Dulaglutide
Also sold as: Trulicity, LY2189265
Dulaglutide is the active ingredient in Trulicity, a biological product licensed to Eli Lilly and Company under BLA 125469 and approved by FDA on 18 September 2014 under section 351(a) of the Public Health Service Act. The current FDA-approved labeling carries exactly two indications — improving glycemic control as an adjunct to diet and exercise in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus, and reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors — with no weight-management indication and a boxed warning for risk of thyroid C-cell tumors. Dulaglutide is also not a synthetic peptide: FDA's labeling describes a fusion protein of two identical disulfide-linked chains joining a GLP-1 analog sequence to the Fc portion of a modified human IgG4 heavy chain, of approximately 63 kilodaltons, produced using Chinese hamster ovary cell culture — and FDA has stated that biological products approved in a BLA under section 351 of the PHS Act 'are not eligible for the exemptions in section 503A of the FD&C Act' and 'will not be considered for the 503A bulks list', so dulaglutide sits outside the 503A compounding process rather than anywhere inside it.
Which molecule this is. Dulaglutide is a GLP-1 receptor agonist, but it is not a peptide and it is not a drug in the regulatory sense — it is a BIOLOGICAL PRODUCT. FDA's approved labeling describes the molecule as 'a fusion protein that consists of 2 identical, disulfide-linked chains, each containing an N-terminal GLP-1 analog sequence covalently linked to the Fc portion of a modified human immunoglobulin G4 (IgG4) heavy chain by a small peptide linker', with an overall molecular weight of approximately 63 kilodaltons, 'produced using mammalian cell (Chinese hamster ovary) culture'. Two consequences follow, and both are structural rather than rhetorical. It is licensed under section 351(a) of the Public Health Service Act rather than approved under section 505 of the FD&C Act, which places it outside the 503A compounding exemptions entirely. And it cannot be made by solid-phase peptide synthesis: a 63 kDa glycoprotein grown in CHO cell culture is not a molecule a research-chemical supplier can produce the way it produces a 15-residue peptide. That is the most likely reason dulaglutide is largely absent from the grey market that sells every other GLP-1.
FDA status
FDA has approved this as a drug. Approval is always for a specific indication and a specific population — check which one, because it is frequently not the use it is marketed for.
FDA-approved, and the approval is a LICENSURE rather than a new drug approval: the letter refers to a Biologics License Application 'submitted under section 351(a) of the Public Health Service Act' and issues Trulicity under U.S. License No. 1891. Cross-checked against Drugs@FDA on 2026-08-02 via openFDA: application BLA125469, sponsor ELI LILLY AND CO, original submission approved 20140918 as a Type 1 New Molecular Entity, four TRULICITY products, every one with marketing status 'Prescription'. Read the quoted indication as the 2014 one, not the current one — it has been widened twice since, by the supplements recorded under fdaFindings, and the current verbatim indications are under fdaApproval below.
“We have approved your BLA for Trulicity (dulaglutide) effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce, Trulicity, under your existing department of Health and Human Services U.S. License No. 1891. Trulicity is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.”Checked against the source on .
Evidence
Efficacy established by adequate, well-controlled trials in humans.
Administration check RUN, not assumed. REWIND (NCT01394952) was opened and read on 2026-08-02: study type INTERVENTIONAL, phase 3, intervention type DRUG, name 'Dulaglutide' (other name LY2189265), description 'Administered subcutaneously', versus a subcutaneously administered placebo; randomised, double-masked, parallel assignment; enrolment 9,901 ACTUAL; lead sponsor Eli Lilly and Company; status COMPLETED with primary completion 2018-08-21 ACTUAL and results first posted 2019-10-08 ACTUAL. Dulaglutide was ADMINISTERED to humans — it was not measured as an endogenous biomarker, which is the trap that reduces MOTS-c and TB-500 from an apparent five human RCTs to an actual zero. Corroborated inside the regulatory record rather than only in the registry: FDA's own supplement approval letter names 'Study GBDJ (REWIND), a Phase 3 cardiovascular outcomes trial' as the basis for the cardiovascular indication, and section 14.5 of the approved labeling describes the same trial with the same registration number and the same enrolment. A second administration check was run on AWARD-PEDS (NCT02963766), the paediatric trial: INTERVENTIONAL, phase 3, intervention type DRUG 'Dulaglutide', 'Administered SC', 154 participants ACTUAL, Eli Lilly and Company, COMPLETED, results posted 2022-07-01. SCOPE — this tier attaches to the two approved indications and to the approved Trulicity products, and to nothing else. The REWIND result is a cardiovascular outcome in adults with type 2 diabetes who had established cardiovascular disease or multiple cardiovascular risk factors. It is not evidence for weight management, for use without type 2 diabetes, or for any product other than the licensed one.
