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<meta name="citation_inbook_title" content="LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]">
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yet</button><a id="jr-fip-next" class="wsprkl btn" title="Jump to next match">▶</a></nav></nav></div><div id="jr-epub-interstitial" class="hidden"></div><div id="jr-content"><article data-type="main"><div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><div class="fm-sec"><h1 id="_NBK604849_"><span class="title" itemprop="name">Somapacitan</span></h1><p class="fm-aai"><a href="#_NBK604849_pubdet_">Publication Details</a></p></div></div><div class="body-content whole_rhythm" itemprop="text"><div id="Somapacitan.OVERVIEW"><h2 id="_Somapacitan_OVERVIEW_">OVERVIEW</h2><div id="Somapacitan.Introduction"><h3>Introduction</h3><p>Somapacitan is a long acting, recombinant growth hormone analog that is used to treat adults and children two years of age or older with growth hormone deficiency. Somapacitan has not been linked to elevations in serum aminotransferase levels or bilirubin levels during therapy or to instances of clinically apparent liver injury with symptoms or jaundice.</p></div><div id="Somapacitan.Background"><h3>Background</h3><p>Somapacitan (soe” ma pas’ i tan) is a long acting, recombinant form of human growth hormone that is used to treat both adults and children with growth hormone deficiency. Human growth hormone (GH) is a 191-amino acid polypeptide produced by the pituitary gland that has widespread effects on many organs and tissues either directly via growth hormone receptors or indirectly via production of insulin like growth factor-1 (IGF-1) by the liver. Deficiency in growth hormone is associated with short stature and abnormalities in body composition and metabolic factors. Replacement with recombinant human growth factor preparations can correct these abnormalities, increasing linear growth in children as well as increasing muscle and bone growth and decreasing fat mass. Somapacitan differs from typical recombinant human growth factor (somatotropin) in being administered weekly rather than daily by subcutaneous injection. Somapacitan is a slightly modified analog with amino acid 109 being changed to a cysteine with a long side chain with an albumin binding receptor. In the circulation, somapacitan binds to albumin which prolongs its half-life allowing for once weekly administration. In a registration randomized controlled trial in adults, somapacitan led to increases in serum IGF-1 levels, increases in lean body mass, and reduction in total body fat percentage, thus correcting abnormalities in body composition associated with growth hormone deficiency. In pediatric trials, somapacitan led to improvements in growth and physical development compatible with correction of growth hormone deficiency. For both children and adults, changes in body composition with somapacitan therapy were similar to those achieved with FDA approved recombinant growth hormone products that required daily administration. Somapacitan was approved in the United States in 2020 for treatment of adults with growth hormone deficiency. In 2023, the indications were extended to children 2.5 years of age or older with growth failure due to inadequate endogenous growth hormone secretion. Somapacitan is available in solution in self-injection pens of 5, 10, or 15 mg in 1.5 mL of normal saline under the brand name Sogroya. Somapacitan is administered subcutaneously once weekly. The recommended dose is based upon age and body weight and is titrated up from an initial low dose based upon clinical response, IGF-1 levels, and patient tolerance. Somapacitan therapy should be prescribed and supervised by a physician who is experienced in the diagnosis and management of growth hormone deficiency. Common side effects include back pain, arthralgia, dyspepsia, sleep disorder, dizziness, peripheral edema, nausea and vomiting, systemic arterial hypertension, weight gain, and anemia. Rare potentially severe adverse effects may include increased risk of malignancy, glucose intolerance and diabetes, intracranial hypertension, hypersensitivity reactions, marked fluid retention, hypoadrenalism, hypothyroidism, pancreatitis, and lipohypertrophy or lipoatrophy at the sites of administration.</p><p>Somapacitan is a long acting recombinant human growth hormone analog. Other FDA approved therapies of growth hormone deficiency include recombinant growth hormone products (somatotropins) that are administered daily. Switching daily therapy to weekly injections of somapacitan can be done but requires careful titration and individualization of the weekly doses.</p></div><div id="Somapacitan.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>In preregistration trials, discussion of adverse events rarely mentioned serum aminotransferase elevations and did not report instances of clinically apparent liver injury. Somapacitan has been usually described as well tolerated with only mild or moderate adverse events, the majority of which were considered unrelated to treatment and occurred at similar rates in placebo recipients or subjects treated with recombinant growth hormone products requiring daily injections. Since its licensure and more widescale clinical use, there have been no published reports of acute liver injury attributed to somapacitan.</p><p>Likelihood score: E (unlikely cause of clinically apparent liver injury).</p></div><div id="Somapacitan.Mechanism_of_Injury"><h3>Mechanism of Injury</h3><p>Liver test abnormalities are rare during somapacitan therapy and are generally considered unrelated to the recombinant protein. The lack of liver injury during somapacitan therapy is probably because it is metabolized by tissue proteases to short polypeptides or amino acids and does not interact with hepatic cytochrome P450 enzymes.</p></div><div id="Somapacitan.Outcome_and_Management"><h3>Outcome and Management</h3><p>The product label for somapacitan does not recommend monitoring of routine liver tests during therapy. A rise in serum aminotransferase levels or bilirubin during therapy should trigger evaluation for other possible causes.</p><p>Drug Class: <a href="/books/n/livertox/Lipid-LoweringAgents/?report=reader">Growth Hormone Deficiency Agents </a></p></div></div><div id="Somapacitan.PRODUCT_INFORMATION"><h2 id="_Somapacitan_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><p>
