, 1 unit = 0.01 mL = 0.5 mg (500 mcg) on a U-100 insulin syringe.
Storage: Lyophilized research powder stored frozen at −20 °C; reconstituted solution refrigerated at 2-8 °C and used within about 4 weeks. The approved commercial product is a 50 mg oral tablet stored at room temperature, protected from light and moisture.
Half-life: Terminal ~6-7 h after rapid biphasic absorption (peaks ~30-45 min and 2-4 h); supports once-daily dosing. Exposure ~1.8-1.9x higher in women.
Route: Oral 50 mg tablets, 100 mg once daily on an empty stomach; modeled here as a subcutaneous reconstitution reference for measurement only.
Status: Approved in Japan for cancer cachexia (NSCLC, gastric, pancreatic, colorectal); EMA refused authorisation in 2017; not FDA-approved. Educational content, not medical advice.
About Anamorelin
Anamorelin (ONO-7643, RC-1291; marketed in Japan as Adlumiz/Edlumiz) is a small-molecule, orally active ghrelin-receptor (GHS-R1a) agonist used to treat cancer cachexia. By mimicking the hormone ghrelin at the pituitary and hypothalamus, it stimulates appetite and drives a rise in growth hormone, IGF-1 and IGFBP-3 that increases lean body mass and body weight [1][5]. Clinically, and in every published human trial, anamorelin is swallowed as a tablet — 100 mg once daily on an empty stomach — so it is not reconstituted or injected in real-world use. The subcutaneous vial-and-water figures below are an educational reconstitution reference that mirrors how this site models all oral compounds; they are not a clinically validated delivery method.\n\nThis guide models a 50 mg vial (matching the real 50 mg tablet SKU) reconstituted with 1.0 mL of bacteriostatic water to give 50 mg/mL, or 500 mcg per insulin-syringe unit. On that scale a 50 mg amount maps to 100 units (one full U-100 syringe) and the approved 100 mg once-daily dose maps to roughly 200 units — which exceeds a single syringe and would be split across two injections. That awkward, high-volume math is exactly why anamorelin is dosed as an oral tablet rather than by injection.\n\nFrequency: Once daily on an empty stomach. If no benefit is seen by three weeks, treatment is stopped; most controlled studies ran for about 12 weeks [3][9]. Anamorelin is approved only in Japan; the EMA refused marketing authorisation in 2017 and it is not FDA-approved, so outside Japan it is research/educational only [7][8].
Quick Protocol Navigation
Reconstitution Instruction & Mixing Step-by-Step
Lyophilized powder must be reconstituted carefully. Agitating peptide chains can shear disulfide bonds and render the peptide biologically inert.
Draw 1.0 mL of bacteriostatic water into a sterile syringe.
Inject the water slowly down the inner glass wall of the 50 mg anamorelin vial; do not aim the stream at the powder and do not shake.
Swirl or roll the vial gently until the solution is completely clear; the result is 50 mg/mL, or 500 mcg per insulin-syringe unit.
Store refrigerated at 2-8 °C and draw the prescribed units per dose: 50 mg ≈ 100 units (1.0 mL), and the approved 100 mg dose ≈ 200 units, which exceeds one syringe and is split across two injections.
Educational note: anamorelin is clinically taken ORALLY as a 50 mg tablet once daily on an empty stomach — these subcutaneous reconstitution figures are a measurement reference only and are not how the drug is actually administered.
Interactive Anamorelin Syringe Calculator
Currently visualizing the 50 mg vial reconstituted with 1 mL bacteriostatic water. Adjust the target dose to dynamically render syringe units.
Reconstitution Calculation: 50mg dry powder in 1mL water yields 50.00 mg/mL. To evaluate a 250mcg dose, pull to 0.5 units (1 syringe ticks).
U-100 Syringe Representation
Educational reference visual. Assumes standard U-100 insulin syringe where 1.0 mL volume = 100 units.
