CagriSema

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].

Semaglutide 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]}.

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.

FDA 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].

It 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].

Under 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].

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].

Some 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].

In 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]}.

These trials tested the maker's own combined drug. They tell us nothing about cagrilintide sold online, which is a different product ^[6].

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]}.

On 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.

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].

Some 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].

In 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].