{"product_id":"stamulumab-myo-029-10mg","title":"Stamulumab (MYO-029) 10mg","description":"\u003cp data-pm-slice=\"1 1 []\"\u003e\u003cspan style=\"color: rgb(255, 42, 0);\"\u003eDue to the nature of this product being a monoclonal antibody and thus must be manufactured and stored under stringent quality standards, order fulfillment requires additional processing time. Please allow 2–3 weeks for production, plus shipping time, to ensure we deliver a product that meets our quality and purity specifications.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp data-pm-slice=\"1 1 []\"\u003e\u003cstrong\u003e\u003cspan style=\"color: rgb(255, 42, 0);\"\u003e                                         \u003cspan style=\"text-decoration: underline;\"\u003eNOT \u003c\/span\u003e\u003c\/span\u003e\u003c\/strong\u003e\u003cspan style=\"text-decoration: underline;\"\u003e\u003cstrong\u003e\u003cspan style=\"color: rgb(255, 42, 0); text-decoration: underline;\"\u003eFOR HUMAN CONSUMPTION\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp data-end=\"444\" data-start=\"89\"\u003e\u003cstrong data-end=\"113\" data-start=\"89\"\u003eStamulumab (MYO-029)\u003c\/strong\u003e is a \u003cstrong data-end=\"159\" data-start=\"119\"\u003efully human monoclonal IgG1 antibody\u003c\/strong\u003e designed to \u003cstrong data-end=\"204\" data-start=\"172\"\u003eneutralize myostatin (GDF-8)\u003c\/strong\u003e, a member of the TGF-β superfamily that functions as a \u003cstrong data-end=\"315\" data-start=\"260\"\u003epotent negative regulator of skeletal muscle growth\u003c\/strong\u003e. By inhibiting myostatin, stamulumab was intended to promote \u003cstrong data-end=\"443\" data-start=\"377\"\u003eincreased muscle mass and potentially improved muscle function\u003c\/strong\u003e.\u003c\/p\u003e\n\u003cp data-end=\"581\" data-start=\"446\"\u003eThe molecule was developed by \u003cstrong data-end=\"485\" data-start=\"476\"\u003eWyeth\u003c\/strong\u003e (later Pfizer) and advanced into early clinical testing primarily for \u003cstrong data-end=\"580\" data-start=\"556\"\u003emuscular dystrophies\u003c\/strong\u003e.\u003c\/p\u003e\n\u003cp data-end=\"721\" data-start=\"583\"\u003e\u003cstrong data-end=\"605\" data-start=\"583\"\u003eRegulatory status:\u003c\/strong\u003e\u003cbr data-end=\"608\" data-start=\"605\"\u003eStamulumab is \u003cstrong data-end=\"666\" data-start=\"622\"\u003einvestigational and not FDA\/EMA-approved\u003c\/strong\u003e. Clinical development was ultimately \u003cstrong data-end=\"720\" data-start=\"704\"\u003ediscontinued\u003c\/strong\u003e.\u003c\/p\u003e\n\u003chr data-end=\"726\" data-start=\"723\"\u003e\n\u003ch3 data-end=\"778\" data-start=\"728\"\u003e2) Biological rationale: targeting myostatin\u003c\/h3\u003e\n\u003cp data-end=\"1105\" data-start=\"779\"\u003eMyostatin limits skeletal muscle growth by binding \u003cstrong data-end=\"877\" data-start=\"830\"\u003eactivin type II receptors (ActRIIA\/ActRIIB)\u003c\/strong\u003e, activating \u003cstrong data-end=\"911\" data-start=\"890\"\u003eSMAD2\/3 signaling\u003c\/strong\u003e, and suppressing anabolic muscle programs. Genetic loss-of-function models in animals—and rare human mutations—demonstrate dramatic increases in muscle mass when myostatin signaling is reduced.\u003c\/p\u003e\n\u003cp data-end=\"1169\" data-start=\"1107\"\u003eThis made myostatin an attractive, high-confidence target for:\u003c\/p\u003e\n\u003cul data-end=\"1263\" data-start=\"1170\"\u003e\n\u003cli data-end=\"1193\" data-start=\"1170\"\u003e\n\u003cp data-end=\"1193\" data-start=\"1172\"\u003emuscular dystrophies,\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-end=\"1222\" data-start=\"1194\"\u003e\n\u003cp data-end=\"1222\" data-start=\"1196\"\u003emuscle wasting conditions,\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-end=\"1263\" data-start=\"1223\"\u003e\n\u003cp data-end=\"1263\" data-start=\"1225\"\u003esarcopenia and cachexia (exploratory).