{"shortAnswer":"CagriSema is investigational: it is still in clinical trials, and FDA has not approved it. It combines cagrilintide with semaglutide. Its maker has asked FDA for approval, which is not the same as approval. The evidence grade is moderate-human for weight loss. Pharmacies may not make it.","url":"https://peptideindex.ai/compound/cagrisema","status":"investigational","statusCheckedAt":"2026-10-25T06:27:05.613Z","statusStale":false,"regulatoryAsOf":"2026-10-24","verified":"2026-10-25T06:27:05.656Z","primarySourceUrl":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","clinicallyReviewed":false,"notice":"Information, not medical advice.","id":"c8b20dee-4e52-409d-a514-38f2ba733581","object":"compound","slug":"cagrisema","name":"CagriSema","attrs":{"name":"CagriSema","class":"amylin-analog","access":[{"type":"clinical-trial","detail":"CagriSema is only available inside clinical trials. On 24 October 2026 this page checked one registry record of a study open to new people. Its US sites were not yet recruiting.","source_url":"https://clinicaltrials.gov/study/NCT07564414"}],"trials":[{"nct":"NCT07817251","url":"https://clinicaltrials.gov/study/NCT07817251","phase":"Phase 3","title":"Research Study on How People With Type 2 Diabetes Tolerate Switching From Semaglutide to Cagrisema","status":"recruiting","sponsor":"Novo Nordisk A/S","countries":["United States"],"us_states":["Arizona","California","Connecticut","Florida","Hawaii","Illinois","Iowa","Kansas","Michigan","Nevada","New Mexico","North Carolina","Ohio","Tennessee","Texas","Utah","Virginia"]},{"nct":"NCT07745504","url":"https://clinicaltrials.gov/study/NCT07745504","phase":"Phase 3","title":"A Research Study to Compare Two Different Versions of Injectable Cagrilintide and Placebo in People With Excess Body Weight","status":"recruiting","sponsor":"Novo Nordisk A/S","countries":["United States","Greece","Hungary","Portugal","Serbia","Sweden"],"us_states":["Georgia","Hawaii","Illinois","Indiana","Kentucky","North Carolina","South Carolina","Virginia"]},{"nct":"NCT07282613","url":"https://clinicaltrials.gov/study/NCT07282613","phase":"Phase 3","title":"A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Diabetes","status":"recruiting","sponsor":"Novo Nordisk A/S","countries":["United States","Argentina","Brazil","Colombia","India","Israel","Malaysia","Mexico","Taiwan","Thailand"],"us_states":["Connecticut","Florida","Georgia","Illinois","Indiana","Iowa","Michigan","New York","Pennsylvania","South Dakota","Tennessee","Texas","Virginia","Washington"]},{"nct":"NCT07564414","url":"https://clinicaltrials.gov/study/NCT07564414","phase":"Phase 3","title":"A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight","status":"recruiting","sponsor":"Novo Nordisk A/S","countries":["United States","Argentina","Australia","Austria","Belgium","Bulgaria","Canada","Czechia","France","Greece","Hungary","Italy","Netherlands","Poland","Portugal","Romania","Slovakia","South Africa","Spain"],"us_states":["Alabama","Arizona","Arkansas","California","Colorado","Florida","Georgia","Idaho","Illinois","Iowa","Kansas","Kentucky","Maryland","Michigan","Minnesota","Mississippi","Missouri","New York","North Carolina","North Dakota","Ohio","Oklahoma","Pennsylvania","Rhode Island","South Carolina","Tennessee","Texas","Utah","Virginia","Wisconsin"]},{"nct":"NCT07597018","url":"https://clinicaltrials.gov/study/NCT07597018","phase":"Phase 1","title":"A Research Study to Compare Blood Levels of Cagrilintide After Multiple Doses of Different Versions of Cagrilintide in Adults With Overweight or Obesity","status":"recruiting","sponsor":"Novo Nordisk A/S","countries":["Germany"],"us_states":[]},{"nct":"NCT07527195","url":"https://clinicaltrials.gov/study/NCT07527195","phase":"Phase 1","title":"Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscle Health)","status":"recruiting","sponsor":"Novo Nordisk