FDA Approves Ozempic (Semaglutide) for Type 2 Diabetes
FDA approval of Ozempic (semaglutide) injection for Type 2 diabetes, NDA 209637.
fda-ozempic-approval-2017Guide
Half-life is the time required for a measured concentration to decrease by half under a defined study condition. A reported value only applies within its formulation, route, population, assay, and sampling design. This table separates label-based and human pharmacokinetic estimates from animal findings, indirect references, and compounds with no reviewed human value. It does not translate half-life into an administration schedule. Missing data remain marked as missing rather than filled with community estimates.
The half-life values below are approximate ranges drawn from published literature. A single number rarely tells the full story because compounds can have distribution and elimination phases, nonlinear clearance, or formulation-specific behavior. 'FDA label' identifies approved prescribing information. 'Peer-reviewed PK study' identifies a published human pharmacokinetic study. 'Preclinical only' means the entry relies on animal or indirect evidence. 'Not well characterized' means no reliable human value is linked. A route shown in the table describes the cited source and is not a recommendation.
FDA approval of Ozempic (semaglutide) injection for Type 2 diabetes, NDA 209637.
fda-ozempic-approval-2017FDA-approved drug label for Egrifta (tesamorelin for injection), indicated for the reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy. The only GHRH/GHS-class peptide with FDA approval.
fda-egrifta-labelTeichman et al. (2006) pharmacokinetic study (PMID 16569233) showing that CJC-1295 increased GH and IGF-1 levels in healthy subjects for up to 6 days after a single dose. The primary published human data for CJC-1295.
pubmed-cjc1295-pharmacokinetics-2006This category includes the GLP-1 receptor agonists and the newer multi-incretin agonists (dual and triple receptor). These compounds are engineered for extended half-lives through amino acid modifications, fatty acid conjugation, and albumin binding, enabling once-weekly dosing for the longest-acting members. Native GLP-1 has a half-life of approximately 2 minutes due to rapid DPP-4 degradation; pharmaceutical GLP-1 agonists extend this by 80-fold or more.
FDA approval of Ozempic (semaglutide) injection for Type 2 diabetes, NDA 209637.
fda-ozempic-approval-2017FDA approval of Wegovy (semaglutide 2.4 mg) injection for chronic weight management, NDA 215256.
fda-wegovy-approval-2021FDA approval of Mounjaro (tirzepatide) injection for Type 2 diabetes, NDA 215866.
fda-mounjaro-approval-2022FDA approved Zepbound (tirzepatide) in November 2023 for chronic weight management in adults with obesity, used with diet and exercise. NDA 217806.
fda-zepbound-approval-2023Retatrutide phase 2 obesity trial (NEJM 2023): at 12 mg, mean body weight fell 17.5% at week 24 and 24.2% at week 48; GI adverse events were most common.
nejm-retatrutide-phase2-2023Phase 3 study NCT05882045 in participants with severe obesity and established cardiovascular disease. This is one study in the TRIUMPH program, not the TRIUMPH-1 pivotal obesity trial.
clinicaltrials-gov-retatrutide-triumphThis category includes GHRH analogs (tesamorelin, sermorelin, CJC-1295) and growth hormone secretagogues (ipamorelin, MK-677). GHRH analogs act on GHRH receptors at the pituitary; GHRPs and MK-677 act on the ghrelin (growth hormone secretagogue) receptor. These two pathways are pharmacologically distinct and can have additive effects. Half-lives in this category vary dramatically: from approximately 30 minutes for unmodified GHRH analogs to 8 days for CJC-1295 with the Drug Affinity Complex (DAC) modification.