What FDA actually approved
- Application
- BLA 125469 (U.S. License No. 1891) — Trulicity
- Approved indication
- TRULICITY is indicated: As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.
This is the COMPLETE indications section of the current labeling, not an excerpt — section 1 contains these two bullets and nothing else. Both are gated on 'type 2 diabetes mellitus', and there is no weight-management indication, no obesity indication, and no indication that reaches a patient without type 2 diabetes. That gap is the one worth reading, because 'GLP-1' now reads as 'weight-loss drug' and this GLP-1 has never been approved for weight management. Note also that the cardiovascular indication is not a general cardiovascular claim: it is confined to adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors. `discontinued` is false on the record as read on 2026-08-02: Drugs@FDA lists all four TRULICITY presentations with marketing status 'Prescription', and FDA approved a labeling supplement to this BLA on 2026-03-12. Widely circulated web content stating that Trulicity was discontinued in October 2024 is contradicted by FDA's own record. SUPPLY IS A SEPARATE QUESTION and this record does not answer it: marketing status in Drugs@FDA is not a statement about availability at a pharmacy, and we did not verify shortage status.
“TRULICITY ® is indicated: • As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. • To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.”Checked against the source on .
What FDA found
FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.
FDA has stated that biological products subject to approval in a biologics license application under section 351 of the Public Health Service Act are not eligible for the exemptions in section 503A of the FD&C Act, and will not be considered for the 503A bulks list. Dulaglutide is approved in such an application — BLA 125469, submitted under section 351(a) of the PHS Act.
The single most useful sentence on this record, and the reason this compound has no 503A status field at all. FDA is not saying dulaglutide was evaluated for compounding and rejected; it is saying molecules in its regulatory class are outside that process as a matter of eligibility. So the correct answer to 'what 503A category is dulaglutide in' is that the question does not apply — which is different from 'category 1', different from 'withdrawn', and different from the never-nominated silence that covers an approved small-molecule drug. SCOPE, because it is narrower than it looks: this quote is from FDA's 503A interim policy guidance and speaks to section 503A. FDA has made a materially similar statement about the 503B bulks list elsewhere; that document is not cited here and no 503B claim is made on this record. This is also not a statement that no lawful handling of the licensed product can occur — FDA has separate guidance on mixing, diluting or repackaging biological products outside the scope of an approved BLA, which this footnote itself cross-references.
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act — Guidance for Industry — FDA, 7 January 2025“Biological products subject to approval in a biologics license application (BLA) under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262) are not eligible for the exemptions in section 503A of the FD&C Act (21 U.S.C. 353a). Biological products subject to approval in a BLA under section 351 of the PHS Act will not be considered for the 503A bulks list.”
Checked against the source on .The FDA-approved labeling describes dulaglutide as a fusion protein of two identical, disulfide-linked chains, each containing an N-terminal GLP-1 analog sequence covalently linked to the Fc portion of a modified human immunoglobulin G4 heavy chain by a small peptide linker, with an overall molecular weight of approximately 63 kilodaltons, produced using mammalian cell (Chinese hamster ovary) culture.
Recorded verbatim because 'peptide' is doing the work in every list that groups this molecule with BPC-157 and semaglutide. FDA's own description is of an antibody-Fc fusion protein grown in cell culture, roughly twenty times the mass of semaglutide. The practical consequence is a manufacturing one and it explains an absence this site otherwise could not: a research-chemical supplier can synthesise a short peptide, and cannot culture a CHO cell line. Dulaglutide is correspondingly missing from FDA's warning letters about unapproved GLP-1 products, which name semaglutide, tirzepatide and retatrutide. We searched for and did not find any FDA warning letter naming dulaglutide as a research-labelled product; an absence found by searching is weaker than a document, and it is recorded here as an absence, not as a finding.