A/S","countries":["Denmark"],"us_states":[]},{"nct":"NCT07253285","url":"https://clinicaltrials.gov/study/NCT07253285","phase":"Phase 3","title":"A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight","status":"recruiting","sponsor":"Novo Nordisk A/S","countries":["United States","Australia","Austria","Belgium","Bulgaria","China","Colombia","Croatia","Denmark","Hungary","India","Israel","Italy","Malaysia","Mexico","Netherlands","Poland","Portugal","Romania","Serbia","Slovakia","Spain","Sweden","Taiwan","Thailand","United Kingdom"],"us_states":["California","Florida","Georgia","Idaho","Indiana","Kansas","Louisiana","Maryland","Minnesota","New York","North Dakota","Ohio","Oklahoma","Pennsylvania","South Carolina","South Dakota","Tennessee","Texas","Utah"]},{"nct":"NCT07010432","url":"https://clinicaltrials.gov/study/NCT07010432","phase":"Phase 1","title":"The Role of the Amylin Analogue Cagrilintide in Bone Metabolism","status":"recruiting","sponsor":"Novo Nordisk A/S","countries":["Denmark"],"us_states":[]}],"aliases":["cagrilintide and semaglutide","cagrilintide-semaglutide"],"summary":"A weekly test shot that joins two drugs: cagrilintide, a copy of the hormone amylin, and the GLP-1 drug semaglutide. It is not approved.","citations":[{"n":1,"url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","tier":"primary","type":"regulatory","title":"FDA: concerns with unapproved GLP-1 drugs used for weight loss, updated 1 October 2026"},{"n":2,"url":"https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026","tier":"primary","type":"regulatory","title":"FDA: novel drug approvals for 2026, current to 20 October 2026"},{"n":3,"url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","tier":"primary","type":"regulatory","title":"FDA: bulk drug substances used in compounding under section 503A"},{"n":4,"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","tier":"primary","type":"regulatory","title":"FDA: bulk drug substances that may present significant safety risks (Category 2)"},{"n":5,"url":"https://www.fda.gov/media/94155/download","tier":"primary","type":"regulatory","title":"FDA: 503A bulk drug substance categories list"},{"n":6,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sciences-721805-03312026","tier":"primary","type":"regulatory","title":"FDA warning letter to an online seller of research-use cagrilintide, 31 March 2026"},{"n":7,"url":"https://clinicaltrials.gov/study/NCT05567796","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT05567796: REDEFINE 1, obesity without diabetes"},{"n":8,"url":"https://clinicaltrials.gov/study/NCT05394519","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT05394519: REDEFINE 2, obesity with type 2 diabetes"},{"n":9,"url":"https://clinicaltrials.gov/study/NCT05669755","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT05669755: REDEFINE 3, heart outcomes"},{"n":10,"url":"https://clinicaltrials.gov/study/NCT06131437","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT06131437: REDEFINE 4, against tirzepatide"},{"n":11,"url":"https://clinicaltrials.gov/study/NCT07564414","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT07564414: two strengths of CagriSema against semaglutide"},{"n":12,"url":"https://www.venable.com/insights/publications/2026/03/fdas-latest-glp-1-crackdown-what-compounders","tier":"legal-analysis","type":"legal-analysis","title":"Venable: FDA's latest GLP-1 enforcement, 13 March 2026"},{"n":13,"url":"https://pubmed.ncbi.nlm.nih.gov/40544433/","tier":"peer-reviewed","type":"rct","title":"REDEFINE 1: CagriSema in adults with overweight or obesity, 2025"},{"n":14,"url":"https://pubmed.ncbi.nlm.nih.gov/40544432/","tier":"peer-reviewed","type":"rct","title":"REDEFINE 2: CagriSema in adults with obesity and type 2 diabetes, 2025"},{"n":15,"url":"https://pubmed.ncbi.nlm.nih.gov/37364590/","tier":"peer-reviewed","type":"rct","title":"Phase 2 trial of CagriSema in type 2 