Teichman et al. (2006) pharmacokinetic study (PMID 16569233) showing that CJC-1295 increased GH and IGF-1 levels in healthy subjects for up to 6 days after a single dose. The primary published human data for CJC-1295.
pubmed-cjc1295-pharmacokinetics-2006FDA-approved drug label for Egrifta (tesamorelin for injection), indicated for the reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy. The only GHRH/GHS-class peptide with FDA approval.
fda-egrifta-labelPivotal Phase 3 randomized trial (Falutz et al., 2010; PMID 20879920) showing tesamorelin significantly reduced visceral adipose tissue (VAT) over 26 weeks in HIV-infected patients with lipodystrophy. This trial supported FDA approval of Egrifta.
nejm-tesamorelin-phase3-2010PubMed index of clinical literature on sermorelin (Geref) for diagnostic testing of growth hormone deficiency in pediatric patients. Sermorelin was formerly FDA-approved as Geref; the brand product has been discontinued by the manufacturer.
pubmed-sermorelin-gh-deficiency-1997Raun et al. (1998) original pharmacology publication (PMID 9860070) describing ipamorelin as a pentapeptide growth hormone secretagogue with selectivity for GH release over cortisol and prolactin in animal models.
pubmed-ipamorelin-pharmacology-1998Svensson et al. (2000) study (PMID 10674575) demonstrating that oral MK-677 replicated the pulsatile GH profile seen with IV secretagogues in healthy older adults, with sustained IGF-1 increases over 4 weeks.
pubmed-mk677-gh-profile-2000Bach et al. (2002) 12-month Phase 2 trial (PMID 12004295) showing MK-677 improved functional status in elderly patients with hip fracture. Despite positive pharmacodynamic data, Merck did not advance MK-677 to FDA approval.
pubmed-mk677-hip-fracture-2002ClinicalTrials.gov registry entry (NCT01016781) for the MK-677 hip fracture recovery trial sponsored by Merck. MK-677 is not FDA-approved for any indication.
clinicaltrials-gov-mk677-hip-fractureThis category includes BPC-157 and TB-500 (thymosin beta-4), which are widely discussed in community contexts for injury recovery and tissue repair. A major limitation for both is the near-total absence of formal human pharmacokinetic data. Neither compound is FDA-approved, and published half-life values are not reliably established from human studies.
ClinicalTrials.gov registry search showing 100+ interventional studies of thymosin alpha-1 across infectious disease, oncology, and immune support contexts, including COVID-19 trials.
clinicaltrials-gov-thymosin-alpha-1This category includes peptides and peptide-derived nootropics studied for cognitive enhancement, neuroprotection, or attention. Many of these compounds (Semax, Selank, Noopept) were developed in Russia and have published clinical data primarily from Russian institutions, often without independent Western replication. Cerebrolysin is a porcine brain-derived peptide preparation with published European clinical trial data. Dihexa is a preclinical angiotensin IV analog with no human pharmacokinetic data. Half-life values for several of these compounds are estimated or derived from limited studies.
Russian-language clinical and preclinical publications on Semax (a heptapeptide ACTH analog) describing cognitive and attention-enhancing effects. Studies are primarily from Russian institutions and lack independent Western replication.
pubmed-semax-cognitive-2006Sedative-Hypnotic Agents That Impact Gamma-Aminobutyric Acid Receptors: Focus on Flunitrazepam, Gamma-Hydroxybutyric Acid, Phenibut, and Selank.
pubmed-selank-gaba-review-2021Functional Connectomic Approach to Studying Selank and Semax Effects.
pubmed-selank-functional-connectomics-2020[Noopept in the treatment of mild cognitive impairment in patients with stroke].
pubmed-noopept-stroke-mci-2011Physicochemical and structural analysis of N-phenylacetyl-L-prolylglycine ethyl ester (Noopept) - An active pharmaceutical ingredient with nootropic activity.
pubmed-noopept-physicochemical-2025Effect of nootropic dipeptide noopept on CA1 pyramidal neurons involves α7AChRs on interneurons in hippocampal slices from rat.
pubmed-noopept-hippocampal-achr-2022Cerebrolysin for vascular dementia
pubmed-cerebrolysin-cochrane-2019Safety and feasibility of cerebrolysin in treatment of primary intracerebral hemorrhage (CLINCH)-a prospective, randomized, open-label, blinded endpoint pilot trial
pubmed-cerebrolysin-clinch-2025Evaluation of metabolically stabilized angiotensin IV analogs as procognitive/antidementia agents.