TRULICITY (dulaglutide) injection — Highlights of Prescribing Information — FDA, 12 March 2026“Dulaglutide is a human GLP-1 receptor agonist. The molecule is a fusion protein that consists of 2 identical, disulfide-linked chains, each containing an N-terminal GLP-1 analog sequence covalently linked to the Fc portion of a modified human immunoglobulin G4 (IgG4) heavy chain by a small peptide linker and is produced using mammalian cell (Chinese hamster ovary) culture. … The overall molecular weight of dulaglutide is approximately 63 kilodaltons.”
Checked against the source on .Dulaglutide appears in none of Categories 1, 2 or 3 of FDA's list of bulk drug substances nominated for use in compounding under section 503A, updated 2026-05-14.
Verified by fetching the PDF with a browser user-agent and text-extracting it locally on 2026-08-02: zero occurrences of 'dulaglutide', and zero of 'glutide' in any form. This absence must NOT be read the way BPC-157's absence is read. BPC-157 was nominated, sat in Category 2, and left when the nominators withdrew. Dulaglutide was never in this document because, per the FDA guidance recorded above, a BLA biological product is not eligible for the 503A exemptions and will not be considered for this list. Absence here is neither permission, nor a safety finding, nor a withdrawal.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on .FDA approved the cardiovascular indication on 2020-02-21, in a prior approval supplemental biologics license application, on the basis of Study GBDJ (REWIND).
Recorded because it ties the evidence tier on this record to a specific FDA action on a specific trial, rather than to a registry entry we found ourselves. FDA's letter also characterises this supplement as a 'FULFILLMENT OF POSTMARKETING REQUIREMENT' — the cardiovascular outcomes trial was an obligation attached to the original 2014 licensure, not a voluntary label expansion.
BLA 125469/S-033 Supplement Approval — Trulicity (dulaglutide) injection — FDA, 21 February 2020“This Prior Approval supplemental biologics application provides for the addition of efficacy and safety information to the Prescribing Information, including a new indication for reduction of major adverse cardiovascular events in adults with type 2 diabetes mellitus, based on the clinical data from Study GBDJ (REWIND), a Phase 3 cardiovascular outcomes trial.”
Checked against the source on .FDA extended the glycemic-control indication to pediatric patients 10 years of age and older with type 2 diabetes mellitus on 2022-11-17, in a priority-reviewed prior approval supplemental biologics license application.
Note the precise scope: the paediatric extension reaches the GLYCEMIC indication only. The cardiovascular indication remains adults-only in the current labeling. Drugs@FDA records this supplement (SUPPL 51) with review priority PRIORITY, the only priority-reviewed submission in this application's history.
BLA 125469/S-051 Supplement Approval — Trulicity (dulaglutide) injection — FDA, 17 November 2022“This Prior Approval sBLA provides for expansion of the indication for Trulicity, as an adjunct to diet and exercise to improve glycemic control, to pediatric patients 10 years of age and older with type 2 diabetes mellitus.”
Checked against the source on .Drugs@FDA lists four TRULICITY products under BLA 125469 — 0.75 mg/0.5 mL, 1.5 mg/0.5 mL, 3 mg/0.5 mL and 4.5 mg/0.5 mL injectable solutions, sponsor ELI LILLY AND CO — each with marketing status 'Prescription'. The most recent approved submission on the application is a labeling supplement approved 2026-03-12.
Recorded to answer a question the secondary corpus answers wrongly. Multiple widely syndicated pages state that Eli Lilly discontinued Trulicity in October 2024 and that it is no longer manufactured or distributed. FDA's own record does not support that as of 2026-08-02: no product on the application carries a discontinued marketing status, and FDA approved a labeling supplement to it in March 2026. What this finding does NOT establish is availability — Drugs@FDA marketing status is a regulatory field, not a supply report, and shortage status was not checked for this record. The strengths above are product identification, which is what is in the pen; this site does not publish what to do with it.
Drugs@FDA record for BLA 125469 (openFDA drug/drugsfda endpoint) — FDA, 31 July 2026Checked against the source on .The Limitations of Use that appeared in Trulicity's labeling revised 11/2024 — including 'Not for treatment of type 1 diabetes mellitus' — do not appear anywhere in the labeling revised 03/2026. The approved indications are unchanged and remain confined to type 2 diabetes mellitus.