diabetes, 2023"},{"n":16,"url":"https://pubmed.ncbi.nlm.nih.gov/42009015/","tier":"peer-reviewed","type":"rct","title":"REDEFINE 5: CagriSema against semaglutide alone in Japan and Taiwan, 2026"},{"n":17,"url":"https://pubmed.ncbi.nlm.nih.gov/42838477/","tier":"peer-reviewed","type":"human-trial","title":"Design and baseline of the CagriSema heart outcomes trial, REDEFINE 3, 2026"},{"n":18,"url":"https://pubmed.ncbi.nlm.nih.gov/42890523/","tier":"peer-reviewed","type":"systematic-review","title":"Review of trials of CagriSema against semaglutide alone, 2026"},{"n":19,"url":"https://www.cnbc.com/2026/02/24/healthy-returns-whats-next-for-novo-nordisks-obesity-drug-cagrisema.html","tier":"established-news","type":"reference","title":"CNBC: CagriSema after its trial against tirzepatide, 24 February 2026"},{"n":20,"url":"https://www.pharmexec.com/view/novo-nordisk-submits-nda-fda-cagrisema","tier":"established-news","type":"reference","title":"Pharmaceutical Executive: the maker asks FDA to approve CagriSema, 18 December 2025"}],"known_risks":["In a 68-week trial of adults without diabetes, about 8 in 10 people on it had stomach or gut problems. On a dummy shot, about 4 in 10 did [^13].","Those problems included nausea, vomiting, diarrhea, constipation and belly pain. Most were mild or moderate and went away [^13] [^14].","A 2026 review of five trials found skin reactions where the shot goes in. They were about three times as common as on semaglutide alone [^18].","Products sold online as cagrilintide are unapproved new drugs. FDA says shots skip some of the body's defenses, so germs or toxins in them can cause life-threatening illness [^6].","FDA says unapproved GLP-1 products sold online may be fake, may hold the wrong ingredient, or may hold too much or too little [^1]."],"short_answer":"CagriSema is investigational: it is still in clinical trials, and FDA has not approved it. It combines cagrilintide with semaglutide. Its maker has asked FDA for approval, which is not the same as approval. The evidence grade is moderate-human for weight loss. Pharmacies may not make it.","evidence_grade":"moderate-human","open_questions":["Nobody knows yet whether it prevents heart attacks, strokes or heart deaths. A trial of about 7,000 people with heart disease is still running [^9] [^17].","The longest published trials lasted 68 weeks. Nobody knows what years of use do to the body [^13] [^14] [^18].","A 2026 review could not tell if serious harms or cancers are more common than on semaglutide alone. There is too little data [^18].","Nobody knows if or when FDA will approve it. Its maker asked for approval in December 2025 [^20] [^19].","Nobody can tell what is in cagrilintide sold online. No trial has tested those products, and they are not the drug used in trials [^6]."],"section_routes":"The only legal way to get CagriSema in the US is to join a clinical trial [^1] [^11]. No approved product exists, and no pharmacy may lawfully make it [^1] [^2].\n\nOn 24 October 2026 this page checked one registry record of a CagriSema study open to new people [^11]. It compares two strengths of CagriSema with semaglutide in adults with obesity [^11]. Its US sites in five states were listed as not yet recruiting [^11]. Each trial has strict rules on who may join.","regulatory_as_of":"2026-10-24","section_channels":"No FDA page we found names CagriSema itself in a warning letter. What reaches people outside trials is cagrilintide on its own, one of the two parts [^6]. It is sold online labeled for research use [^6]. In March 2026 FDA sent a warning letter to one such seller. It said the products were unapproved new drugs, whatever the label said [^6].\n\nSome people may look for cagrilintide as a compounded drug. Federal law does not allow it in compounding [^1] [^12]. FDA does not check compounded drugs for quality before they are sold [^1].