pubmed-dihexa-mccoy-jpet-2013The procognitive and synaptogenic effects of angiotensin IV-derived peptides are dependent on activation of the hepatocyte growth factor/c-met system.
pubmed-dihexa-hgf-cmet-2014Provayblue (methylene blue) FDA Label - NDA 020226
fda-provayblue-labelMitochondrial respiration as a target for neuroprotection and cognitive enhancement
pubmed-methylene-blue-mitochondrial-2014Selective and membrane-permeable small molecule inhibitors of nicotinamide N-methyltransferase reverse high fat diet-induced obesity in mice
pubmed-nnmt-inhibitor-obesity-2018Topical cosmetic products require formulation-specific evidence about penetration, local exposure, stability, and residence time. A systemic plasma half-life may not answer the same question, but the absence of a human systemic estimate is still an evidence gap. The reviewed GHK-Cu sources include a topical clinical study and a broad skin-regeneration review; neither establishes a human systemic half-life.
Author-linked review of cellular, animal, skin-penetration, and cosmetic research involving GHK and GHK-Cu. The authors were affiliated with Skin Biology Research and Development, so the review is useful for mapping hypotheses but is not independent clinical efficacy evidence.
pubmed-ghk-skin-regeneration-review-2015Randomized topical study with 13 completers after CO2 laser resurfacing. Objective erythema, wrinkle, and overall skin-quality outcomes did not differ between groups, while patient satisfaction was higher with the GHK-Cu regimen.
pubmed-ghkcu-postlaser-2006Randomized, placebo-controlled four-week study of topical acetyl hexapeptide-8 in 60 Chinese participants. The small, short study reported subjective and skin-roughness outcomes and did not compare the product with botulinum toxin.
pubmed-argireline-clinical-2013Topical palmitoyl pentapeptide provides improvement in photoaged human facial skin
pubmed-palmitoyl-pentapeptide-clinical-2005Dermal Stability and In Vitro Skin Permeation of Collagen Pentapeptides (KTTKS and palmitoyl-KTTKS)
pubmed-kttks-permeation-2014ClinicalTrials.gov registry search for AOD-9604 clinical trials, including the Phase 2 obesity program by Metabolic Pharmaceuticals that failed to meet primary weight loss endpoints. AOD-9604 is not FDA-approved.
clinicaltrials-gov-aod-9604Heffernan MA et al. (2001) preclinical study (PMID 11285201) demonstrating that the C-terminal fragment of hGH (residues 177-191, the basis of AOD-9604) inhibits fat cell formation in 3T3-L1 cells, establishing the rationale for AOD-9604 as a lipolytic agent.
pubmed-heffernan-aod9604-2001This category includes peptides with immune-modulating or antimicrobial properties. Thymosin Alpha-1 is approved in over 30 countries (as Zadaxin) for hepatitis and immune adjuvant use, though not FDA-approved in the United States. LL-37 is the sole human cathelicidin antimicrobial peptide. KPV is an anti-inflammatory tripeptide derived from alpha-MSH with only preclinical data. Human pharmacokinetic data varies widely across this category.
King R, Tuthill C (2016) comprehensive review (PMID 26653168) of thymosin alpha-1's immune-modulating mechanism, clinical development history, and therapeutic applications including hepatitis, oncology, and sepsis.
pubmed-king-tuthill-2016SciClone Pharmaceuticals product information for Zadaxin (thymosin alpha-1), approved in over 30 countries for chronic hepatitis B, hepatitis C, and immune adjuvant use. Not FDA-approved in the United States.
sciclone-zadaxin-product-infoClinicalTrials.gov registry search showing 100+ interventional studies of thymosin alpha-1 across infectious disease, oncology, and immune support contexts, including COVID-19 trials.
