Drugs / Orforglipron
Orforglipron
also known as
LY3502970 · [14C]-LY3502970 · LY-3502970 HEMICALCIUM · ORFORGLIPRON CALCIUM · Orforglipron hemicalcium
Small molecule targets GLP1R via activation
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed obesity and hypopigmentation 1 milestone | |||||
| Filed | EU (EMA) | — | obesity and hypopigmentation | — | “submissions for orforglipron for obesity to regulatory authorities in the U.S. and Japan and for obesity and type 2 diabetes in the EU.” lilly.com ↗ |
| Filed obesity disorder 2 milestones | |||||
| Filed | US (FDA) | — | obesity disorder | 2025-12-18 | “Lilly has submitted a new drug application to the U.S. Food and Drug Administration (FDA) for orforglipron for the treatment of adults with obesity” lilly.com ↗ “submissions for orforglipron for obesity to regulatory authorities in the U.S. and Japan and for obesity and type 2 diabetes in the EU.” lilly.com ↗ |
| Filed | Japan (PMDA) | — | obesity disorder | — | “submissions for orforglipron for obesity to regulatory authorities in the U.S. and Japan and for obesity and type 2 diabetes in the EU.” lilly.com ↗ |
| Filed type 2 diabetes mellitus 1 milestone | |||||
| Filed | US (FDA) | — | type 2 diabetes mellitus | 2026-08-05 | “the submission for orforglipron for type 2 diabetes in the U.S.” lilly.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | FOUNDAYO | — | 2026-04-01 | fda.gov ↗ |
Trials 51
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 121 trials · 1 met primary | ||||||
| Phase 1 | NCT06824051 | Feb 2025 → Jan 2026 | obesity disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06692348 | Dec 2024 → Jun 2025 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06704763 | Dec 2024 → Feb 2025 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06440980 | Jun 2024 → Jun 2025 | obesity disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 1 | NCT06370728 | May → Jul 2024 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06186622 | Jan → Jul 2024 | obesity disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06085482 | Oct 2023 → Jan 2024 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06023095 | Sep 2023 → Jul 2024 | obesity disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05936138 | Jul 2023 → Apr 2024 | impaired renal function disease | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05882032 | Jun 2023 → Nov 2024 | liver disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05841238 | Apr → Sep 2023 | obesity disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05573230 | Oct 2022 → Jan 2023 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05469126 | Aug → Nov 2022 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05313802 | May → Sep 2022 | obesity disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05341089 | May → Sep 2022 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05086445 | Nov 2021 → Sep 2022 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05110794 | Nov 2021 → Feb 2022 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05051566 | Sep 2021 → Apr 2022 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04680767 | Mar → Jul 2021 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04426474 | Oct 2020 → Jul 2021 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03929744 | Jun 2019 → Nov 2020 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 23 trials · 2 met primary | ||||||
| Phase 2 | NCT07107334 | Apr 2026 → Nov 2028 expected | endometrial endometrioid adenocarcinoma | University of Florida | Recruiting | No outcome recorded |
| Phase 2 | NCT05051579 | Sep 2021 → Aug 2022 | obesity disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT05048719 | Sep 2021 → Sep 2022 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 326 trials · 8 met primary | ||||||
| Phase 3 | NCT07668336 | Sep 2026 → Mar 2030 expected | type 2 diabetes mellitus | Eli Lilly and Company | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07794579 | Aug 2026 → Aug 2029 expected | abdominal obesity-metabolic syndrome, hypertensive disorder, obesity disorder, prediabetes syndrome | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 3 | NCT07613307 | Jul 2026 → May 2027 expected | type 2 diabetes mellitus | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 3 | NCT07241390 | Dec 2025 → Aug 2031 expected | atherosclerotic cardiovascular disease, chronic kidney disease | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 3 | NCT07223593 | Oct 