\n\nIn each case, nobody checks what is in the vial [^1]. FDA warns that unapproved GLP-1 products sold online may be fake or hold the wrong amount of drug [^1].","section_evidence":"The evidence grade is moderate-human: large trials in people show more weight loss than a dummy shot [^13] [^14]. None has yet shown fewer heart attacks, and the maker paid for them [^17]. In a 68-week trial of 3,417 adults without diabetes, weight fell by about 20%. On a dummy shot it fell by about 3% [^13]. In a 68-week trial of 1,206 adults with type 2 diabetes, weight fell by about 14%, against about 3% on a dummy shot [^14].\n\nSome trials compared it with semaglutide alone. In a 32-week US trial of 92 adults with type 2 diabetes, weight fell by about 16%. On semaglutide alone it fell by 5% [^15]. HbA1c, a blood test of average blood sugar, fell by about the same amount in both groups [^15]. In a 68-week trial of 331 adults in Japan and Taiwan, weight fell by about 18%, against 12% on semaglutide alone [^16]. A 2026 review of five trials found about 7 points more weight loss than semaglutide alone. It found no added effect on blood sugar [^18].\n\nIn a trial against tirzepatide, another approved drug, CagriSema led to slightly less weight loss after 84 weeks [^10] [^19]. A heart trial of 7,076 adults with heart disease has not reported results yet [^9] [^17].\n\nThese trials tested the maker's own combined drug. They tell us nothing about cagrilintide sold online, which is a different product [^6].","regulatory_status":"investigational","section_what_it_is":"CagriSema is an experimental drug given as a weekly shot under the skin [^17]. It joins two drugs in one shot [^17]. Cagrilintide is a long-acting copy of the hormone amylin [^15] [^17]. Semaglutide is a GLP-1 drug [^15]. Together they lead to weight loss [^15].\n\nSemaglutide on its own is an approved drug, and it has its own page on this site. Cagrilintide is not part of any approved drug [^1]. One drug company makes CagriSema and has paid for its large trials [^13] [^14] [^17]. It is not sold in any pharmacy, and FDA has not approved it for any condition [^1] [^2].","section_is_it_legal":"CagriSema is investigational: it is being tested in clinical trials, and FDA has not approved it for any use [^1] [^2]. Its maker has asked FDA to approve it, and that request is not an approval [^20]. It also does not let pharmacies make it. Checked 24 October 2026.\n\nFDA keeps a list of new drugs it approved in 2026. That list, current to 20 October 2026, does not include CagriSema or cagrilintide [^2]. The maker filed its request in December 2025 [^20]. A news report in February 2026 said a decision was expected late in 2026 [^19].\n\nIt is being studied for weight loss in people with obesity, with or without type 2 diabetes, and in people with heart disease [^7] [^8] [^9]. Online, cagrilintide on its own is sold for weight loss, labeled for research only [^6].\n\nUnder federal law, pharmacies may not use cagrilintide to make drugs [^1] [^12]. It is not part of any approved drug [^1]. It is also not on either of FDA's lists of raw ingredients for pharmacies [^4] [^5]. A pharmacy may use a raw ingredient on only three bases [^3]. It meets an official quality standard, it is part of an approved drug, or it is on FDA's 503A bulks list [^3]. A research-use label does not change this. FDA treats such a product as an unapproved new drug when its seller shows it is meant for people [^6].","unofficial_channels":[{"type":"research-use-seller","what_it_is":"Cagrilintide on its own, one of the two parts of CagriSema, sold online labeled for research use.","enforcement":[{"date":"2026-03-31","text":"FDA warning letter to an online seller of research-use cagrilintide.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sciences-721805-03312026"}],"legal_position":{"text":"FDA treats these as unapproved new drugs when the seller's site shows they are meant for people, whatever the label says.