clinicaltrials-gov-thymosin-alpha-1Dürr UHN, Sudheendra US, Ramamoorthy A (2006) foundational review (PMID 16459200) of LL-37 structure, mechanism, broad-spectrum antimicrobial activity, and role as the sole human cathelicidin.
pubmed-durr-ll37-2006Kahlenberg JM, Kaplan MJ (2013) review (PMID 23836012) of LL-37's dual role in innate immunity and autoimmunity, describing both protective antimicrobial effects and pro-inflammatory potential in autoimmune disease.
pubmed-kahlenberg-ll37-2013ClinicalTrials.gov registry search for interventional studies involving LL-37/cathelicidin, showing limited clinical trial activity. LL-37 is not FDA-approved for any indication.
clinicaltrials-gov-ll-37Preclinical studies of KPV (Lys-Pro-Val), a tripeptide derived from alpha-melanocyte-stimulating hormone (alpha-MSH), showing anti-inflammatory effects in animal models of intestinal and systemic inflammation. No human clinical trials have been published.
pubmed-kpv-anti-inflammatoryThis category includes compounds studied for longevity, metabolic health, and mitochondrial function. Most are small molecules or supplements rather than peptides, but are tracked on this site due to their overlap with the peptide research community. Pharmacokinetic data quality varies: metformin and rapamycin have well-established half-lives from FDA labels and decades of clinical use, while MOTS-c, Epitalon, and DSIP have limited or no reliable human pharmacokinetic data.
FDA-approved prescribing label for Rapamune (sirolimus), indicated for prophylaxis of organ rejection in kidney transplant patients and for the treatment of lymphangioleiomyomatosis (LAM).
fda-rapamune-labelLandmark NIA Interventions Testing Program (ITP) study showing that rapamycin, fed beginning at 600 days of age, significantly extended lifespan in genetically heterogeneous mice (both sexes).
nih-itr-rapamycin-lifespan-2009FDA label for Glucophage (metformin): indicated with diet and exercise to improve glycemic control in adults and children with type 2 diabetes.
fda-glucophage-metformin-labelClinicalTrials.gov: MILES (NCT02432287), pilot tied to TAME; randomized, double-blind metformin vs placebo in 16 adults, completed.
clinicaltrials-gov-tameRandomized, placebo-controlled trial (Yoshino et al., including Shin-ichiro Imai) showing that 10 weeks of NMN supplementation increased muscle insulin sensitivity in prediabetic women. A key human proof-of-concept study.
yoshino-2021-nmn-cellRandomized, double-blind trial (Dollerup et al.) showing that NR safely increased blood NAD+ in obese men but did not improve insulin sensitivity or body composition over 12 weeks, illustrating the biomarker-vs-outcome gap.
dollerup-2018-nr-humanFDA GRAS (Generally Recognized As Safe) notice response for nicotinamide riboside (NR) chloride, the ingredient in Tru Niagen, supporting its use as a dietary supplement ingredient.
niagen-gras-fda-2016FDA determination that NMN (nicotinamide mononucleotide) is excluded from the dietary supplement definition under DSHEA because it was first authorized for investigation as a new drug. This triggered marketplace disruption for NMN supplements.
fda-nmn-dshea-determination-2022Effects of Spermidine Supplementation on Cognition and Biomarkers in Older Adults With Subjective Cognitive Decline: A Randomized Clinical Trial
pubmed-spermidine-smartage-2022Mechanisms of spermidine-induced autophagy and geroprotection
pubmed-spermidine-autophagy-geroprotection-2022Fisetin for COVID-19 in skilled nursing facilities: Senolytic trials in the COVID era
pubmed-fisetin-senolytic-covid-2021Fisetin as a senotherapeutic agent: Evidence and perspectives for age-related diseases
pubmed-fisetin-senotherapeutic-review-2024Lee et al. (2015) landmark study (PMID 25754631) in Cell Metabolism identifying MOTS-c as a mitochondrial-derived peptide that regulates metabolic homeostasis, improves insulin sensitivity, and prevents obesity in mice fed a high-fat diet. Preclinical only.
