Anamorelin

[Megadick3000]

anyone experimented with this?

Anyone know the dosage range?

I just stumbled across this. It's like ibutamoren mesylate (mk-677) in that it's an orally active Ghrelin receptor ligand. It's currently in phase 3 clinical trials, unlike mk-677 which was abandoned for reasons I don't know. It looks like it will be making it to market, which makes me wonder why there's so little information on it in relation to BBing or anti aging.

Anyone?

 

[tenpoundsleft]

anyone experimented with this?

Anyone know the dosage range?

I just stumbled across this. It's like ibutamoren mesylate (mk-677) in that it's an orally active Ghrelin receptor ligand. It's currently in phase 3 clinical trials, unlike mk-677 which was abandoned for reasons I don't know. It looks like it will be making it to market, which makes me wonder why there's so little information on it in relation to BBing or anti aging.

Anyone?

Here's a link with info, looks quite interesting

Anamorelin - Wikipedia, the free encyclopedia

 

[Megadick3000]

Here's a link with info, looks quite interesting

Anamorelin - Wikipedia, the free encyclopedia

Of course I already wiki'd it, this ain't my first rodeo!

I found at least one peptide retailer claiming to offer it also. Curious if anyone ever tried it and what dosage if they did. Its interesting that it's even cleared phase 3 clinical trials, looks for certain it will make it to market as an RX soon.

 

[Roco Bama]

will probably be a lot more expensive than mk

 

[Megadick3000]

will probably be a lot more expensive than mk

Not sure. The sources site I'm looking at sells a bottle for $80 but it bothers me that they don't list what the mg/ml concentration is, or if it's even in solution, nor even the quantity your actually getting for the price. Sketchy, to say the least.

 

[tenpoundsleft]

Of course I already wiki'd it, this ain't my first rodeo!

I found at least one peptide retailer claiming to offer it also. Curious if anyone ever tried it and what dosage if they did. Its interesting that it's even cleared phase 3 clinical trials, looks for certain it will make it to market as an RX soon.

Obviously you'd done searches - I added the link to give other readers a quick way to find some info, you hadn't provided that much.

I've tried various peptides, will be cool to see if the claims for this one stands up to reality.

 

[Roco Bama]

Not sure. The sources site I'm looking at sells a bottle for $80 but it bothers me that they don't list what the mg/ml concentration is, or if it's even in solution, nor even the quantity your actually getting for the price. Sketchy, to say the least.

it takes a while for research companies to put it in stock. after a month or 2, the powder will be available in china. I think anamorelin causes less bloat than mk. u can contact the company n ask them about the amount or concentration of anamorelin.

 

[Megadick3000]

it takes a while for research companies to put it in stock. after a month or 2, the powder will be available in china. I think anamorelin causes less bloat than mk. u can contact the company n ask them about the amount or concentration of anamorelin.

It's available as raw ApI already. I contacted one of my Chinese factories I've done biz with and they are offering it, but at literally 10x the price per gram verse ibutamoren mesylate (mk-677)... Which is pretty damn excessive since I think it requires a larger dose than ibutamoren too.

 

[Michael Scally MD]

Anamorelin will never be FDA Approved. An improvement in LBM is NOT acceptable for approval. There will need to be a significant OS. Further, there will need to be some "real" PRO for even the slightest chance of approval. It will likely be the same for the EMA.

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. The Lancet Oncology 2016;17(4):519-31. http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00558-6/abstract

Background - Patients with advanced cancer frequently experience anorexia and cachexia, which are associated with reduced food intake, altered body composition, and decreased functionality. We assessed anamorelin, a novel ghrelin-receptor agonist, on cachexia in patients with advanced non-small-cell lung cancer and cachexia.

Methods - ROMANA 1 and ROMANA 2 were randomised, double-blind, placebo-controlled phase 3 trials done at 93 sites in 19 countries. Patients with inoperable stage III or IV non-small-cell lung cancer and cachexia (defined as ≥5% weight loss within 6 months or body-mass index <20 kg/m2) were randomly assigned 2:1 to anamorelin 100 mg orally once daily or placebo, with a computer-generated randomisation algorithm stratified by geographical region, cancer treatment status, and weight loss over the previous 6 months. Co-primary efficacy endpoints were the median change in lean body mass and handgrip strength over 12 weeks and were measured in all study participants (intention-to-treat population). Both trials are now completed and are registered with ClinicalTrials.gov, numbers NCT01387269 and NCT01387282.

