CagriSema — Novo Nordisk's once-weekly combination of cagrilintide (a long-acting amylin analog) and semaglutide (a GLP-1 receptor agonist) — is one of the most closely watched unapproved drugs in the obesity space. Its New Drug Application has been on file with the FDA since December 18, 2025, and Novo Nordisk has said in a securities filing that a decision is "anticipated by late 2026." That is the entire public timing record: the FDA has not announced a specific PDUFA goal date, and any page that prints one is guessing.
This tracker exists because the existing coverage cannot hold the answer. News articles are point-in-time by design — each one captures the day it was written, then goes stale while the review continues. Drug-database status pages say "investigational" and rarely explain what is actually pending or what the next milestone is. What the story needs, and what this page is, is a maintained status tracker: a dated timeline of everything that has happened, a clear statement of what is still unknown, and a maintenance commitment that the page updates when Novo Nordisk or the FDA publish something new.
The page is educational only. CagriSema is investigational in the United States, this is not medical advice, and nothing here tells any individual to seek, use, or wait for any medication.
Reclassification table
Last updated: October 16, 2026. This YMYL tracker is generated from published PeptaHub peptide entries marked reclassification-pending.
| BPC-157 | Reclassification pending | Awaiting formal FDA or compounding-policy update | BPC-157 cannot legally be compounded in the US today. It is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. The Pharmacy Compounding Advisory Committee took up BPC-157 on July 23, 2026 (docket FDA-2025-N-6895); FDA staff briefing documents recommended against adding it to the Bulks List, but the committee voted in favor of adding BPC-157 — one of six substances (out of seven on the docket) it recommended for the Bulks List. PCAC is advisory: its vote is a recommendation rather than a binding decision, the FDA's final decision remains pending, and formal rulemaking afterward typically takes 12 to 24 months. Many US suppliers paused sales in 2025-2026 pending regulatory clarity. Verify current federal and state rules before relying on access claims. |
| Dihexa | Reclassification pending | Awaiting formal FDA or compounding-policy update | Dihexa cannot legally be compounded in the US today. It is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. Dihexa, which the FDA lists as dihexa acetate, was not among the seven peptides heard on July 23-24, 2026; the FDA has stated the Pharmacy Compounding Advisory Committee will reconvene before the end of February 2027 to consider it alongside GHK-Cu, Melanotan II, LL-37, and PEG-MGF. PCAC is advisory and formal rulemaking afterward typically takes 12 to 24 months. Dihexa is not FDA-approved for any indication, is otherwise sold as a research chemical, and is not scheduled. Verify current federal and state rules before relying on access claims. |
| DSIP | Reclassification pending | Awaiting formal FDA or compounding-policy update | DSIP cannot legally be compounded in the US today. It is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. The Pharmacy Compounding Advisory Committee took up DSIP, which the FDA lists under the name emideltide, on July 24, 2026 (docket FDA-2025-N-6895); FDA staff briefing documents recommended against adding it to the Bulks List. PCAC is advisory and formal rulemaking afterward typically takes 12 to 24 months. DSIP is not FDA-approved for any indication, is otherwise sold as a research peptide, and is not scheduled. Verify current federal and state rules before relying on access claims. |
| Epithalon | Reclassification pending | Awaiting formal FDA or compounding-policy update | Epithalon cannot legally be compounded in the US today. It is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. The Pharmacy Compounding Advisory Committee took up the substance, which the FDA lists as Epitalon, on July 24, 2026 (docket FDA-2025-N-6895); FDA staff briefing documents recommended against adding it to the Bulks List, citing inconsistent naming conventions among other concerns. PCAC is advisory and formal rulemaking afterward typically takes 12 to 24 months. Epithalamin (the natural extract) is approved in Russia as a pharmaceutical; the synthetic version is not FDA-approved and is otherwise sold as a research chemical internationally. Verify current federal and state rules before relying on access claims. |