pubmed-motsc-metabolic-lee-2015Emerging research on MOTS-c in the context of exercise physiology and aging, including observational human studies showing MOTS-c levels change with exercise. No interventional human trials confirming therapeutic effects.
pubmed-motsc-exercise-agingStudies by Khavinson and colleagues reporting that Epitalon (Ala-Glu-Asp-Gly) increases telomerase activity in human somatic cells. Research is primarily from a single Russian research group and lacks independent Western replication.
pubmed-epitalon-telomerase-khavinson-2003Reviews of Epitalon and related peptides in the context of aging biology, noting that telomerase and longevity claims rest on preclinical data from limited research groups without large-scale human clinical trials.
pubmed-epitalon-longevity-reviewClinical studies of delta sleep-inducing peptide (DSIP) in human sleep, dating to the 1970s-1980s, with mixed and inconclusive results. The DSIP clinical literature is old and has not been advanced with modern trials.
pubmed-dsip-clinical-sleep-1984Reviews of DSIP pharmacology describe it as a nonapeptide isolated from rabbit brain extract with reported sleep-modulating activity, though clinical significance remains unestablished.
pubmed-dsip-pharmacology-reviewThe half-life values in this table come from heterogeneous source types: FDA prescribing labels (the highest quality), peer-reviewed human pharmacokinetic studies, preclinical animal studies, and: for some entries: no reliable published data at all. Understanding these source quality differences is essential for interpreting the values correctly. Several recurring evidence gaps are worth noting.
FDA approval of Ozempic (semaglutide) injection for Type 2 diabetes, NDA 209637.
fda-ozempic-approval-2017FDA-approved drug label for Egrifta (tesamorelin for injection), indicated for the reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy. The only GHRH/GHS-class peptide with FDA approval.
fda-egrifta-labelFDA-approved prescribing label for Rapamune (sirolimus), indicated for prophylaxis of organ rejection in kidney transplant patients and for the treatment of lymphangioleiomyomatosis (LAM).
fda-rapamune-labelFDA label for Glucophage (metformin): indicated with diet and exercise to improve glycemic control in adults and children with type 2 diabetes.
fda-glucophage-metformin-labelTeichman et al. (2006) pharmacokinetic study (PMID 16569233) showing that CJC-1295 increased GH and IGF-1 levels in healthy subjects for up to 6 days after a single dose. The primary published human data for CJC-1295.
pubmed-cjc1295-pharmacokinetics-2006Retatrutide phase 2 obesity trial (NEJM 2023): at 12 mg, mean body weight fell 17.5% at week 24 and 24.2% at week 48; GI adverse events were most common.
nejm-retatrutide-phase2-2023Definitions of half-life, bioavailability, GHRH, GHRP, GLP-1, and other key pharmacokinetic and peptide vocabulary.
Understand HPLC, mass spectrometry, and purity data on peptide supplier documentation.
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FDA approval of Ozempic (semaglutide) injection for Type 2 diabetes, NDA 209637.
fda-ozempic-approval-2017FDA approval of Wegovy (semaglutide 2.4 mg) injection for chronic weight management, NDA 215256.
fda-wegovy-approval-2021FDA approval of Mounjaro (tirzepatide) injection for Type 2 diabetes, NDA 215866.
fda-mounjaro-approval-2022FDA approved Zepbound (tirzepatide) in November 2023 for chronic weight management in adults with obesity, used with diet and exercise. NDA 217806.
fda-zepbound-approval-2023Retatrutide phase 2 obesity trial (NEJM 2023): at 12 mg, mean body weight fell 17.5% at week 24 and 24.2% at week 48; GI adverse events were most common.
nejm-retatrutide-phase2-2023Phase 3 study NCT05882045 in participants with severe obesity and established cardiovascular disease. This is one study in the TRIUMPH program, not the TRIUMPH-1 pivotal obesity trial.
clinicaltrials-gov-retatrutide-triumphTeichman et al. (2006) pharmacokinetic study (PMID 16569233) showing that CJC-1295 increased GH and IGF-1 levels in healthy subjects for up to 6 days after a single dose. The primary published human data for CJC-1295.