Recorded because the obvious misreading is available and wrong. Verified by text-extracting three labels locally on 2026-08-02: the string 'Limitations of Use' occurs twice in the 11/2024 label and zero times in the labels revised 05/2025 and 03/2026, so the section was dropped in the supplement approved 2025-05-28. The phrase 'type 1 diabetes' now occurs zero times in the current label. This is a change in what the labeling SAYS, not a change in what is approved: section 1 still reads 'type 2 diabetes mellitus' in both indications, so use in type 1 diabetes remains outside the approved indication. Note also that one former limitation survived as a warning rather than disappearing — the current section 5.6 still states that Trulicity 'is not recommended in patients with severe gastroparesis'. We did not identify FDA's stated reason for the removal and are not guessing at one.
TRULICITY (dulaglutide) injection — Prescribing Information (revised 11/2024) — FDA, 4 November 2024“Limitations of Use: • Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in these patients (1, 5.2). • Not for treatment of type 1 diabetes mellitus (1). • Not recommended in patients with severe gastrointestinal disease, including severe gastroparesis (1, 5.6).”
Checked against the source on .
Documented safety signals
Boxed warning — risk of thyroid C-cell tumors. In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. TRULICITY is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
FDA's highest-level warning. The labeling also records human observations that the boxed warning itself does not carry: one case of MTC in a patient treated with Trulicity in a clinical trial, in a patient whose pretreatment calcitonin was approximately eight times the upper limit of normal, and an additional case of C-cell hyperplasia with elevated calcitonin following treatment in the cardiovascular outcomes trial. The labeling states that routine monitoring of serum calcitonin or thyroid ultrasound is of uncertain value for early detection of MTC in treated patients — so the contraindication is a screening question, and screening questions only get asked where there is a prescriber and a label to ask them.
TRULICITY (dulaglutide) injection — Highlights of Prescribing Information — FDA, 12 March 2026“In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined.”
Checked against the source on .Labeled warnings and precautions include thyroid C-cell tumors, acute pancreatitis, hypoglycemia with concomitant use of insulin secretagogues or insulin, hypersensitivity reactions including anaphylactic reactions and angioedema, acute kidney injury due to volume depletion, severe gastrointestinal adverse reactions, diabetic retinopathy complications in patients with a history of diabetic retinopathy, acute gallbladder disease, and pulmonary aspiration during general anesthesia or deep sedation.
Reproduced in full because a nine-item warnings section is not what 'well tolerated' implies. The labeling gives the most common adverse reactions, at an incidence of 5 percent or greater, as nausea, diarrhea, vomiting, abdominal pain and decreased appetite. Postmarketing reports listed in the labeling additionally include hemorrhagic and necrotizing pancreatitis sometimes resulting in death, ileus, intestinal obstruction, cholecystitis, cholelithiasis requiring cholecystectomy, hepatitis, acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis, and alopecia — with FDA's standard caveat that voluntary reports from a population of uncertain size cannot establish frequency or causation.
TRULICITY (dulaglutide) injection — Highlights of Prescribing Information — FDA, 12 March 2026Checked against the source on .Severe gastrointestinal adverse reactions were reported more frequently among patients receiving TRULICITY than placebo in the pool of placebo-controlled trials, and the labeling states that TRULICITY is not recommended in patients with severe gastroparesis. This section was revised in March 2026 and is flagged in the label's own Recent Major Changes.
The most recent substantive change to this label: the Recent Major Changes box reads 'Warnings and Precautions Severe Gastrointestinal Adverse Reactions (5.6) 03/2026'. QUOTE HANDLING: the labeling gives per-arm incidence figures paired with product strengths; those figures are elided with an ellipsis under this site's no-dosing policy. The finding — more frequent on drug than on placebo, and the gastroparesis recommendation — does not depend on them.
TRULICITY (dulaglutide) injection — Highlights of Prescribing Information — FDA, 12 March 2026“Use of TRULICITY has been associated with gastrointestinal adverse reactions, sometimes severe … Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists. TRULICITY is not recommended in patients with severe gastroparesis.”
Checked against the source on .In a cardiovascular outcomes trial with median follow-up of 5.4 years, diabetic retinopathy complications were prospectively ascertained as a secondary composite endpoint and occurred slightly more often in the dulaglutide group than in the placebo group, with a larger proportion affected among patients who had a history of diabetic retinopathy at baseline.