| GHK-Cu | Reclassification pending | Awaiting formal FDA or compounding-policy update | This status describes injectable GHK-Cu, which cannot legally be compounded in the US today. Topical GHK-Cu is a separate matter: it is a long-established cosmetic ingredient (INCI: copper tripeptide-1), sold without restriction and regulated under cosmetic rather than drug authority, and nothing below affects it. On the injectable bulk drug substance: GHK-Cu is one of 12 peptides covered by the FDA's April 15, 2026 action on the interim 503A bulk drug substances list, effective within seven calendar days, taken because the original nominators withdrew their nominations. Note a detail specific to GHK-Cu — legal commentary indicates it was removed from Category 1 rather than Category 2, meaning it lost the enforcement discretion it previously had, while the other 11 were removed from Category 2. Either way the outcome is the same: the substance is not on the Section 503A Bulks List, enforcement discretion no longer applies, and it is not eligible for compounding. GHK-Cu was not among the seven peptides heard on July 23-24, 2026 (docket FDA-2025-N-6895); the FDA has stated the Pharmacy Compounding Advisory Committee will reconvene before the end of February 2027 to consider it alongside Melanotan II, LL-37, dihexa acetate, and PEG-MGF. PCAC recommendations are advisory only, and formal rulemaking afterward typically takes 12 to 24 months, so injectable compounding status is unlikely to change quickly. Injectable GHK-Cu sold as a research chemical is not FDA-approved for any indication. Verify current federal and state rules before relying on access claims. |
| KPV | Reclassification pending | Awaiting formal FDA or compounding-policy update | KPV cannot legally be compounded in the US today. It is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. The Pharmacy Compounding Advisory Committee took up KPV-related bulk drug substances (KPV free base and KPV acetate) on July 23, 2026 (docket FDA-2025-N-6895); FDA staff briefing documents recommended against adding them to the Bulks List. PCAC is advisory and formal rulemaking afterward typically takes 12 to 24 months. KPV is not FDA-approved for any indication and is otherwise sold as a research peptide. Verify current federal and state rules before relying on access claims. |
| LL-37 | Reclassification pending | Awaiting formal FDA or compounding-policy update | LL-37 cannot legally be compounded in the US today. It is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. LL-37, which the FDA lists as cathelicidin, was not among the seven peptides heard on July 23-24, 2026; the FDA has stated the Pharmacy Compounding Advisory Committee will reconvene before the end of February 2027 to consider it alongside GHK-Cu, dihexa acetate, Melanotan II, and PEG-MGF. PCAC is advisory and formal rulemaking afterward typically takes 12 to 24 months, so compounding status is unlikely to change quickly. LL-37 is not FDA-approved for any indication and is otherwise sold as a research peptide; it remains in clinical development for wound healing and infection applications. Verify current federal and state rules before relying on access claims. |
| Melanotan II | Reclassification pending | Awaiting formal FDA or compounding-policy update | Melanotan II cannot legally be compounded in the US today, is not FDA-approved for any indication, and is not legally marketed as a drug or cosmetic; it is sold as a research chemical outside any verified supply chain. The FDA, the Australian TGA, and the UK MHRA have all issued warnings against cosmetic use. It is not a scheduled controlled substance in most jurisdictions. On compounding: Melanotan II is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. Melanotan II was not among the seven peptides heard on July 23-24, 2026 (docket FDA-2025-N-6895); the FDA has stated the Pharmacy Compounding Advisory Committee will reconvene before the end of February 2027 to consider it alongside GHK-Cu, LL-37, dihexa acetate, and PEG-MGF. Industry commentary has generally expected Melanotan II to remain restricted. PCAC recommendations are advisory only, and formal rulemaking afterward typically takes 12 to 24 months. Two related melanocortin agonists are FDA-approved and legally available by prescription — bremelanotide (Vyleesi) and afamelanotide (SCENESSE) — but neither is Melanotan II. Verify current federal and state rules before relying on access claims. |
