Review
This paper critically examines the regulatory approval of two FDA-approved drugs for hypoactive sexual desire disorder (HSDD) in women: flibanserin (Addyi, approved 2015) and bremelanotide (Vyleesi, approved 2019). The authors analyze the clinical trial data and outcome measures underpinning each approval. They report that clinical trials for flibanserin showed an average of only approximately one additional enjoyable sexual experience every two months compared to placebo, while bremelanotide trials showed no such numerical gain. The paper also highlights concerns about shifts in primary outcome measures during trials, a contested diagnostic indication, and the influence of a politicized, industry-sponsored patient advocacy campaign on flibanserin's approval—which succeeded on its third regulatory attempt. The authors argue that bremelanotide's approval, despite even weaker efficacy evidence, was facilitated by the regulatory precedent set by flibanserin. The paper calls for reconsideration of these approvals and recommends reforms to better manage conflicts of interest and define clinically meaningful benefit in future regulatory decisions. A key limitation is that this is an opinion/review piece rather than an original clinical study, and does not present new primary data.
Drug and therapeutics bulletin · Oct 2021DOI ↗ 🧪 TrialInsufficient
Registered Phase 2 interventional trial (active not recruiting). The prevalence of adolescent severe obesity is at an all-time high in the United States and the refractory nature of this disease has led to a serious and challenging conundrum in terms of how to provide effective, safe, scalable, and durable treatments without placing undue strain on the healthcare system. Clinical practice guidelines recommend behavioral interventions as the primary strategy for all ages and classes of obesity - moderate to severe. In 2017, the U.S. Preventive Services Task Force (USPSTF) released updated scree
ClinicalTrials.gov · May 2021View trial ↗ 🧪 TrialInsufficient
Registered Phase 3 interventional trial (active not recruiting). Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance. Participants will need to inject themselves with medicine under the skin. Participants will need to do this once a week. The study will last for about 5 years. Participants will have up to 21 clinic visits and 9 phone calls with the clinical sta
ClinicalTrials.gov · Mar 2021View trial ↗ Limited · human
This case report by Mallory, Lopategui, and Cordon (Sexual Medicine, 2021) describes a single patient who developed acute ischemic priapism following subcutaneous self-administration of Melanotan II, a synthetic melanocortin analog that is illicitly sold online and used in unlicensed clinics as a sunless tanning agent and sexual stimulant. The authors note that Melanotan II has also been investigated as a potential treatment for erectile dysfunction. In this case, standard first-line management — including cavernosal aspiration, irrigation, and intracavernous phenylephrine injection — failed to achieve detumescence. The patient ultimately required surgical intervention via penoscrotal decompression, which the authors describe as a promising technique for refractory ischemic priapism. The report notes that priapism associated with Melanotan II had only been documented twice previously in the literature. The authors conclude that priapism should be recognized as a possible adverse effect of Melanotan II and that future therapeutic investigations and clinical guidelines should account for this risk. Key limitations include the inherent constraints of a single case report: findings cannot be generalized, causality cannot be definitively established, and no controlled comparison is possible.
Sexual medicine · Jan 2021DOI ↗ Review
This systematic review examines the role of the zonulin pathway in regulating tight junction integrity and its contribution to increased epithelial and endothelial permeability across a range of chronic and acute inflammatory conditions. The authors searched PubMed and Google Scholar using terms related to Larazotide (also known as AT-1001, FZI/0, and INN-202), retrieving 209 publications, which were then filtered for relevance and English language. Findings were organized by disease area, including celiac disease, type 1 diabetes, other autoimmune diseases, inflammatory bowel disease, Kawasaki disease, respiratory diseases (both infectious and non-infectious), and miscellaneous conditions. The review concludes that evidence from both in vivo and in vitro studies supports a substantial role for zonulin dysregulation in these diseases, and suggests Larazotide — a zonulin antagonist — as a potentially viable therapeutic strategy. The authors also highlight newly identified molecular targets for Larazotide. Key limitations include the heterogeneity of the underlying studies (spanning animal models, in vitro work, and human trials of varying quality), and the review's broad scope may obscure differences in evidence quality across disease indications.