\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp data-end=\"1478\" data-start=\"1265\"\u003eA key translational challenge recognized early in this field is that \u003cstrong data-end=\"1432\" data-start=\"1334\"\u003eincreased muscle mass does not necessarily translate into improved muscle strength or function\u003c\/strong\u003e, especially in chronic neuromuscular disease.\u003c\/p\u003e\n\u003chr data-end=\"1483\" data-start=\"1480\"\u003e\n\u003ch3 data-end=\"1513\" data-start=\"1485\"\u003e3) Mechanism of action\u003c\/h3\u003e\n\u003ch4 data-end=\"1547\" data-start=\"1515\"\u003e3.1 Ligand neutralization\u003c\/h4\u003e\n\u003cp data-end=\"1756\" data-start=\"1548\"\u003eStamulumab binds circulating \u003cstrong data-end=\"1590\" data-start=\"1577\"\u003emyostatin\u003c\/strong\u003e, preventing its interaction with ActRII receptors on skeletal muscle cells. This reduces downstream SMAD signaling and relieves repression of muscle growth pathways.\u003c\/p\u003e\n\u003ch4 data-end=\"1807\" data-start=\"1758\"\u003e3.2 Expected downstream effects (conceptual)\u003c\/h4\u003e\n\u003cul data-end=\"2006\" data-start=\"1808\"\u003e\n\u003cli data-end=\"1832\" data-start=\"1808\"\u003e\n\u003cp data-end=\"1832\" data-start=\"1810\"\u003e↓ SMAD2\/3 activation\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-end=\"1869\" data-start=\"1833\"\u003e\n\u003cp data-end=\"1869\" data-start=\"1835\"\u003e↑ myofiber hypertrophy signaling\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-end=\"1904\" data-start=\"1870\"\u003e\n\u003cp data-end=\"1904\" data-start=\"1872\"\u003e↑ lean muscle mass (PD signal)\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-end=\"2006\" data-start=\"1905\"\u003e\n\u003cp data-end=\"2006\" data-start=\"1907\"\u003eFunctional improvement \u003cstrong data-end=\"1941\" data-start=\"1930\"\u003eonly if\u003c\/strong\u003e neuromuscular integrity and mechanical loading permit adaptation\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003chr data-end=\"2011\" data-start=\"2008\"\u003e\n\u003ch3 data-end=\"2055\" data-start=\"2013\"\u003e4) Clinical development and evidence\u003c\/h3\u003e\n\u003ch4 data-end=\"2091\" data-start=\"2057\"\u003e4.1 Phase I\/II study design\u003c\/h4\u003e\n\u003cp data-end=\"2229\" data-start=\"2092\"\u003eStamulumab was evaluated in a \u003cstrong data-end=\"2170\" data-start=\"2122\"\u003ephase I\/II randomized, dose-escalation study\u003c\/strong\u003e involving \u003cstrong data-end=\"2217\" data-start=\"2181\"\u003eadults with muscular dystrophies\u003c\/strong\u003e, including:\u003c\/p\u003e\n\u003cul data-end=\"2344\" data-start=\"2230\"\u003e\n\u003cli data-end=\"2259\" data-start=\"2230\"\u003e\n\u003cp data-end=\"2259\" data-start=\"2232\"\u003eBecker muscular dystrophy\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-end=\"2309\" data-start=\"2260\"\u003e\n\u003cp data-end=\"2309\" data-start=\"2262\"\u003eFacioscapulohumeral muscular dystrophy (FSHD)\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-end=\"2344\" data-start=\"2310\"\u003e\n\u003cp data-end=\"2344\" data-start=\"2312\"\u003eLimb-girdle muscular dystrophy\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp data-end=\"2473\" data-start=\"2346\"\u003eThe trial focused on \u003cstrong data-end=\"2435\" data-start=\"2367\"\u003esafety, tolerability, pharmacokinetics, and exploratory efficacy\u003c\/strong\u003e endpoints (muscle mass and function).\u003c\/p\u003e\n\u003chr data-end=\"2478\" data-start=\"2475\"\u003e\n\u003ch4 data-end=\"2514\" data-start=\"2480\"\u003e4.2 Safety and tolerability\u003c\/h4\u003e\n\u003cp data-end=\"2650\" data-start=\"2515\"\u003eOverall, MYO-029 demonstrated an \u003cstrong data-end=\"2577\" data-start=\"2548\"\u003eacceptable safety profile\u003c\/strong\u003e in early trials. The most notable treatment-related adverse finding was:\u003c\/p\u003e\n\u003cul data-end=\"2753\" data-start=\"2651\"\u003e\n\u003cli data-end=\"2753\" data-start=\"2651\"\u003e\n\u003cp data-end=\"2753\" data-start=\"2653\"\u003e\u003cstrong data-end=\"2693\" data-start=\"2653\"\u003ecutaneous hypersensitivity reactions\u003c\/strong\u003e, particularly at \u003cstrong data-end=\"2727\" data-start=\"2711\"\u003ehigher doses\u003c\/strong\u003e (reported at 10–30 mg\/kg)\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp data-end=\"2844\" data-start=\"2755\"\u003eNo clear systemic toxicity signals emerged that would independently preclude development.