Recorded because it runs the opposite way to the trial's headline. The same trial that produced the cardiovascular benefit produced a retinopathy signal, and the labeling carries both. The per-arm percentages in section 5.7 are stated alongside a product strength and are therefore not reproduced here; the direction of the difference and the history-of-retinopathy subgroup are the parts that matter. The labeling instructs monitoring of patients with a history of diabetic retinopathy.
TRULICITY (dulaglutide) injection — Highlights of Prescribing Information — FDA, 12 March 2026Checked against the source on .In glycemic control trials in adults, 64 of 3,907 TRULICITY-treated patients (1.6%) developed anti-dulaglutide antibodies. Of those, 34 patients (0.9% of the overall population) developed dulaglutide-neutralizing antibodies and 36 patients (0.9%) developed antibodies against native GLP-1. The labeling states no clinically significant effect of anti-drug antibodies on pharmacokinetics, pharmacodynamics, safety or effectiveness was identified over the treatment durations studied.
Included because immunogenicity is a category of risk that exists for this molecule and does not exist in the same form for a synthetic peptide — it is what being a 63 kDa recombinant fusion protein costs. Read the label's own two qualifications: observed anti-drug antibody incidence is highly dependent on assay sensitivity and specificity, and differences in assay methods preclude comparison with other products. The most striking number is the smallest one — antibodies against NATIVE GLP-1, the body's own hormone, in 0.9% of treated patients. The labeling reports no identified clinical consequence; it does not report that there is none.
TRULICITY (dulaglutide) injection — Highlights of Prescribing Information — FDA, 12 March 2026Checked against the source on .
Questions people actually ask
Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.
- Is Trulicity approved for weight loss?
No. The FDA-approved labeling for Trulicity (dulaglutide, BLA 125469) carries two indications and no others: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus, and to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors. Weight management is not among them, and both indications are gated on type 2 diabetes mellitus, so there is no approved use of Trulicity in a patient who does not have type 2 diabetes. Prescribing it for weight loss is off-label use — a decision for a licensed prescriber, and not one this labeling supports. Weight change is reported in the labeling as a trial outcome in the type 2 diabetes studies; a reported outcome in a trial is not an approved indication.
TRULICITY (dulaglutide) injection — Highlights of Prescribing Information — FDA, 12 March 2026“TRULICITY ® is indicated: • As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. • To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.”
Checked against the source on .- Is dulaglutide a peptide?
Not in the sense the peptide market uses the word. FDA's approved labeling describes dulaglutide as 'a fusion protein that consists of 2 identical, disulfide-linked chains, each containing an N-terminal GLP-1 analog sequence covalently linked to the Fc portion of a modified human immunoglobulin G4 (IgG4) heavy chain by a small peptide linker', with an overall molecular weight of approximately 63 kilodaltons, 'produced using mammalian cell (Chinese hamster ovary) culture'. So there is a GLP-1 peptide sequence inside the molecule, but the molecule itself is an antibody-fragment fusion protein roughly twenty times the mass of semaglutide, and it is grown in cultured cells rather than chemically synthesised. That is why dulaglutide is licensed as a biological product under section 351(a) of the Public Health Service Act instead of approved as a drug, and it is the most likely reason dulaglutide does not appear in the research-chemical GLP-1 market: a supplier that can synthesise a short peptide cannot culture a CHO cell line.
TRULICITY (dulaglutide) injection — Highlights of Prescribing Information — FDA, 12 March 2026“Dulaglutide is a human GLP-1 receptor agonist. The molecule is a fusion protein that consists of 2 identical, disulfide-linked chains, each containing an N-terminal GLP-1 analog sequence covalently linked to the Fc portion of a modified human immunoglobulin G4 (IgG4) heavy chain by a small peptide linker and is produced using mammalian cell (Chinese hamster ovary) culture. … The overall molecular weight of dulaglutide is approximately 63 kilodaltons.”
Checked against the source on .- Can dulaglutide be compounded the way semaglutide and tirzepatide were?