Current medicinal chemistry · Jan 2021DOI ↗ 🧪 TrialInsufficient
Registered observational trial (completed). The aim of this study is to evaluate whether exposure to semaglutide influences the risk of pancreatic cancer in patients with type 2 diabetes. This is achieved by estimating the risk of pancreatic cancer associated with semaglutide use as compared to use of other non-incretin antidiabetic drugs used at a similar stage as Ozempic® or Rybelsus® in the treatment of type 2 diabetes. A multi-national, non-interventional study based on health care data from Denmark, Sweden, and Norway is conducted covering the period 2018-2023. A cohort study design is us
ClinicalTrials.gov · Oct 2020View trial ↗ 🧪 TrialInsufficient
Registered Phase 1 interventional trial (completed). The objective of this study is to evaluate the safety, tolerance, pharmacokinetics and the potential immunological reaction of single intravenous recombinant human thymosin β4（NL005）or placebo 0.05, 0.25, 0.5, 2, 5, 12.5, 25μg/kg in Chinese healthy volunteers. 54 volunteers will be randomized to receive NL005 or placebo for 7 cohorts,administered iv by iv push on Day 1.
ClinicalTrials.gov · Sep 2020View trial ↗ 🧪 TrialInsufficient
Registered Phase 1 interventional trial (completed). The objective of this study is to evaluate the safety, tolerance, pharmacokinetics and the potential immunological reaction of single intravenous recombinant human thymosin β4（NL005）or placebo 0.5, 2.0,5.0μg/kg in Chinese healthy volunteers.30 volunteers will be randomly assigned to one of three groups to receive either NL005 or placebo for 10 consecutive days.
ClinicalTrials.gov · Sep 2020View trial ↗ Animal only
This animal study investigated whether ghrelin receptor agonists (ghrelin mimetics) could reduce visceral and somatic pain in the absence of active inflammation. Using a rat model, researchers induced non-inflammatory visceral hypersensitivity by infusing dilute acetic acid into the colon, and somatic mechanical allodynia was also assessed. Two ghrelin receptor agonists were tested: HM01, a centrally and peripherally active compound administered orally, and ipamorelin, a peripherally restricted compound administered intravenously. Pain responses were measured by counting abdominal muscle contractions during colorectal distension (visceral pain) and paw withdrawals to von Frey filament stimulation (somatic pain). The study found that both HM01 and ipamorelin significantly reduced colonic hypersensitivity and somatic allodynia compared to vehicle controls. These effects were reversed by co-administration of the ghrelin receptor antagonist H0900, confirming that the anti-nociceptive effects were receptor-mediated. Notably, the peripherally restricted compound ipamorelin was effective, suggesting peripheral ghrelin receptor activation may be sufficient. The study is limited by its exclusive use of an animal model, meaning translational relevance to humans remains unestablished. The authors propose ghrelin mimetics as a potential novel approach for treating acute visceral and somatic pain.
Journal of experimental pharmacology · Aug 2020DOI ↗ Review
This narrative review examines the potential adjunctive role of growth hormone secretagogues (GHS) in managing body composition changes associated with male hypogonadism and metabolic syndrome. The authors acknowledge that while testosterone replacement therapy remains the standard of care for hypogonadism, its body composition benefits are inconsistent across patient populations. The review surveys existing literature on five GHS compounds — sermorelin, GHRP-2, GHRP-6, ibutamoren (MK-677), and ipamorelin — noting that all stimulate growth hormone (GH) and insulin-like growth factor-1 (IGF-1) secretion and may improve body composition metrics such as reducing fat mass and attenuating muscle atrophy. The authors also explore their potential utility in eugonadal males with metabolic syndrome or subclinical hypogonadism. A major limitation explicitly acknowledged by the authors is the scarcity of robust clinical trial data evaluating these compounds specifically in hypogonadal men. The review concludes that while GHS show theoretical and preliminary promise as complementary agents, the current evidence base is insufficient to draw firm clinical conclusions, and the authors call for future controlled investigations. No new primary data are presented.
Translational andrology and urology · Mar 2020DOI ↗ Limited · human
This paper presents a case report combined with a literature review examining a possible association between Melanotan II (MTII) — a non-selective melanocortin-receptor agonist commonly used illicitly for skin tanning, penile erection, and sexual stimulation — and renal infarction. The authors describe a patient who experienced renal infarction most likely attributed to MTII use. Renal infarction, an uncommon and potentially life-threatening condition caused by acute disruption of renal blood flow, is noted to be frequently misdiagnosed or diagnosed late. The paper reviews prior literature documenting MTII-associated rhabdomyolysis and renal failure, and proposes two potential mechanisms of renal injury: a thrombotic pharmacological effect and possible direct toxic effects on renal parenchyma. Limitations are significant: evidence rests on a single case and a narrative review of prior case-level reports, meaning causality cannot be formally established. No controlled data are available, and the condition's rarity makes systematic study difficult. The authors conclude that MTII's thrombotic and potentially nephrotoxic properties warrant clinical awareness, particularly given the compound's widespread unregulated use.