\u003c\/p\u003e\n\u003chr data-end=\"2849\" data-start=\"2846\"\u003e\n\u003ch4 data-end=\"2897\" data-start=\"2851\"\u003e4.3 Efficacy outcomes: mass vs function\u003c\/h4\u003e\n\u003cul data-end=\"3389\" data-start=\"2898\"\u003e\n\u003cli data-end=\"3059\" data-start=\"2898\"\u003e\n\u003cp data-end=\"3059\" data-start=\"2900\"\u003e\u003cstrong data-end=\"2920\" data-start=\"2900\"\u003eMuscle function:\u003c\/strong\u003e\u003cbr data-end=\"2923\" data-start=\"2920\"\u003eNo statistically or clinically meaningful improvements were observed in functional endpoints such as strength or performance measures.\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-end=\"3389\" data-start=\"3061\"\u003e\n\u003cp data-end=\"3389\" data-start=\"3063\"\u003e\u003cstrong data-end=\"3101\" data-start=\"3063\"\u003eMuscle mass \/ biological activity:\u003c\/strong\u003e\u003cbr data-end=\"3104\" data-start=\"3101\"\u003eSome participants showed \u003cstrong data-end=\"3176\" data-start=\"3131\"\u003esignals suggestive of biological activity\u003c\/strong\u003e, including trends toward increased muscle size or lean mass (DXA and\/or histological measures). However, these changes were \u003cstrong data-end=\"3332\" data-start=\"3301\"\u003einconsistent and not robust\u003c\/strong\u003e, and they did \u003cstrong data-end=\"3388\" data-start=\"3347\"\u003enot translate into functional benefit\u003c\/strong\u003e.\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp data-end=\"3542\" data-start=\"3391\"\u003e\u003cstrong data-end=\"3421\" data-start=\"3391\"\u003eConclusion from the trial:\u003c\/strong\u003e\u003cbr data-end=\"3424\" data-start=\"3421\"\u003eStamulumab demonstrated \u003cstrong data-end=\"3479\" data-start=\"3448\"\u003eproof of biological concept\u003c\/strong\u003e, but \u003cstrong data-end=\"3541\" data-start=\"3485\"\u003efailed to demonstrate clinically meaningful efficacy\u003c\/strong\u003e.\u003c\/p\u003e\n\u003chr data-end=\"3547\" data-start=\"3544\"\u003e\n\u003ch3 data-end=\"3607\" data-start=\"3549\"\u003e5) PK\/PD limitations and reasons for discontinuation\u003c\/h3\u003e\n\u003cp data-end=\"3720\" data-start=\"3609\"\u003eSubsequent \u003cstrong data-end=\"3652\" data-start=\"3620\"\u003etranslational PK\/PD analyses\u003c\/strong\u003e provided a strong mechanistic explanation for the lack of efficacy:\u003c\/p\u003e\n\u003cul data-end=\"4254\" data-start=\"3722\"\u003e\n\u003cli data-end=\"3875\" data-start=\"3722\"\u003e\n\u003cp data-end=\"3875\" data-start=\"3724\"\u003e\u003cstrong data-end=\"3748\" data-start=\"3724\"\u003eSpecies potency gap:\u003c\/strong\u003e\u003cbr data-end=\"3751\" data-start=\"3748\"\u003eThe exposure required to achieve muscle effects in humans was substantially higher than predicted from preclinical models.\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-end=\"4052\" data-start=\"3877\"\u003e\n\u003cp data-end=\"4052\" data-start=\"3879\"\u003e\u003cstrong data-end=\"3914\" data-start=\"3879\"\u003eHigher-than-expected clearance:\u003c\/strong\u003e\u003cbr data-end=\"3917\" data-start=\"3914\"\u003eHuman clearance of MYO-029 was \u003cstrong data-end=\"4012\" data-start=\"3950\"\u003emore than twice that of a typical IgG1 monoclonal antibody\u003c\/strong\u003e, limiting sustained target suppression.\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-end=\"4254\" data-start=\"4054\"\u003e\n\u003cp data-end=\"4254\" data-start=\"4056\"\u003e\u003cstrong data-end=\"4091\" data-start=\"4056\"\u003eInsufficient target engagement:\u003c\/strong\u003e\u003cbr data-end=\"4094\" data-start=\"4091\"\u003eModeled steady-state concentrations (especially trough levels) were \u003cstrong data-end=\"4220\" data-start=\"4164\"\u003eunlikely to maintain continuous myostatin inhibition\u003c\/strong\u003e necessary for functional benefit.