Findings - From July 8, 2011, to Jan 28, 2014, 484 patients were enrolled in ROMANA 1 (323 to anamorelin, 161 to placebo), and from July 14, 2011, to Oct 31, 2013, 495 patients were enrolled in ROMANA 2 (330 to anamorelin, 165 to placebo). Over 12 weeks, lean body mass increased in patients assigned to anamorelin compared with those assigned to placebo in ROMANA 1 (median increase 0·99 kg [95% CI 0·61 to 1·36] vs −0·47 kg [–1·00 to 0·21], p<0·0001) and ROMANA 2 (0·65 kg [0·38 to 0·91] vs −0·98 kg [–1·49 to −0·41], p<0·0001). We noted no difference in handgrip strength in ROMANA 1 (−1·10 kg [–1·69 to −0·40] vs −1·58 kg [–2·99 to −1·14], p=0·15) or ROMANA 2 (−1·49 kg [–2·06 to −0·58] vs −0·95 kg [–1·56 to 0·04], p=0·65). There were no differences in grade 3–4 treatment-related adverse events between study groups; the most common grade 3–4 adverse event was hyperglycaemia, occurring in one (<1%) of 320 patients given anamorelin in ROMANA 1 and in four (1%) of 330 patients given anamorelin in ROMANA 2.

Interpretation - Anamorelin significantly increased lean body mass, but not handgrip, strength in patients with advanced non-small-cell lung cancer. Considering the unmet medical need for safe and effective treatments for cachexia, anamorelin might be a treatment option for patients with cancer anorexia and cachexia.

Funding - Helsinn Therapeutics. Cancer Supportive Care Company | Helsinn | Helsinn Corporate / HELSINN ANNOUNCES EUROPEAN MEDICINES AGENCY ACCEPTANCE OF MARKETING AUTHORIZATION APPLICATION FOR ANAMORELIN HCL | Helsinn Corporate

Clinical Trials - https://clinicaltrials.gov/ct2/results?term=Anamorelin+&Search=Search

 

[ecdysone]

I see Transformix Peptides is offering a 100 mg/ml 60ml bottle for $100 which seems quite reasonable considering the normal dose is around 100 mg/day. Don't know anything about them though.

Funny the stuff is called anaMORELIN not anaMOREN since it's not a peptide.

 

[Roco Bama]

I'll give it a try if anamorelin doesn't cause subcutaneous water retention. The main reason I hate about Mk is water retention. It destroys muscle definition

 

[Dr JIM]

Anamorelin will never be FDA Approved. An improvement in LBM is NOT acceptable for approval. There will need to be a significant OS. Further, there will need to be some "real" PRO for even the slightest chance of approval. It will likely be the same for the EMA.

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. The Lancet Oncology 2016;17(4):519-31. http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00558-6/abstract

Background - Patients with advanced cancer frequently experience anorexia and cachexia, which are associated with reduced food intake, altered body composition, and decreased functionality. We assessed anamorelin, a novel ghrelin-receptor agonist, on cachexia in patients with advanced non-small-cell lung cancer and cachexia.

Methods - ROMANA 1 and ROMANA 2 were randomised, double-blind, placebo-controlled phase 3 trials done at 93 sites in 19 countries. Patients with inoperable stage III or IV non-small-cell lung cancer and cachexia (defined as ≥5% weight loss within 6 months or body-mass index <20 kg/m2) were randomly assigned 2:1 to anamorelin 100 mg orally once daily or placebo, with a computer-generated randomisation algorithm stratified by geographical region, cancer treatment status, and weight loss over the previous 6 months. Co-primary efficacy endpoints were the median change in lean body mass and handgrip strength over 12 weeks and were measured in all study participants (intention-to-treat population). Both trials are now completed and are registered with ClinicalTrials.gov, numbers NCT01387269 and NCT01387282.

Findings - From July 8, 2011, to Jan 28, 2014, 484 patients were enrolled in ROMANA 1 (323 to anamorelin, 161 to placebo), and from July 14, 2011, to Oct 31, 2013, 495 patients were enrolled in ROMANA 2 (330 to anamorelin, 165 to placebo). Over 12 weeks, lean body mass increased in patients assigned to anamorelin compared with those assigned to placebo in ROMANA 1 (median increase 0·99 kg [95% CI 0·61 to 1·36] vs −0·47 kg [–1·00 to 0·21], p<0·0001) and ROMANA 2 (0·65 kg [0·38 to 0·91] vs −0·98 kg [–1·49 to −0·41], p<0·0001). We noted no difference in handgrip strength in ROMANA 1 (−1·10 kg [–1·69 to −0·40] vs −1·58 kg [–2·99 to −1·14], p=0·15) or ROMANA 2 (−1·49 kg [–2·06 to −0·58] vs −0·95 kg [–1·56 to 0·04], p=0·65). There were no differences in grade 3–4 treatment-related adverse events between study groups; the most common grade 3–4 adverse event was hyperglycaemia, occurring in one (<1%) of 320 patients given anamorelin in ROMANA 1 and in four (1%) of 330 patients given anamorelin in ROMANA 2.

Interpretation - Anamorelin significantly increased lean body mass, but not handgrip, strength in patients with advanced non-small-cell lung cancer. Considering the unmet medical need for safe and effective treatments for cachexia, anamorelin might be a treatment option for patients with cancer anorexia and cachexia.