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<b>REPRESENTATIVE TRADE NAMES</b>
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</p><p>Somapacitan – Sogroya®</p><p>
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<b>DRUG CLASS</b>
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</p><p>Human Growth Hormone Deficiency Agents</p><p>
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<a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Somapacitan" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">COMPLETE LABELING</a>
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</p><p>Product labeling at DailyMed, National Library of Medicine, NIH</p></div><div id="Somapacitan.CHEMICAL_FORMULA_AND_STRUCTU"><h2 id="_Somapacitan_CHEMICAL_FORMULA_AND_STRUCTU_">CHEMICAL FORMULA AND STRUCTURE</h2><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figSomapacitanTc"><a href="/books/NBK604849/table/Somapacitan.Tc/?report=objectonly" target="object" title="Table" class="img_link icnblk_img" rid-ob="figobSomapacitanTc"><img class="small-thumb" src="/corehtml/pmc/css/bookshelf/2.26/img/table-icon.gif" alt="Table Icon" /></a><div class="icnblk_cntnt"><h4 id="Somapacitan.Tc"><a href="/books/NBK604849/table/Somapacitan.Tc/?report=objectonly" target="object" rid-ob="figobSomapacitanTc">Table</a></h4></div></div></div><div id="Somapacitan.BIBLIOGRAPHY"><h2 id="_Somapacitan_BIBLIOGRAPHY_">BIBLIOGRAPHY</h2><p>References updated: 01 July 2024</p><p>Abbreviations: IGF-1, insulin like growth factor-1; ULN, upper limit of the normal range.</p><ul class="first-line-outdent"><li><div class="bk_ref" id="Somapacitan.REF1">FDA. Clinical Review. 2020. <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761156Orig1s000MedR.pdf" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https://www<wbr style="display:inline-block"></wbr>​.accessdata<wbr style="display:inline-block"></wbr>​.fda.gov/drugsatfda_docs<wbr style="display:inline-block"></wbr>​/nda/2020/761156Orig1s000MedR.pdf</a><div><i>(Summary of the data the safety and efficacy of somapacitan submitted in support of its approval as therapy of growth hormone deficiency, makes no specific mention of serum aminotransferase or bilirubin elevations, and after discussion of IGF-1 and glucose levels during treatment states “no other clinically relevant changes in other biochemistry parameters were observed”).</i></div></div></li><li><div class="bk_ref" id="Somapacitan.REF.johannsson.2018.491">Johannsson
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G, Feldt-Rasmussen
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U, Håkonsson
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IH, Biering
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H, Rodien
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P, Tahara
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S, Toogood
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A, et al.; REAL 2 Study Group. Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial.
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Eur J Endocrinol.
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2018;178:491-499.
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[<a href="/pmc/articles/PMC5920019/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5920019</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/29500310" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29500310</span></a>]<div><i>(Among 92 adults with growth hormone deficiency on once daily growth hormone therapy who were randomized to receive weekly injections of somapacitan vs daily norditropin for 26 weeks, IGF-1 levels were maintained in the normal range with both agents, adverse events rates were similar, and there were “no clinically relevant changes…in clinical laboratory measurements”).</i></div></div></li><li><div class="bk_ref" id="Somapacitan.REF.s_vendahl.2020.e1847">Sävendahl
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L, Battelino
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T, Brod
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M, Højby Rasmussen
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M, Horikawa
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R, Juul
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RV, Saenger
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P; REAL 3 study group. Once-weekly somapacitan vs daily GH in children with GH deficiency: results from a randomized phase 2 trial.
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J Clin Endocrinol Metab.
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2020;105:e1847–61.
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[<a href="/pmc/articles/PMC7069655/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC7069655</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/31917835" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31917835</span></a>]<div><i>(Among 59 previously untreated, pre-pubertal children with growth hormone deficiency treated with one of 3 doses of once weekly somapacitan or daily growth hormone, height velocity was greater with the highest dose of somapacitan [12.9 vs 11.4 cm per year], while adverse event rates were similar and there were “no clinically relevant findings” in laboratory measurements).</i></div></div></li><li><div class="bk_ref" id="Somapacitan.REF.johannsson.2020.e1358">Johannsson
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G, Gordon
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MB, Højby Rasmussen
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M, Håkonsson
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IH, Karges
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W, Sværke
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C, Tahara
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S, et al.
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Once-weekly somapacitan is effective and well tolerated in adults with GH deficiency: a randomized phase 3 trial.
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J Clin Endocrinol Metab.
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2020;105:e1358–76.