| MOTS-c | Reclassification pending | Awaiting formal FDA or compounding-policy update | MOTS-c cannot legally be compounded in the US today, and it is not FDA-approved or approved as a pharmaceutical or supplement ingredient in any country. It is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. The Pharmacy Compounding Advisory Committee took up MOTS-c-related bulk drug substances (MOTS-c free base and MOTS-c acetate) on July 23, 2026 (docket FDA-2025-N-6895), alongside BPC-157, TB-500, and KPV, with emideltide (DSIP), Semax, and Epitalon heard on July 24. FDA staff briefing documents recommended against inclusion for all seven, concluding that none satisfied the criteria in 21 CFR 216.23(c) and citing inadequate substance characterization, inconsistent naming, missing quality data, insufficient human clinical evidence, and immunogenicity safety flags. PCAC is advisory: its vote is a recommendation rather than a binding decision, FDA must still decide whether to accept it, and formal rulemaking typically takes a further 12 to 24 months. Verify the current docket record and federal and state rules before relying on access claims. |
| PEG-MGF | Reclassification pending | Awaiting formal FDA or compounding-policy update | PEG-MGF cannot legally be compounded in the US today. It is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. PEG-MGF, which the FDA lists as pegylated mechano growth factor, was not among the seven peptides heard on July 23-24, 2026; the FDA has stated the Pharmacy Compounding Advisory Committee will reconvene before the end of February 2027 to consider it alongside GHK-Cu, Melanotan II, LL-37, and dihexa acetate. Industry commentary has generally expected PEG-MGF to remain restricted. PCAC is advisory and formal rulemaking afterward typically takes 12 to 24 months. PEG-MGF is not FDA-approved, is otherwise sold by research peptide suppliers as a laboratory compound, and is prohibited by WADA in competitive sport. Verify current federal and state rules before relying on access claims. |
| Semax | Reclassification pending | Awaiting formal FDA or compounding-policy update | Semax cannot legally be compounded in the US today. It is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. The Pharmacy Compounding Advisory Committee took up Semax on July 24, 2026 (docket FDA-2025-N-6895); FDA staff briefing documents recommended against adding it to the Bulks List. PCAC is advisory and formal rulemaking afterward typically takes 12 to 24 months. Semax is approved as a prescription drug in Russia and Ukraine but is not FDA-approved in the US, where it is otherwise sold as a research peptide and is not scheduled. Verify current federal and state rules before relying on access claims. |
| TB-500 | Reclassification pending | Awaiting formal FDA or compounding-policy update | TB-500 cannot legally be compounded in the US today. It is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. The Pharmacy Compounding Advisory Committee took up TB-500-related bulk drug substances (TB-500 free base and TB-500 acetate) on July 23, 2026 (docket FDA-2025-N-6895); FDA staff briefing documents recommended against adding them to the Bulks List, citing inconsistent naming conventions among other concerns. PCAC is advisory and formal rulemaking afterward typically takes 12 to 24 months. Previously sold as a research chemical, and widely used in veterinary medicine. Verify current federal and state rules before relying on access claims. |
What CagriSema is, and why it has a tracker
CagriSema is a fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg, given as a once-weekly subcutaneous injection, developed by Novo Nordisk for weight management (the REDEFINE program) and type 2 diabetes (the REIMAGINE program). The two components work on different satiety systems: cagrilintide is a long-acting analog of the hormone amylin, and semaglutide is a GLP-1 receptor agonist already marketed by Novo Nordisk. It is investigational — not approved in the US for weight loss — and its regulatory fate is one of the few genuinely dated catalysts left in the obesity-drug story this year.
That is why a tracker, not another article. A news piece answers "what happened today"; a tracker answers "what is the current state of the whole review, and what happens next." The sections below give the timeline date by date, the specific things worth watching, and an explanation of why no responsible source can print an exact FDA decision date for this application yet.