\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp data-end=\"4374\" data-start=\"4256\"\u003eIn short, \u003cstrong data-end=\"4336\" data-start=\"4266\"\u003eexposure and duration of myostatin blockade were likely inadequate\u003c\/strong\u003e, even at the highest tolerable doses.\u003c\/p\u003e\n\u003cp data-end=\"4457\" data-start=\"4376\"\u003eAs a result, development of stamulumab for muscular dystrophy was \u003cstrong data-end=\"4456\" data-start=\"4442\"\u003eterminated\u003c\/strong\u003e.\u003c\/p\u003e\n\u003chr data-end=\"4462\" data-start=\"4459\"\u003e\n\u003ch3 data-end=\"4517\" data-start=\"4464\"\u003e6) Broader implications for the myostatin field\u003c\/h3\u003e\n\u003cp data-end=\"4648\" data-start=\"4518\"\u003eStamulumab is now widely regarded as a \u003cstrong data-end=\"4597\" data-start=\"4557\"\u003efirst-generation myostatin inhibitor\u003c\/strong\u003e that provided critical lessons for later programs:\u003c\/p\u003e\n\u003cul data-end=\"4960\" data-start=\"4650\"\u003e\n\u003cli data-end=\"4705\" data-start=\"4650\"\u003e\n\u003cp data-end=\"4705\" data-start=\"4652\"\u003ePotent and sustained target engagement is essential\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-end=\"4764\" data-start=\"4706\"\u003e\n\u003cp data-end=\"4764\" data-start=\"4708\"\u003eMuscle mass increases alone are insufficient endpoints\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-end=\"4867\" data-start=\"4765\"\u003e\n\u003cp data-end=\"4867\" data-start=\"4767\"\u003eDisease context (fibrosis, denervation, fatty infiltration) strongly limits functional translation\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-end=\"4960\" data-start=\"4868\"\u003e\n\u003cp data-end=\"4960\" data-start=\"4870\"\u003eCombination approaches (rehabilitation, exercise, or multimodal therapies) may be required\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp data-end=\"5121\" data-start=\"4962\"\u003eThese insights influenced subsequent development of \u003cstrong data-end=\"5069\" data-start=\"5014\"\u003enext-generation myostatin\/ActRII pathway inhibitors\u003c\/strong\u003e, including ligand traps and alternative modalities.\u003c\/p\u003e\n\u003chr data-end=\"5126\" data-start=\"5123\"\u003e\n\u003ch3 data-end=\"5176\" data-start=\"5128\"\u003e7) Safety considerations (mechanism-based)\u003c\/h3\u003e\n\u003cp data-end=\"5279\" data-start=\"5177\"\u003eWhile MYO-029 itself showed limited toxicity, general considerations for myostatin inhibition include:\u003c\/p\u003e\n\u003cul data-end=\"5467\" data-start=\"5280\"\u003e\n\u003cli data-end=\"5350\" data-start=\"5280\"\u003e\n\u003cp data-end=\"5350\" data-start=\"5282\"\u003epotential imbalance between muscle mass and tendon\/joint adaptation,\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-end=\"5399\" data-start=\"5351\"\u003e\n\u003cp data-end=\"5399\" data-start=\"5353\"\u003euncertain long-term effects on muscle quality,\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-end=\"5467\" data-start=\"5400\"\u003e\n\u003cp data-end=\"5467\" data-start=\"5402\"\u003edisease-specific constraints in advanced neuromuscular disorders.\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp data-end=\"5577\" data-start=\"5469\"\u003eFor stamulumab specifically, \u003cstrong data-end=\"5528\" data-start=\"5498\"\u003ehypersensitivity reactions\u003c\/strong\u003e were the most clearly documented adverse signal.\u003c\/p\u003e","brand":"RCpeptides","offers":[{"title":"Default Title","offer_id":52684838469970,"sku":null,"price":4500.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1048\/0956\/2450\/files\/Stamulumab_10mg.png?v=1770834789","url":"https:\/\/sciencepeptideslab.com\/products\/stamulumab-myo-029-10mg","provider":"Science Peptides Lab","version":"1.0","type":"link"}