2025 → Jun 2028 expected | peripheral arterial disease | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 3 | NCT07202884 | Sep 2025 → Mar 2028 expected | female stress incontinence | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 3 | NCT07153471 | Sep 2025 → Apr 2028 expected | osteoarthritis | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06972472 | May 2025 → Aug 2027 expected | obesity disorder, type 2 diabetes mellitus | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06972459 | May 2025 → Aug 2027 expected | obesity disorder | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06993792 | May 2025 → Aug 2027 expected | obesity disorder, type 2 diabetes mellitus | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06952530 | Apr 2025 → Sep 2027 expected | hypertensive disorder | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06948435 | Apr 2025 → Sep 2027 expected | hypertensive disorder, obesity disorder | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06948422 | Apr 2025 → Sep 2027 expected | hypertensive disorder | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06672939 | Nov 2024 → Dec 2027 expected | obesity disorder | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 3 | NCT06672549 | Nov 2024 → Feb 2027 expected | obesity disorder | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 3 | NCT06649045 | Oct 2024 → Jul 2026 | obesity disorder, obstructive sleep apnea syndrome | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT06584916 | Sep 2024 → Nov 2025 | obesity disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT06192108 | Jan 2024 → Sep 2025 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT06109311 | Nov 2023 → Sep 2025 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT06010004 | Sep 2023 → Jun 2025 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT06045221 | Sep 2023 → Aug 2025 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT05971940 | Aug 2023 → Apr 2025 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT05931380 | Jul 2023 → Jun 2025 | obesity disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT05872620 | Jun 2023 → Aug 2025 | obesity disorder, type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT05869903 | Jun 2023 → Jul 2025 overdue | obesity disorder | Eli Lilly and Company | Active not recruiting | Met primary |
| Phase 3 | NCT05803421 | Apr 2023 → Mar 2026 | cardiovascular disorder, chronic kidney disease, obesity disorder, type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07739537 | Oct 2026 → Sep 2029 expected | type 2 diabetes mellitus | Massachusetts General Hospital | Not yet recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT07793019 Comparator | Sep 2026 → Sep 2027 expected | obesity disorder | Innovent Biologics (Suzhou) Co. Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2026-10-01 | Eli Lilly and Company | Results Lilly's oral GLP-1, Foundayo (orforglipron), was associated with significant reductions in predicted long-term risk of type 2 diabetes and cardiovascular disease lilly.com ↗
In post-hoc analyses of ATTAIN-1, Foundayo 17.2 mg was associated with a predicted 57% and 18% reduction in risk of type 2 diabetes and cardiovascular disease vs. placebo |
| 2026-09-30 | Eli Lilly and Company | Results Lilly's oral GLP-1, Foundayo (orforglipron), demonstrated cardiovascular safety alongside sustained A1C reduction and weight loss in its largest and longest type 2 diabetes study lilly.com ↗
In ACHIEVE-4, participants taking Foundayo experienced a 16% lower risk of MACE-4 and a 23% lower risk of MACE-3, meeting the primary objective for non-inferiority compared to insulin glargine |
| 2026-09-29 | Eli Lilly and Company | Results Lilly's Foundayo (orforglipron) 17.2 mg showed greater weight loss and A1C reduction than oral semaglutide 25 mg among adults with type 2 diabetes in a new indirect treatment comparison lilly.com ↗
In an indirect treatment comparison using data from ACHIEVE-3 and PIONEER PLUS, Foundayo 17.2 mg showed significantly greater weight loss and A1C reduction compared to oral semaglutide 25 mg at 52 weeks. |
| 2026-09-15 | Eli Lilly and Company | Results Lilly to present new data on Foundayo, retatrutide, and eloraTZP at EASD 2026, as it strives to change the course of cardiometabolic health lilly.com ↗
ACHIEVE-4: Foundayo demonstrated non-inferiority versus insulin glargine, with a 16% lower risk of MACE-4 events (HR: 0.84; 95.0% CI: 0.59 to 1.20) and a 23% lower risk of MACE-3 events (HR: 0.77 95.0% CI: 0.52 to 1.13), in adults with type 2 diabetes and obesity or overweight at increased cardiovascular risk. |