The regulatory timeline, date by date
December 2024: Novo Nordisk announced headline results from REDEFINE-1, a phase 3 trial in 3,417 adults with overweight or obesity. CagriSema produced a 22.7% mean weight reduction at 68 weeks versus 2.3% on placebo under the trial product estimand (the estimate if all participants had adhered to treatment); under the treatment policy estimand, which counts everyone regardless of adherence, the figures were 20.4% versus 3.0%. The results were subsequently published in the New England Journal of Medicine in 2025.
March 2025: Novo Nordisk announced REDEFINE-2 results in adults with overweight or obesity and type 2 diabetes, reporting a 15.7% mean weight reduction for CagriSema if participants adhered to treatment (13.7% regardless of adherence), versus about 3% on placebo.
December 18, 2025: Novo Nordisk filed the CagriSema New Drug Application (NDA) with the US FDA for weight management. The company later confirmed on the record that the filing was "based on the REDEFINE 1 and REDEFINE 2 pivotal trials."
February 2, 2026: Novo Nordisk announced headline results from REIMAGINE 2, a separate 68-week phase 3 trial in 2,728 adults with type 2 diabetes. CagriSema 2.4 mg beat semaglutide 2.4 mg head-to-head on both endpoints: weight loss of 14.2% versus 10.2% (efficacy estimand) and HbA1c reduction of 1.91 versus 1.76 percentage points. REIMAGINE 2 is not the basis of the pending NDA — Novo said it will approach regulators about a type 2 diabetes pathway separately, after its REIMAGINE 1 and REDEFINE 3 trials.
February 23, 2026: In an SEC filing, Novo Nordisk stated that the FDA decision on CagriSema is "anticipated by late 2026." No specific PDUFA date was given.
As of October 16, 2026 (this tracker's current update): the NDA remains under review. The FDA has not announced a PDUFA goal date for CagriSema, no approval decision has been made public, and Novo Nordisk's "anticipated by late 2026" SEC language remains the only on-record timing signal.
What we're watching
The approval decision itself: an approval, a complete response letter (which typically lists deficiencies and required next steps), or a request for more information. Any of the three is a story, and this page will record which one happened and what it said.
The label, if approved: what indication wording the FDA accepts, which patient population the label covers, and what the approved dosing and titration schedule looks like. Label scope is where the FDA's judgment shows up most concretely, and it is routinely narrower or different from what a sponsor requested.
The launch picture: availability timing, the pen device format, and how the product is actually supplied — the operational details that turn an approval into something a patient can eventually be prescribed. And one level up: whether the FDA holds an advisory committee meeting or publishes briefing documents during the review, which would surface the agency's own reading of the REDEFINE data.
A second track to keep separate: a potential future type 2 diabetes filing. The pending NDA is a weight-management application built on REDEFINE 1 and 2; the REIMAGINE program (including the February 2026 REIMAGINE 2 readout, where CagriSema beat semaglutide 2.4 mg head-to-head in adults with type 2 diabetes) supports a separate, later regulatory pathway that Novo has said it will discuss with authorities.
Why there is no PDUFA date on this page
Under the Prescription Drug User Fee Act (PDUFA), the FDA sets a goal date for acting on most new drug applications. A goal date is a review-clock target, not a guarantee of approval. And importantly for readers trying to plan around a decision: they are not always made public. Sponsors sometimes disclose them in press releases or securities filings, and sometimes neither the company nor the agency publishes one at all.
CagriSema is currently in that second category. No PDUFA goal date for CagriSema appears in FDA materials, and Novo Nordisk has not printed one — its February 23, 2026 SEC filing says only that the decision is "anticipated by late 2026." That undated sentence is the only timing commitment on the record, so it is the only one this tracker prints. Expecting a decision in Q4 2026 is a reasonable reading of "by late 2026"; predicting a specific day is not, and any site that shows you a calendar date for this decision is constructing it, not reporting it.