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sciences-721805-03312026"},"documented_risks":[{"text":"FDA warns that injected products skip some of the body's defenses, so toxins or germs in them can cause life-threatening illness.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sciences-721805-03312026"},{"text":"FDA says cagrilintide has not been found to meet its standards for any condition and is not part of any approved drug.","source_url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss"}]},{"type":"compounding-outside-the-rules","what_it_is":"Cagrilintide offered as a compounded drug, mixed by a pharmacy from raw ingredient.","legal_position":{"text":"Cagrilintide cannot be used in compounding under federal law. It is not part of any approved drug.","source_url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss"},"documented_risks":[{"text":"FDA does not check compounded drugs for quality, or for whether they help, before they are sold.","source_url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss"}]}]},"provenance":{"name":{"fact_id":"9a2abfe2-4276-4ff6-82ac-cfc3e09c74a8","source_url":"https://pubmed.ncbi.nlm.nih.gov/42838477/","source_type":"peer-reviewed","captured_at":"2026-10-25T01:47:39.334Z","checked_at":"2026-10-25T06:27:05.650Z","confidence":1,"stale":false},"class":{"fact_id":"05ad3a8d-bbe8-42c3-945f-8183bbf5a321","source_url":"https://pubmed.ncbi.nlm.nih.gov/42838477/","source_type":"peer-reviewed","captured_at":"2026-10-25T01:47:39.334Z","checked_at":"2026-10-25T06:27:05.643Z","confidence":1,"stale":false},"access":{"fact_id":"d68d4420-7896-449f-9bdf-e4d31b0f95f3","source_url":"https://clinicaltrials.gov/study/NCT07564414","source_type":"primary","captured_at":"2026-10-25T01:47:35.511Z","checked_at":"2026-10-25T06:27:05.606Z","confidence":1,"stale":false},"trials":{"fact_id":"1ed3e8f5-f59f-4850-8dc3-9c1461ecbefd","source_url":"https://clinicaltrials.gov/api/v2/studies?query.intr=CagriSema+OR+cagrilintide+semaglutide&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState","source_type":"primary","captured_at":"2026-10-25T18:03:21.544Z","checked_at":"2026-10-25T18:03:21.544Z","confidence":1,"stale":false},"aliases":{"fact_id":"a2410c2e-0a7b-46a5-8a9a-2acac1e995d1","source_url":"https://pubmed.ncbi.nlm.nih.gov/40544432/","source_type":"peer-reviewed","captured_at":"2026-10-25T01:47:37.028Z","checked_at":"2026-10-25T06:27:05.642Z","confidence":1,"stale":false},"summary":{"fact_id":"2bbff6ad-b246-4741-a23b-91242acea170","source_url":"https://www.pharmexec.com/view/novo-nordisk-submits-nda-fda-cagrisema","source_type":"established-news","captured_at":"2026-10-25T01:45:53.097Z","checked_at":"2026-10-25T06:27:05.635Z","confidence":1,"stale":false},"citations":{"fact_id":"c533945f-3316-4d75-947f-8bb96166c888","source_url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","source_type":"primary","captured_at":"2026-10-24T04:24:23.450Z","checked_at":"2026-10-25T06:27:05.656Z","confidence":1,"stale":false},"known_risks":{"fact_id":"593939ce-ae0a-4e25-89f3-4ac435f5a547","source_url":"https://pubmed.ncbi.nlm.nih.gov/40544433/","source_type":"peer-reviewed","captured_at":"2026-10-25T01:47:36.270Z","checked_at":"2026-10-25T06:27:05.651Z","confidence":1,"stale":false},"short_answer":{"fact_id":"c1fb24e2-7e6c-4764-a8de-ff782147f53c","source_url":"https://peptideindex.ai/methodology#short-answer","source_type":"reference","captured_at":"2026-10-25T00:14:44.418Z","checked_at":"2026-10-25T06:27:05.645Z","confidence":1,"stale":false,"label":"our assessment"},"evidence_grade":{"fact_id":"09af2193-1618-4980-a75f-edc764063de6","source_url":"https://peptideindex.ai/methodology#evidence-grade","source_type":"reference","captured_at":"2026-10-25T00:14:45.193Z","checked_at":"2026-10-25T06:27:05.648Z","confidence":1,"stale":false,"label":"our 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