Titration & Dose Escalation Schedules
| Phase | Dose per injection | Units (per injection) |
|---|---|---|
| Educational starter reference — 50 mg (one 50 mg tablet equivalent; ≈100 units / 1.0 mL, one full syringe) | 50000 mcg (50 mg) | 100 units (1.00 mL) |
| Approved clinical dose — 100 mg once daily on an empty stomach (≈200 units; split across two injections in this SC model) | 100000 mcg (100 mg) | 200 units (2.00 mL) |
| Week 3 reassessment — continue 100 mg once daily if appetite/weight improve, otherwise discontinue; most trials capped at ~12 weeks | 100000 mcg (100 mg) | 200 units (2.00 mL) |
Administration guidelines: Refer to guidelines | 1 mL Reconstitution
Research Supplies Quantity Planner
Scientific mathematical planning of syringes, bacteriostatic water and dry vials needed for extended research blocks using the 50 mg vial.
Peptide Vials (Anamorelin, 50 mg each):
- check8 weeks at 100 mg/day ≈ 112 vials (5,600 mg total)
- check12 weeks at 100 mg/day ≈ 168 vials (8,400 mg total) — matches the ~12-week studied course
- check16 weeks at 100 mg/day ≈ 224 vials (11,200 mg total) — the very high count illustrates why anamorelin is dosed as an oral tablet
Insulin Syringes (U-100):
- check100 mg ≈ 200 units, which exceeds one 1 mL syringe and is split into two injections per day (14 per week)
- check8 weeks ≈ 112 syringes; 12 weeks ≈ 168 syringes
- check16 weeks ≈ 224 syringes — in reality the drug is swallowed, so no syringes are needed
Bacteriostatic Water (30 mL bottles): Use 1 mL per 50 mg vial for reconstitution.
- check8 weeks ≈ 112 mL ≈ 4 bottles
- check12 weeks ≈ 168 mL ≈ 6 bottles
- check16 weeks ≈ 224 mL ≈ 8 bottles
Alcohol Swabs:
- check1-2 swabs per injection (vial top + injection site), two injections per day
- check8 weeks ≈ 220-450 swabs; 12 weeks ≈ 340-670 swabs
- check16 weeks ≈ 450-900 swabs; keep extras for re-swabbing multi-use vials
Mechanism of Action (MOA)
Anamorelin is a synthetic, non-peptide small molecule (CAS 249921-19-5; hydrochloride 861998-00-7) engineered to mimic the endogenous hormone ghrelin while remaining orally active and metabolically stable. It is a selective agonist of the growth hormone secretagogue receptor type 1a (GHS-R1a), the same receptor ghrelin activates. By binding GHS-R1a on hypothalamic appetite circuits and on pituitary somatotrophs, anamorelin produces two coupled effects: it stimulates appetite and food intake, and it amplifies pulsatile growth hormone (GH) secretion, which raises hepatic IGF-1 and IGF-binding protein 3 [1][5]. This neuroendocrine and orexigenic action is the rationale for using it in cancer cachexia, a wasting syndrome of involuntary weight loss, muscle depletion and anorexia that worsens prognosis and is poorly addressed by nutrition alone.\n\nUnlike injectable ghrelin analogues, anamorelin is a tablet. In a dedicated pharmacokinetic study, a single oral dose was rapidly absorbed, with peak plasma concentrations appearing in two phases — roughly 30-45 minutes and again 2-4 hours after dosing — and then declining biexponentially with a mean terminal half-life of about 6-7 hours [5]. That half-life, combined with sustained downstream GH/IGF-1 signaling, supports once-daily dosing. Exposure (AUC) was meaningfully higher in women than men, while age had little effect on Cmax or AUC; the GH response was attenuated in elderly subjects [5]. Anamorelin is taken on an empty stomach because food impairs its absorption, and it is cleared largely by hepatic metabolism, with CYP3A4 a major contributing pathway, so strong CYP3A4 inhibitors or inducers can shift exposure.\n\nThe approved adult regimen is 100 mg once daily, with a built-in stopping rule: if no benefit is seen by three weeks, treatment is discontinued [9]. Across the clinical program, anamorelin reliably increased lean body mass, body weight and appetite/anorexia-cachexia symptom scores. In the Japanese registration NSCLC trial the least-squares mean change in lean body mass over 12 weeks was +1.38 kg with anamorelin versus −0.17 kg with placebo [3]. Crucially, however, the large ROMANA 1 and ROMANA 2 phase 3 trials showed that the lean-mass gains did not translate into improved handgrip strength, a co-primary functional endpoint, and quality-of-life and survival benefits were not established [2].\n\nThat efficacy gap shaped its regulatory fate. Anamorelin was approved in Japan (Ono Pharmaceutical, licensed from Helsinn) for cachexia in non-small cell lung, gastric, pancreatic and colorectal cancers, becoming the first ghrelin-receptor agonist approved for cancer cachexia [7][9]. In Europe, the EMA's CHMP judged the lean-mass effect marginal, found no proven effect on grip strength or quality of life, and cited inadequate safety data, refusing marketing authorisation in 2017 [8]. It is not approved by the US FDA. The real route is oral; the subcutaneous reconstitution scheme on this page is an educational measurement convention, not a clinical method.
