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Home » PHASE1 » PHASE 1- MGL-3196 (VIA-3196)Madrigal Pharmaceuticals, to treat high cholesterol/high triglycerides

PHASE 1- MGL-3196 (VIA-3196)Madrigal Pharmaceuticals, to treat high cholesterol/high triglycerides

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MGL-3196 (VIA-3196)   photo credit The haystack  http://cenblog.org/the-haystack/tag/mgl-3196/
Madrigal Pharmaceuticals, acquired from VIA Pharmaceuticals, licensed from Roche to treat high cholesterol/high triglycerides , it mimics thyroid hormone, targeted to thyroid hormone receptor beta in the liver

Specifically, MGL-3196 is a thyroid hormone analog, designed to target a thyroid hormone receptor in the liver. These receptors regulate genes involved in cholesterol regulation and metabolism.

MGL-3196 is an orally administered, small-molecule liver-directed ß-selective THR agonist designed to specifically target receptors in the liver involved in metabolism and cholesterol regulation, and avoid side effects associated with thyroid hormone receptor activation outside the liver, including those mediated by THR-α receptors. MGL-3196 has currently completed Phase I single and multiple dose trials in healthy volunteers. MGL-3196 is being developed for dyslipidemia/hypercholesterolemia to lower LDL cholesterol, triglyceride levels and Lp(a), and was inlicensed from Roche Pharmaceuticals. MGL-3196 has excellent safety in comparative studies with other THR agonists tested previously because of MGL-3196’s high liver uptake and high ß-selectivity and nearly complete lack of THR-α activity.

MGL-3196 has completed a single ascending dose study in healthy volunteers in which the compound appeared safe at all doses tested. The multiple ascending dose study in healthy volunteers with mildly elevated LDL cholesterol was completed in October 2012 and provided additional safety and pharmacodynamic information. The Phase I multiple dose, proof of concept study enrolled 48 healthy volunteers with mildly elevated LDL cholesterol to evaluate the safety, pharmacokinetics and pharmacodynamics of MGL-3196 after two weeks of daily dosing. Results showed that MGL-3196 was well tolerated and appeared safe at all doses tested. Daily doses of 50-200 mg showed highly statistically significant reductions relative to placebo of up to 30% LDL-cholesterol (p=.05-<.0001; 28%, non-HDL cholesterol (p=.027-.0001); 24% Apolipoprotein B (p=.008-.0004); and strong trends and up to 60% reduction of triglycerides (range, p=.13-.016).

 

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DR ANTHONY CRASTO
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4 Comments

  1. saminakhan2001 says:

    Reblogged this on MEDCHEMEGYPT.

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DR ANTHONY CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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