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[<a href="/pmc/articles/PMC7076631/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC7076631</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/32022863" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 32022863</span></a>]<div><i>(Among 301 adults with growth hormone deficiency treated with somapacitan weekly vs recombinant growth hormone daily vs placebo for 34 weeks, improvements in truncal fat percentage and IGF-1 levels were similar with both forms of growth hormone in comparison to placebo, and both total and serious adverse event rates were similar in the three groups and there were no hepatic severe adverse events; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Somapacitan.REF.miller.2022.3378">Miller
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BS, Blair
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JC, Rasmussen
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MH, Maniatis
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A, Kildemoes
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RJ, Mori
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J, Polak
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M, et al.
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Weekly somapacitan is effective and well tolerated in children With GH deficiency: the randomized phase 3 REAL4 trial.
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J Clin Endocrinol Metab.
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2022;107:3378-3388.
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[<a href="/pmc/articles/PMC9693810/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC9693810</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/36062966" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 36062966</span></a>]<div><i>(Among 200 children with prepubertal growth hormone deficiency treated with somapacitan or daily recombinant growth hormone [somatropin] for 52 weeks followed by open-label somapacitan for up to 4 years, the increase in height velocity was similar with both forms of growth hormone and adverse events were largely mild-to-moderate and considered unrelated to therapy; there were no discontinuations or deaths attributed to therapy; no mention of ALT levels or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Somapacitan.REF.s_vendahl.2023.2569">Sävendahl
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L, Battelino
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T, Højby Rasmussen
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M, Brod
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M, Röhrich
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S, Saenger
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P, Horikawa
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R.
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Weekly somapacitan in GH deficiency: 4-year efficacy, safety, and treatment/disease burden results from REAL 3.
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J Clin Endocrinol Metab.
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2023;108:2569-2578.
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[<a href="/pmc/articles/PMC10505532/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC10505532</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/36995872" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 36995872</span></a>]<div><i>(Among 50 prepubertal children enrolled in a long term open-label safety evaluation study with 4 years of follow up, no new safety signals were identified and there were no treatment related serious adverse events; no mention of ALT elevations but one child was said to have nonalcoholic fatty liver disease).</i></div></div></li><li><div class="bk_ref" id="Somapacitan.REF.miller.2023.3090">Miller
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BS, Blair
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JC, Rasmussen
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MH, Maniatis
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A, Mori
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J, Böttcher
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V, Kim
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HS, et al.
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Effective GH replacement with somapacitan in children with GHD: REAL4 2-year results and after switch from daily GH.
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J Clin Endocrinol Metab.
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2023;108:3090-3099.
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[<a href="/pmc/articles/PMC10655534/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC10655534</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/37406251" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 37406251</span></a>]<div><i>(Among 194 children with growth hormone deficiency treated with once weekly somapacitan or once daily growth hormone for one year followed by somapacitan in all patients for another year, height velocity improved and IGF-1 levels normalized in both groups and were maintained for 2 years, and while both therapies were well tolerated, once weekly somapacitan was preferred and there were no treatment related serious adverse events or discontinuations).</i></div></div></li></ul></div><p>Sponsor: Novo Nordisk, Inc</p><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK604849_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Update: <span itemprop="dateModified">July 1, 2024</span>.</p><h3>Copyright</h3><div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright Notice</a></div></div><h3>Publisher</h3><p><a href="https://www.niddk.nih.gov/" ref="pagearea=page-banner&targetsite=external&targetcat=link&targettype=publisher">National Institute of Diabetes and Digestive and Kidney Diseases</a>, Bethesda (MD)</p><h3>NLM Citation</h3><p>LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Somapacitan. [Updated 2024 Jul 1].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/livertox/Solriamfetol/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M75,30 c-80,60 -80,0 0,60 c-30,-60 -30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Prev</text></svg></a></div><div class="small-screen-next"><a href="/books/n/livertox/Sonidegib/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M25,30c80,60 80,0 0,60 c30,-60 30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Next</text></svg></a></div></article><article data-type="table-wrap" id="figobSomapacitanTc"><div id="Somapacitan.Tc" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK604849/table/Somapacitan.Tc/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Somapacitan.Tc_lrgtbl__"><table><thead><tr><th id="hd_h_Somapacitan.Tc_1_1_1_1" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">DRUG</th><th id="hd_h_Somapacitan.Tc_1_1_1_2" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CAS REGISTRY NUMBER</th><th id="hd_h_Somapacitan.Tc_1_1_1_3" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MOLECULAR FORMULA</th><th id="hd_h_Somapacitan.Tc_1_1_1_4" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">STRUCTURE</th></tr></thead><tbody><tr><td headers="hd_h_Somapacitan.Tc_1_1_1_1" scope="row" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Somapacitan</td><td headers="hd_h_Somapacitan.Tc_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<a href="https://pubchem.ncbi.nlm.nih.gov/substance/347810964" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem">1338578-34-9</a>
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</td><td headers="hd_h_Somapacitan.Tc_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">C54-H95-N13-O20-S2</td><td headers="hd_h_Somapacitan.Tc_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<a href="https://pubchem.ncbi.nlm.nih.gov/substance/347810964" title="View this structure in PubChem" class="img_link" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem"><img src="https://pubchem.ncbi.nlm.nih.gov/image/imgsrv.fcgi?t=l&sid=347810964" alt="image 347810964 in the ncbi pubchem database" /></a>
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