Funding - Helsinn Therapeutics. Cancer Supportive Care Company | Helsinn | Helsinn Corporate / HELSINN ANNOUNCES EUROPEAN MEDICINES AGENCY ACCEPTANCE OF MARKETING AUTHORIZATION APPLICATION FOR ANAMORELIN HCL | Helsinn Corporate

Clinical Trials - https://clinicaltrials.gov/ct2/results?term=Anamorelin+&Search=Search

Agreed Doc S like many drugs that "show promise" during initial testing it all comes out in the wash once such substances are compared to current available therapies with KNOWN risk/benefit profiles.

Part of the problem with this substance and likely others like it is the "improvement in LBM" is often the result of excessive FLUID RETENTION, and it seems a couple Meso mates have already experienced that particular ADVERSE EFFECT.

 

[Megadick3000]

Yup I definitely get fluid retention from GH modulating agents. I swell up all over, even my fingers becom noticeably fuller. Gotta be interstitial fluid buildup, which is a side effect in acromegaly.

If the company has no hopes of getting it to market, why ar they jumping through the presumably very expensive hoops necessary to get as far as they have with it??

Is cancer related cachexia not a valid medical reason for approval?

If not, then how come anabolic steroids like oxandrolne are approved for prescription when they are prescribed for things like AIDS related muscle wasting??

 

[Michael Scally MD]

Crawford J. Cancer cachexia: Are we ready to take a step forward? Cancer. http://dx.doi.org/10.1002/cncr.31126

The field of cancer cachexia at both the preclinical and clinical levels will benefit from the further investigation and refinement of its mechanisms and further study of potential agents to define the best treatment outcomes for patients. In the meantime, the availability of anamorelin, a promising agent in the clinic would be extremely valuable to move that research forward.


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. http://dx.doi.org/10.1002/cncr.31128

BACKGROUND: Cachexia, described as weight loss (mainly in lean body mass [LBM]) and anorexia, is common in patients with advanced cancer. This study examined the efficacy and safety of anamorelin (ONO-7643), a novel selective ghrelin receptor agonist, in Japanese cancer patients with cachexia.

METHODS: This double-blind clinical trial (ONO-7643-04) enrolled 174 patients with unresectable stage III/IV non–small cell lung cancer (NSCLC) and cachexia in Japan. Patients were randomized to daily oral anamorelin (100 mg) or a placebo for 12 weeks. The primary endpoint was the change from the baseline LBM (measured with dual-energy x-ray absorptiometry) over 12 weeks. The secondary endpoints were changes in appetite, body weight, quality of life, handgrip strength (HGS), and 6-minute walk test (6MWT) results.

RESULTS: The least squares mean change (plus or minus the standard error) in LBM from the baseline over 12 weeks was 1.38 ± 0.18 and −0.17 ± 0.17 kg in the anamorelin and placebo groups, respectively (P < .0001). Changes from the baseline in LBM, body weight, and anorexia symptoms showed significant differences between the 2 treatment groups at all time points. Anamorelin increased prealbumin at weeks 3 and 9. No changes in HGS or 6MWT were detected between the groups. Twelve weeks' treatment with anamorelin was safe and well tolerated in NSCLC patients.

CONCLUSIONS: Anamorelin significantly increased LBM and improved anorexia symptoms and the nutritional state, but not motor function, in Japanese patients with advanced NSCLC. Because no effective treatment for cancer cachexia is currently available, anamorelin can be a beneficial treatment option.

 

[Michael Scally MD]

Ramage MI, Skipworth RJE. The relationship between muscle mass and function in cancer cachexia: smoke and mirrors? Current Opinion in Supportive and Palliative Care. The relationship between muscle mass and function in cancer ... : Current Opinion in Supportive and Palliative Care

Purpose of review Randomized clinical trials of cancer cachexia interventions are based on the premise that an increase in the muscle mass of patients is associated with consequent improvements in muscle function, and ultimately, quality of life. However, recent trials that have succeeded in demonstrating increases in lean body mass have been unable to show associated increases in patient physical function.

In this review, we examine the potential causes for this lack of association between muscle mass and function in cancer cachexia, paying particular attention to those factors that may be at play when using body composition analysis techniques involving cross-sectional imaging. Moreover, we propose a new population-specific model for the relationship between muscle mass and physical function in patients with cancer cachexia.

Recent findings The ROMANA 1 and 2 trials of anamorelin (a novel ghrelin agonist) and the POWER 1 and 2 trials of enobosarm (a selective androgen receptor modulator) were able to demonstrate improvements in patient lean body mass, but not the functional co-primary endpoints of handgrip strength and stair climb power, respectively. We report similar confirmatory findings in other studies, and describe potential reasons for these observations.

Summary The relationship between muscle mass and muscle function is complex and unlikely to be linear. Furthermore, the relationship is influenced by the techniques used to assess nutritional endpoints [e.g. computed tomography (CT)]; the nature of the chosen physical function outcome measures; and the sex and severity of the recruited cachectic patients. Such factors need to be considered when designing intervention trials for cancer cachexia with functional endpoints.

 

[master.on]

At the end you'd need bloodwork to prove that
1 Anamorelin significantly increases GH
2 What you have at hand is legit Anamorelin.