CEN case reports · Jan 2020DOI ↗ 🧪 TrialInsufficient
Registered Phase 3 interventional trial (completed). The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.
ClinicalTrials.gov · May 2019View trial ↗ Review
This review paper examines the biological pathway linking growth hormone releasing peptides (GHRPs) — with a focus on the peptide hexarelin — to metabolic regulation via the scavenger receptor CD36 and the nuclear receptor PPARγ. The authors summarize evidence showing that GHRPs can activate PPARγ through CD36, and discuss how this pathway may influence key metabolic processes including atherosclerosis, hepatic cholesterol biosynthesis, and mitochondrial biogenesis in fat tissue. The paper also discusses the role of the PPARγ coactivator PGC-1 in mediating these downstream effects. The authors contextualize this pathway alongside established pharmacological approaches, such as thiazolidinediones, which also target PPARγ to improve insulin resistance in diabetic patients. The paper proposes that the GHRP-CD36-PPARγ axis represents a novel potential target for addressing metabolic disorders. As a review, the paper synthesizes existing preclinical and some clinical research but does not present original experimental data. Key limitations include the absence of new human trial data and the largely preclinical nature of much of the underlying evidence for hexarelin specifically.
International journal of molecular sciences · May 2018DOI ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (completed), with sponsor-posted results. Nonalcoholic fatty liver disease (NAFLD) is common in individuals with obesity and is a significant threat to public health, because it can lead to impaired liver function and liver failure. Growth hormone is a hormone produced in the pituitary gland that helps regulate metabolism and growth. Individuals with obesity, on average, secrete less growth hormone than individuals without obesity. There are data to suggest that growth hormone may help to reduce the amount of fat in the liver, and may also reduce inflamm
ClinicalTrials.gov · Dec 2017View trial ↗ 🧪 TrialInsufficient
Registered observational trial (active not recruiting). Empagliflozin, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, was launched as a treatment for type 2 diabetes mellitus (T2DM) in the U.S. in August 2014. In contrast with several previous cardiovascular outcomes trials, which failed to demonstrate an association with a higher or a lower risk of cardiovascular outcomes associated with members of other recently marketed antidiabetic classes, the EMPA-REG OUTCOME trial has shown that patients at high cardiovascular risk randomized to empagliflozin vs. placebo, were associated with a r
ClinicalTrials.gov · Dec 2017View trial ↗ 🧪 TrialInsufficient
Registered Phase 1 interventional trial (completed). The purpose of the study is to investigate the drug octreotide acetate in a new intranasal formulation and compare it to the FDA-approved subcutaneous (SC) injection formulation. The two octreotide acetate formulations will be evaluated following separate administrations for safety and tolerability including any side effects, the speed at which the drug is absorbed and eliminated in the body, and the ability of the drug to lower the levels of growth hormone (GH) and insulin-like growth factor 1 (IGF-1).
ClinicalTrials.gov · Jan 2017View trial ↗ 🧪 TrialInsufficient
Registered N/A interventional trial (completed). The purpose of this study was to validate the growth hormone releasing hormone (GHRH) plus arginine (GHRH+arg) stimulation test and it´s cut-off limits for diagnosis of adult growth hormone deficiency using the growth hormone (GH) Immulite 2000 Xpi assay calibrated against the IS 98/574 from the World Health Organization. A specific aim was to study the effect of gender and age on the peak GH response in the GHRH+arg test
ClinicalTrials.gov · Jan 2017View trial ↗ 🧪 TrialLimited · human
Registered Phase 3 interventional trial (completed), with sponsor-posted results. The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
ClinicalTrials.gov · Nov 2016View trial ↗ 🧪 TrialInsufficient
Registered Phase 3 interventional trial (unknown). 300 women with expected poor ovarian response (POR) undergoing in vitro fertilization or intra-cytoplasmic sperm injection (ICSI) will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Dehydroepiandrosterone (DHEA) 25 mg ( DHEA 25mg, Natrol , USA) t.d.s daily for 12 weeks before starting IVF/ICSI cycle and a placebo similar to growth hormone (GH) daily from day 6 of stimulation until the day of human chorionic gonadotrophin (hCG) trigger. Group 2 will receive an oral placebo t.d.s. daily for
ClinicalTrials.gov · Apr 2016View trial ↗ 🧪 TrialInsufficient
Registered Phase 1 interventional trial (unknown). Phase I clinical trial in healthy volunteers to study safety and pharmacokinetics of BPC-157, a pentadecapeptide from gastric source.
ClinicalTrials.gov · Dec 2015View trial ↗