Tracker maintenance policy
PeptaHub updates this page when the underlying facts change: when Novo Nordisk or the FDA publishes anything material about the CagriSema application — an approval, a complete response letter, a disclosed goal date, an advisory committee announcement, a label — or when Novo's own public guidance on timing changes. The "last updated" date at the top moves with every material revision, and the timeline section is append-only: past entries stay as written so readers can see the record, not just the latest headline.
If CagriSema is approved or the application is otherwise resolved, this page will say so at the top, record the decision in the timeline, and shift its focus to label scope and launch. If you need the primary record itself, the two sources to check are Novo Nordisk's investor-relations announcements and the FDA's own approval databases — those, not this page, are authoritative.
Editorial caution
This is an educational status tracker, not medical, legal, or investment advice. CagriSema is an investigational drug; it is not FDA-approved, and nothing on this page should be read as encouragement to seek it, use it, or wait for it. Whether any medication is appropriate for a given person is a decision for a licensed clinician with access to that person's full medical record.
The topic is YMYL by nature — it touches a regulated health product mid-review, where hopes and money both run high. PeptaHub's role here is narrow and deliberate: to keep an accurate, dated, citeable public record of where the application stands, so readers do not have to rely on stale news or guessed dates.
Cite this tracker
PeptaHub Editorial Team. CagriSema FDA Approval Tracker. PeptaHub. Updated October 16, 2026. Primary sources to check: Novo Nordisk investor relations (novonordisk.com) and FDA (fda.gov). https://peptahub.com/guides/cagrisema-fda-approval-tracker
Frequently asked questions
No specific date is on the record. The FDA has not announced a PDUFA goal date for CagriSema, and Novo Nordisk's February 23, 2026 SEC filing says only that the decision is "anticipated by late 2026" — undated. A Q4 2026 expectation is a reasonable reading of that language, but any page printing an exact decision date for CagriSema is inventing it.
No. As of this tracker's October 16, 2026 update, CagriSema remains investigational in the United States. The NDA filed on December 18, 2025 is under review, and no approval decision has been announced.
In REDEFINE-1 (3,417 adults with overweight or obesity, results announced December 2024 and published in the New England Journal of Medicine in 2025), CagriSema produced a 22.7% mean weight reduction at 68 weeks versus 2.3% on placebo if participants adhered to treatment (20.4% versus 3.0% regardless of adherence). In REDEFINE-2, in adults with overweight or obesity and type 2 diabetes, Novo Nordisk reported a 15.7% mean weight reduction if participants adhered to treatment (13.7% regardless of adherence) versus about 3% on placebo, in its March 2025 announcement. Separately, in the February 2026 REIMAGINE 2 trial in adults with type 2 diabetes, CagriSema beat semaglutide 2.4 mg head-to-head with 14.2% versus 10.2% weight loss. These are trial-arm averages, not predictions for any individual.
A PDUFA goal date is the target the FDA sets for finishing its review of a new drug application. It is a review-clock deadline, not an approval guarantee, and it is not always published by either the FDA or the sponsor. For CagriSema, neither has published one; Novo's SEC filing language ("anticipated by late 2026") is the only official timing signal that exists.
Mechanistically, CagriSema pairs amylin signaling (cagrilintide) with GLP-1 signaling (semaglutide) in one weekly injection, while [tirzepatide](/peptides/tirzepatide) (Zepbound/Mounjaro) is a single molecule activating both GIP and GLP-1 receptors and is already FDA-approved. PeptaHub maintains detailed head-to-head pages — CagriSema vs tirzepatide and CagriSema vs semaglutide — with the trial-by-trial data. This tracker stays on the narrower question: where the FDA application stands.
Whenever the facts move: an FDA action on the application, a Novo Nordisk announcement or SEC filing that changes the timing picture, or an approval and label. The last-updated date tracks every material revision, and the timeline is append-only so the record remains visible.