| 2026-06-08 | Eli Lilly and Company | Results Lilly's oral GLP-1 Foundayo (orforglipron) delivered superior A1C control and weight loss in three pivotal type 2 diabetes trials lilly.com ↗
In the landmark head-to-head ACHIEVE-3 trial, Foundayo outperformed oral semaglutide across the primary and all key secondary endpoints. |
| 2026-06-07 | Eli Lilly and Company | Results Lilly's Foundayo (orforglipron), the only oral GLP-1 taken without food or water restrictions, was associated with significant weight loss in women at every stage of menopause lilly.com ↗
These findings, based on post-hoc analyses of more than 1,500 female participants in the ATTAIN-1 and ATTAIN-2 clinical trials, were presented at the American Diabetes Association (ADA) 86th Scientific Sessions. |
| 2026-05-28 | Eli Lilly and Company | Results Lilly to present new data on Foundayo, Mounjaro and retatrutide at the American Diabetes Association's 86th Scientific Sessions, building toward a new era of choice in diabetes and obesity care lilly.com ↗
ACHIEVE-3: Foundayo was superior to oral semaglutide in type 2 diabetes, delivering better A1C reduction and 73.6% greater relative weight loss at 52 weeks. |
| 2026-05-22 | Eli Lilly and Company | Results Foundayo (orforglipron), a once-daily pill taken without food or water restrictions, was associated with reduced body weight of up to 13% in adults 65 and older with obesity or overweight, in new analysis of ATTAIN-1/2 lilly.com ↗
Once-daily oral Foundayo was associated with statistically significant body weight reductions vs. placebo in adults ≥65 years at all three doses studied at 72 weeks (p<0.001 for all) |
| 2026-05-12 | Eli Lilly and Company | Results Lilly's Foundayo and lower-dose Zepbound helped people maintain weight loss after switching from higher doses of injectable incretin therapy in two late-phase trials lilly.com ↗
In ATTAIN-MAINTAIN, participants who transitioned from a maximum tolerated dose (MTD) of Wegovy (semaglutide) to Foundayo maintained all but 0.9 kg of their previously achieved weight loss on average after one year |
| 2026-04-16 | Eli Lilly and Company | Results ACHIEVE-4, the longest Phase 3 study of Lilly's Foundayo (orforglipron) to date, reaffirmed its cardiovascular and overall safety profile as well as consistent improvements across key measures of cardiometabolic health lilly.com ↗
In the trial, Foundayo met the primary endpoint by demonstrating a non-inferior risk of major adverse cardiovascular events (MACE-4), including cardiovascular death, heart attack, stroke or hospitalization for unstable and sudden chest pain, compared to insulin glargine. |
| 2026-04-02 | Eli Lilly and Company | Regulatory La FDA aprueba Foundayo™ (orforglipron) de Lilly, la única pastilla GLP-1 para la pérdida de peso que puede tomarse a cualquier hora del día sin restricciones de comida o agua lilly.com ↗
Eli Lilly and Company (NYSE: LLY) ha anunciado hoy que la Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) aprobó Foundayo™ (orforglipron) para adultos con obesidad o con sobrepeso que también tienen problemas médicos relacionados con este. |
| 2026-04-01 | Eli Lilly and Company | Regulatory FDA approves Lilly's Foundayo™ (orforglipron), the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) approved Foundayo™ (orforglipron) for adults with obesity, or overweight with weight-related medical problems. |
| 2026-02-26 | Eli Lilly and Company | Results Lilly's oral GLP-1, orforglipron, delivered superior blood sugar control and weight loss compared to oral semaglutide in head-to-head type 2 diabetes trial published in The Lancet lilly.com ↗
In ACHIEVE-3, orforglipron outperformed oral semaglutide across the primary and all key secondary endpoints, delivering significantly greater improvements in A1C and weight. |
| 2025-12-18 | Eli Lilly and Company | Results Lilly's orforglipron helped people maintain weight loss after switching from injectable incretins to oral GLP-1 therapy in first-of-its-kind Phase 3 trial lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the ATTAIN-MAINTAIN trial. |
| 2025-10-15 | Eli Lilly and Company | Results Lilly's oral GLP-1, orforglipron, demonstrated superior glycemic control in two successful Phase 3 trials, reconfirming its potential as a foundational treatment in type 2 diabetes lilly.com ↗