pubmed-cjc1295-pharmacokinetics-2006FDA-approved drug label for Egrifta (tesamorelin for injection), indicated for the reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy. The only GHRH/GHS-class peptide with FDA approval.
fda-egrifta-labelPivotal Phase 3 randomized trial (Falutz et al., 2010; PMID 20879920) showing tesamorelin significantly reduced visceral adipose tissue (VAT) over 26 weeks in HIV-infected patients with lipodystrophy. This trial supported FDA approval of Egrifta.
nejm-tesamorelin-phase3-2010PubMed index of clinical literature on sermorelin (Geref) for diagnostic testing of growth hormone deficiency in pediatric patients. Sermorelin was formerly FDA-approved as Geref; the brand product has been discontinued by the manufacturer.
pubmed-sermorelin-gh-deficiency-1997Raun et al. (1998) original pharmacology publication (PMID 9860070) describing ipamorelin as a pentapeptide growth hormone secretagogue with selectivity for GH release over cortisol and prolactin in animal models.
pubmed-ipamorelin-pharmacology-1998Svensson et al. (2000) study (PMID 10674575) demonstrating that oral MK-677 replicated the pulsatile GH profile seen with IV secretagogues in healthy older adults, with sustained IGF-1 increases over 4 weeks.
pubmed-mk677-gh-profile-2000Bach et al. (2002) 12-month Phase 2 trial (PMID 12004295) showing MK-677 improved functional status in elderly patients with hip fracture. Despite positive pharmacodynamic data, Merck did not advance MK-677 to FDA approval.
pubmed-mk677-hip-fracture-2002ClinicalTrials.gov registry entry (NCT01016781) for the MK-677 hip fracture recovery trial sponsored by Merck. MK-677 is not FDA-approved for any indication.
clinicaltrials-gov-mk677-hip-fractureRussian-language clinical and preclinical publications on Semax (a heptapeptide ACTH analog) describing cognitive and attention-enhancing effects. Studies are primarily from Russian institutions and lack independent Western replication.
pubmed-semax-cognitive-2006Sedative-Hypnotic Agents That Impact Gamma-Aminobutyric Acid Receptors: Focus on Flunitrazepam, Gamma-Hydroxybutyric Acid, Phenibut, and Selank.
pubmed-selank-gaba-review-2021[Noopept in the treatment of mild cognitive impairment in patients with stroke].
pubmed-noopept-stroke-mci-2011Physicochemical and structural analysis of N-phenylacetyl-L-prolylglycine ethyl ester (Noopept) - An active pharmaceutical ingredient with nootropic activity.
pubmed-noopept-physicochemical-2025Cerebrolysin for vascular dementia
pubmed-cerebrolysin-cochrane-2019Evaluation of metabolically stabilized angiotensin IV analogs as procognitive/antidementia agents.
pubmed-dihexa-mccoy-jpet-2013Provayblue (methylene blue) FDA Label - NDA 020226
fda-provayblue-labelSelective and membrane-permeable small molecule inhibitors of nicotinamide N-methyltransferase reverse high fat diet-induced obesity in mice
pubmed-nnmt-inhibitor-obesity-2018Author-linked review of cellular, animal, skin-penetration, and cosmetic research involving GHK and GHK-Cu. The authors were affiliated with Skin Biology Research and Development, so the review is useful for mapping hypotheses but is not independent clinical efficacy evidence.
pubmed-ghk-skin-regeneration-review-2015Randomized topical study with 13 completers after CO2 laser resurfacing. Objective erythema, wrinkle, and overall skin-quality outcomes did not differ between groups, while patient satisfaction was higher with the GHK-Cu regimen.
pubmed-ghkcu-postlaser-2006Randomized, placebo-controlled four-week study of topical acetyl hexapeptide-8 in 60 Chinese participants. The small, short study reported subjective and skin-roughness outcomes and did not compare the product with botulinum toxin.