No, and the reason is categorical rather than case-by-case. Dulaglutide is approved in a biologics license application — BLA 125469, submitted under section 351(a) of the Public Health Service Act — and FDA has stated that 'Biological products subject to approval in a biologics license application (BLA) under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262) are not eligible for the exemptions in section 503A of the FD&C Act (21 U.S.C. 353a). Biological products subject to approval in a BLA under section 351 of the PHS Act will not be considered for the 503A bulks list.' Dulaglutide accordingly appears in none of Categories 1, 2 or 3 of FDA's 503A bulk drug substances list updated 14 May 2026 — verified by reading the document, where the word does not occur at all. Read the scope precisely: that quotation is from FDA's section 503A guidance and speaks to section 503A. It is not a statement about every possible handling of the licensed product, and FDA has separate guidance covering pharmacies and outsourcing facilities that mix, dilute or repackage biological products outside the scope of an approved BLA.
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act — Guidance for Industry — FDA, 7 January 2025“Biological products subject to approval in a biologics license application (BLA) under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262) are not eligible for the exemptions in section 503A of the FD&C Act (21 U.S.C. 353a). Biological products subject to approval in a BLA under section 351 of the PHS Act will not be considered for the 503A bulks list.”
Checked against the source on .- Has Trulicity been discontinued?
Not according to FDA's own record as of 2 August 2026. Drugs@FDA lists four TRULICITY products under BLA 125469, sponsor ELI LILLY AND CO, and every one of them carries marketing status 'Prescription' — none is listed as discontinued. FDA also approved a labeling supplement to the same application on 12 March 2026, and the resulting prescribing information is the current approved labeling. Web pages stating that Eli Lilly discontinued Trulicity in October 2024 and that it is no longer manufactured or distributed are contradicted by that record. One caution on what this does and does not answer: marketing status in Drugs@FDA is a regulatory field, not a supply report, so it does not establish that a given presentation is available at a given pharmacy. This record did not verify shortage status, and does not claim anything about it.
Drugs@FDA record for BLA 125469 (openFDA drug/drugsfda endpoint) — FDA, 31 July 2026Checked against the source on .- Did a clinical trial show dulaglutide reduces cardiovascular events?
Yes, in one specific population, and FDA approved an indication on that basis. REWIND (NCT01394952) was a multi-national, randomised, placebo-controlled, double-blind phase 3 trial in which 9,901 adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors were randomised to dulaglutide or placebo, both added to standard of care, with a median follow-up of 5.4 years. In that trial, the risk of first occurrence of the primary composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke was significantly reduced (hazard ratio 0.88, 95% CI 0.79 to 0.99), and FDA's supplement approval letter of 21 February 2020 records that the cardiovascular indication was added 'based on the clinical data from Study GBDJ (REWIND), a Phase 3 cardiovascular outcomes trial'. Two limits are worth reading with it. The result belongs to that enrolled population — adults with type 2 diabetes at cardiovascular risk — and the approved indication is written to match it. And the same trial prospectively ascertained diabetic retinopathy complications as a secondary endpoint and found them slightly more common on dulaglutide than on placebo, which is why the approved labeling carries both the cardiovascular indication and a diabetic retinopathy warning.
REWIND — The Effect of Dulaglutide on Major Cardiovascular Events in Patients With Type 2 Diabetes — ClinicalTrials.gov, 21 August 2018“This Prior Approval supplemental biologics application provides for the addition of efficacy and safety information to the Prescribing Information, including a new indication for reduction of major adverse cardiovascular events in adults with type 2 diabetes mellitus, based on the clinical data from Study GBDJ (REWIND), a Phase 3 cardiovascular outcomes trial.”
Checked against the source on .- Is dulaglutide approved for children?
Partly, and the boundary matters. FDA extended one of Trulicity's two indications to children on 17 November 2022: the supplement approval letter states that it 'provides for expansion of the indication for Trulicity, as an adjunct to diet and exercise to improve glycemic control, to pediatric patients 10 years of age and older with type 2 diabetes mellitus.' Only the glycemic-control indication was extended — the cardiovascular indication in the current labeling remains confined to adults, and there is no approved paediatric use for weight management or for type 1 diabetes. Nothing in the extension softens the labeled risks: the boxed warning for risk of thyroid C-cell tumors, and the contraindications in personal or family history of medullary thyroid carcinoma and in Multiple Endocrine Neoplasia syndrome type 2, are not age-limited.
BLA 125469/S-051 Supplement Approval — Trulicity (dulaglutide) injection — FDA, 17 November 2022“This Prior Approval sBLA provides for expansion of the indication for Trulicity, as an adjunct to diet and exercise to improve glycemic control, to pediatric patients 10 years of age and older with type 2 diabetes mellitus.”
Checked against the source on .