Clinical Trial Efficacy Highlights
- starTakayama and colleagues (2016, Supportive Care in Cancer) ran a randomized, double-blind, placebo-controlled phase 2 trial of anamorelin 100 mg once daily in 181 Japanese patients with NSCLC and cachexia; anamorelin significantly increased lean body mass and body weight over 12 weeks and improved appetite and quality-of-life measures relative to placebo [1].
- starKatakami and colleagues (2018, Cancer; the ONO-7643-04 registration trial) randomized 174 Japanese NSCLC-cachexia patients to anamorelin 100 mg/day or placebo; the least-squares mean change in lean body mass over 12 weeks was +1.38 kg with anamorelin versus −0.17 kg with placebo, with significant improvements in anorexia symptoms and nutritional markers but no improvement in handgrip strength [3].
- starTemel and colleagues (2016, The Lancet Oncology) reported the pivotal ROMANA 1 and ROMANA 2 phase 3 trials in roughly 980 patients with advanced NSCLC and cachexia; anamorelin significantly increased lean body mass and improved anorexia-cachexia symptoms over 12 weeks, but did NOT improve handgrip strength, one of the two co-primary endpoints [2].
- starCurrow and colleagues (2017, Annals of Oncology) conducted ROMANA 3, a 12-week double-blind safety extension; treatment-emergent adverse-event rates were comparable between anamorelin and placebo (52.2% vs 55.7%) with similar serious-event rates (12.8% vs 12.6%) and no drug-related deaths, and the body-weight and symptom benefits achieved in ROMANA 1/2 were sustained through 24 weeks [6].
- starHamauchi and colleagues (2019, Cancer) studied anamorelin 100 mg/day in 50 Japanese patients with advanced gastric, pancreatic or colorectal cancer and cachexia; mean lean body mass rose about 1.89 kg and body weight about 1.41 kg by week 12, with increases in IGF-1, IGFBP-3 and transthyretin, supporting use across multiple cancer types [4].
- starLeese and colleagues (2015, Clinical Pharmacology in Drug Development) characterized anamorelin pharmacokinetics in healthy volunteers after a single 25 mg oral dose: rapid biphasic absorption (peaks at 30-45 minutes and 2-4 hours), a mean terminal half-life of 6-7 hours, a rapid GH rise, and roughly 1.8-1.9-fold higher exposure in women than men with little age effect on Cmax/AUC [5].
- starOn the strength of the Japanese phase 2 NSCLC data and an open-label gastrointestinal-cancer study, anamorelin became the first ghrelin-receptor agonist approved for cancer cachexia, granted manufacturing and marketing approval in Japan for NSCLC, gastric, pancreatic and colorectal cancer cachexia [7][9].
- starIn contrast, the EMA's CHMP concluded the effect on lean body mass was marginal with no proven benefit on handgrip strength or quality of life and inadequate safety data, and refused EU marketing authorisation in 2017 — a divergence that frames anamorelin's evidence base as positive for body composition but unproven for physical function and survival [8].
Side Effects & Tolerability Profile
Clinical subjects transiently report mild side effects. Slowly escalating the titration dose represents the single most effective intervention to limit side effects.