pubmed-argireline-clinical-2013Topical palmitoyl pentapeptide provides improvement in photoaged human facial skin
pubmed-palmitoyl-pentapeptide-clinical-2005ClinicalTrials.gov registry search for AOD-9604 clinical trials, including the Phase 2 obesity program by Metabolic Pharmaceuticals that failed to meet primary weight loss endpoints. AOD-9604 is not FDA-approved.
clinicaltrials-gov-aod-9604King R, Tuthill C (2016) comprehensive review (PMID 26653168) of thymosin alpha-1's immune-modulating mechanism, clinical development history, and therapeutic applications including hepatitis, oncology, and sepsis.
pubmed-king-tuthill-2016SciClone Pharmaceuticals product information for Zadaxin (thymosin alpha-1), approved in over 30 countries for chronic hepatitis B, hepatitis C, and immune adjuvant use. Not FDA-approved in the United States.
sciclone-zadaxin-product-infoDürr UHN, Sudheendra US, Ramamoorthy A (2006) foundational review (PMID 16459200) of LL-37 structure, mechanism, broad-spectrum antimicrobial activity, and role as the sole human cathelicidin.
pubmed-durr-ll37-2006Preclinical studies of KPV (Lys-Pro-Val), a tripeptide derived from alpha-melanocyte-stimulating hormone (alpha-MSH), showing anti-inflammatory effects in animal models of intestinal and systemic inflammation. No human clinical trials have been published.
pubmed-kpv-anti-inflammatoryFDA-approved prescribing label for Rapamune (sirolimus), indicated for prophylaxis of organ rejection in kidney transplant patients and for the treatment of lymphangioleiomyomatosis (LAM).
fda-rapamune-labelFDA label for Glucophage (metformin): indicated with diet and exercise to improve glycemic control in adults and children with type 2 diabetes.
fda-glucophage-metformin-labelRandomized, placebo-controlled trial (Yoshino et al., including Shin-ichiro Imai) showing that 10 weeks of NMN supplementation increased muscle insulin sensitivity in prediabetic women. A key human proof-of-concept study.
yoshino-2021-nmn-cellRandomized, double-blind trial (Dollerup et al.) showing that NR safely increased blood NAD+ in obese men but did not improve insulin sensitivity or body composition over 12 weeks, illustrating the biomarker-vs-outcome gap.
dollerup-2018-nr-humanFDA GRAS (Generally Recognized As Safe) notice response for nicotinamide riboside (NR) chloride, the ingredient in Tru Niagen, supporting its use as a dietary supplement ingredient.
niagen-gras-fda-2016FDA determination that NMN (nicotinamide mononucleotide) is excluded from the dietary supplement definition under DSHEA because it was first authorized for investigation as a new drug. This triggered marketplace disruption for NMN supplements.
fda-nmn-dshea-determination-2022Effects of Spermidine Supplementation on Cognition and Biomarkers in Older Adults With Subjective Cognitive Decline: A Randomized Clinical Trial
pubmed-spermidine-smartage-2022Fisetin for COVID-19 in skilled nursing facilities: Senolytic trials in the COVID era
pubmed-fisetin-senolytic-covid-2021Lee et al. (2015) landmark study (PMID 25754631) in Cell Metabolism identifying MOTS-c as a mitochondrial-derived peptide that regulates metabolic homeostasis, improves insulin sensitivity, and prevents obesity in mice fed a high-fat diet. Preclinical only.
pubmed-motsc-metabolic-lee-2015Studies by Khavinson and colleagues reporting that Epitalon (Ala-Glu-Asp-Gly) increases telomerase activity in human somatic cells. Research is primarily from a single Russian research group and lacks independent Western replication.
pubmed-epitalon-telomerase-khavinson-2003Clinical studies of delta sleep-inducing peptide (DSIP) in human sleep, dating to the 1970s-1980s, with mixed and inconclusive results. The DSIP clinical literature is old and has not been advanced with modern trials.
pubmed-dsip-clinical-sleep-1984