- warningHyperglycemia and new or worsening diabetes are among the most clinically important effects, reflecting the GH/IGF-1 axis activation; fasting glucose should be monitored and caution is needed in patients with diabetes, prediabetes or metabolic syndrome [4][9].
- warningCardiac conduction effects, including QT-interval prolongation and other ECG changes, have been reported; baseline and on-treatment ECG monitoring is advised, and anamorelin is generally avoided with other QT-prolonging drugs or significant cardiac disease [9].
- warningHepatic effects such as elevated liver enzymes and hepatic dysfunction occurred in trials (for example, raised transaminases in the gastrointestinal-cancer study); liver function should be monitored [4].
- warningGastrointestinal effects including nausea and changes in appetite-related symptoms can occur, though overall tolerability was broadly comparable to placebo in the ROMANA 3 safety extension [6].
- warningBecause it is taken on an empty stomach and partly metabolized via CYP3A4, food impairs absorption and strong CYP3A4 inhibitors or inducers can alter exposure; co-medication should be reviewed in cancer patients on complex regimens.
- warningEfficacy is limited to body composition and symptoms: anamorelin did not improve handgrip strength in the pivotal phase 3 trials, and effects on physical function, quality of life and survival are not established, so it should not be presented as a strength- or longevity-enhancing agent [2][8].
- warningAnamorelin is intended for adults with cancer cachexia under specialist supervision; it is not a bodybuilding, fitness or anti-aging compound, and the approved stopping rule (discontinue if no benefit by 3 weeks) reflects how its risk-benefit was framed by regulators [9].
- warningRegulatory/research status: anamorelin is approved ONLY in Japan; the EMA refused EU marketing authorisation in 2017 and it is not FDA-approved, so outside Japan it is investigational/educational only and long-term safety beyond ~24 weeks is not well characterized [7][8].
Subcutaneous Injection Technique
Most research peptides require subcutaneous injection into fatty tissue. Never inject directly into a blood vessel or deep muscle tissue unless clinically detailed.
1. Site Selection
Common locations include the abdomen (2 inches from navel), outer upper arms, or thighs.
2. Sanitization
Thoroughly clean the selected site, stopper and vial top using 70% isopropyl alcohol prep swabs.
3. Angle & Push
Pinch the skin and insert the needle at a 45 to 90-degree angle. Depress plunger smoothly.
4. Site Rotation
Rotate injection sites continuously to avoid lipodystrophy or tissue scarring.
Frequently Asked Questions
What is the typical Anamorelin dosage?expand_more
The established Anamorelin dosage is 100 mg orally once daily, taken on an empty stomach. This is the dose approved in Japan and used in the ROMANA phase 3 program and the Japanese registration trials. Treatment is reassessed at three weeks — if there is no benefit, it is discontinued — and most studies limited exposure to about 12 weeks. Because the real product is a 50 mg tablet (two tablets per day), the subcutaneous vial-and-water figures on this page are an educational reconstitution reference only, not the clinical route.
Is Anamorelin FDA approved?expand_more
No. Anamorelin is not approved by the US FDA for any indication. It is approved only in Japan, where Ono Pharmaceutical received manufacturing and marketing approval (brand Adlumiz/Edlumiz) for cachexia in non-small cell lung, gastric, pancreatic and colorectal cancers. In Europe, the EMA's CHMP adopted a negative opinion and refused marketing authorisation in 2017, citing a marginal effect on lean body mass, no proven benefit on handgrip strength or quality of life, and inadequate safety data. Outside Japan it should be regarded as investigational/educational only.
What is the half-life of Anamorelin?expand_more
After a single oral dose, anamorelin is absorbed rapidly in a biphasic pattern, with peak plasma concentrations around 30-45 minutes and again 2-4 hours after dosing, then declining biexponentially with a mean terminal half-life of about 6-7 hours. That half-life, combined with longer downstream GH and IGF-1 signaling, supports once-daily dosing. Exposure is roughly 1.8-1.9-fold higher in women than men, while age has little effect on peak concentration or total exposure. It is taken on an empty stomach because food reduces absorption, and it is cleared mainly by hepatic metabolism (CYP3A4 contributes).
How is Anamorelin reconstituted and administered?expand_more
In real-world use anamorelin is not reconstituted or injected — it is swallowed as a 50 mg oral tablet, 100 mg (two tablets) once daily on an empty stomach. For the educational subcutaneous model on this site, a 50 mg vial is mixed with 1.0 mL of bacteriostatic water to give 50 mg/mL (500 mcg per insulin-syringe unit): draw the water slowly down the vial wall, swirl gently until clear, and refrigerate. On that scale 50 mg is about 100 units (one full U-100 syringe) and the 100 mg dose is about 200 units, which exceeds one syringe and would be split — a clear sign that oral tablets, not injections, are the practical route.
Can Anamorelin be stacked with other compounds?expand_more
Anamorelin is a prescription oncology supportive-care drug studied as monotherapy alongside standard cancer care and nutrition; it has not been validated in combination with bodybuilding or anti-aging stacks, and doing so is not supported by safety data. Combining it with other GH secretagogues or insulin-affecting agents could worsen its known risks of hyperglycemia and glucose intolerance, and combining it with QT-prolonging medications could increase cardiac risk given its reported ECG effects. Because CYP3A4 contributes to its metabolism, strong CYP3A4 inhibitors or inducers can change exposure. Any combination should be considered experimental and is not medical advice.
Related Guides & Tools
Step-by-step references for reconstituting, measuring, and storing Anamorelin, plus the universal dosing calculator.
Academic References & Study Citations
Takayama K, Katakami N, Yokoyama T, et al. Anamorelin (ONO-7643) in Japanese patients with non-small cell lung cancer and cachexia: results of a randomized phase 2 trial. Support Care Cancer. 2016;24(8):3495-3505. View Scientific Paper →
Temel JS, Abernethy AP, Currow DC, et al. Anamorelin in patients with non-small-cell lung cancer and cachexia (ROMANA 1 and ROMANA 2): results from two randomised, double-blind, phase 3 trials. Lancet Oncol. 2016;17(4):519-531. View Scientific Paper →
Katakami N, Uchino J, Yokoyama T, et al. Anamorelin (ONO-7643) for the treatment of patients with non-small cell lung cancer and cachexia: results from a randomized, double-blind, placebo-controlled, multicenter study of Japanese patients (ONO-7643-04). Cancer. 2018;124(3):606-616. View Scientific Paper →
Hamauchi S, Furuse J, Takano T, et al. A multicenter, open-label, single-arm study of anamorelin (ONO-7643) in advanced gastrointestinal cancer patients with cancer cachexia. Cancer. 2019;125(23):4294-4302. View Scientific Paper →
Leese PT, Trang JM, Blum RA, de Groot E. An open-label clinical trial of the effects of age and gender on the pharmacodynamics, pharmacokinetics and safety of the ghrelin receptor agonist anamorelin. Clin Pharmacol Drug Dev. 2015;4(6):419-424. View Scientific Paper →
Currow D, Temel JS, Abernethy A, Milanowski J, Friend J, Fearon KC. ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia. Ann Oncol. 2017;28(8):1949-1956. View Scientific Paper →
Ono Pharmaceutical Co., Ltd. ONO Receives a Manufacturing and Marketing Approval of Adlumiz (Anamorelin), a Ghrelin Receptor Agonist for the Treatment of Cancer Cachexia in Japan. Press release, January 22, 2021. View Scientific Paper →
European Medicines Agency. Adlumiz (anamorelin hydrochloride): refusal of marketing authorisation (CHMP negative opinion, 2017). EPAR summary. View Scientific Paper →
Currow DC, Maddocks M, Cella D, Muscaritoli M. The regulatory approval of anamorelin for treatment of cachexia in patients with non-small cell lung cancer, gastric cancer, pancreatic cancer, and colorectal cancer in Japan: facts and numbers. J Cachexia Sarcopenia Muscle. 2021;12(2):538-542. View Scientific Paper →