In ACHIEVE-2, orforglipron lowered A1C by up to 1.7% compared to 0.8% with dapagliflozin, meeting the primary endpoint |
| 2025-09-17 | Eli Lilly and Company | Results Lilly's oral GLP-1, orforglipron, superior to oral semaglutide in head-to-head trial lilly.com ↗
At 52 weeks, orforglipron met the primary and all key secondary endpoints across each dose comparison vs. oral semaglutide, delivering greater improvements in A1C and weight. |
| 2025-09-16 | Eli Lilly and Company | Results Lilly's oral GLP-1, orforglipron, demonstrated meaningful weight loss and cardiometabolic improvements in complete ATTAIN-1 results published in The New England Journal of Medicine lilly.com ↗
At 72 weeks, all three doses (6 mg, 12 mg and 36 mg) of orforglipron met the primary endpoint of superior body weight reduction compared to placebo. |
| 2025-08-26 | Eli Lilly and Company | Results Lilly's oral GLP-1, orforglipron, is successful in third Phase 3 trial, triggering global regulatory submissions this year for the treatment of obesity lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the Phase 3 ATTAIN-2 trial, evaluating orforglipron, an investigational oral GLP-1 receptor agonist, in adults with obesity or overweight and type 2 diabetes. |
| 2025-08-07 | Eli Lilly and Company | Results Lilly's oral GLP-1, orforglipron, delivers weight loss of up to an average of 27.3 lbs in first of two pivotal Phase 3 trials in adults with obesity lilly.com ↗ |
| 2025-06-21 | Eli Lilly and Company | Results Lilly's oral GLP-1, orforglipron, showed compelling efficacy and a safety profile consistent with injectable GLP-1 medicines, in complete Phase 3 results published in The New England Journal of Medicine lilly.com ↗
At 40 weeks, all three doses (3 mg, 12 mg, 36 mg) of orforglipron achieved the primary endpoint of superior A1C reduction. |
| 2025-05-01 | Eli Lilly and Company | Results Lilly reports first-quarter 2025 financial results and highlights pipeline momentum lilly.com ↗
Pipeline progress included positive Phase 3 trial results for orforglipron (small molecule oral GLP-1 agonist) in Type 2 diabetes in the first of seven obesity and diabetes Phase 3 trials. |
| 2025-04-17 | Eli Lilly and Company | Results Lilly's oral GLP-1, orforglipron, demonstrated statistically significant efficacy results and a safety profile consistent with injectable GLP-1 medicines in successful Phase 3 trial lilly.com ↗
today announced positive topline Phase 3 results from ACHIEVE-1, evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. |
| 2023-06-23 | Eli Lilly and Company | Results Lilly's phase 2 results published in the New England Journal of Medicine show orforglipron, a once-daily oral nonpeptide GLP-1 receptor agonist, achieved up to 14.7% mean weight reduction at 36 weeks in adults with obesity or overweight lilly.com ↗
Orforglipron met both primary and secondary endpoints for the efficacy estimandii and demonstrated clinically significant weight reductions in adults with obesity or overweight, with at least one weight-related comorbidity (not including type 2 diabetes). |
All press releases naming this drug 26 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 55 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | orforglipron | “Subjects will receive a glucagon-like peptide 1 receptor agonist (either semaglutide, tirzepatide or liraglutide) by self-injection or orally (semaglutide or orforglipron) for...” NCT07107334 ↗37“Daily oral orforglipron, a nonpeptide GLP-1 receptor agonist, was associated with weight reduction.” PMID 37351564 ↗ Jun 2023 “orforglipron (LY3502970), an oral, non-peptide glucagon-like peptide 1 receptor agonist (GLP-1 RA)” PMID 38402332 ↗ Feb 2024 “Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist.” PMID 38402332 ↗ Feb 2024 |
| Known as | [14C]-LY3502970 | “Participants received a single oral dose of 1 milligram (mg) LY3502970 followed six hours later by an intravenous (IV) dose of approximately 21 microgram (μg) of LY3502970...” NCT06085482 ↗ |
| Known as | LY-3502970 HEMICALCIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL4446782 ↗ |
| Known as | LY3502970 | “A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening)” NCT06948422 ↗20“A Master Protocol for Orforglipron (LY3502970) in Participants With Obesity or Overweight With and Without Type 2 Diabetes” NCT06993792 ↗ “A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity” NCT06972459 ↗ “A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities” NCT06672939 ↗ “orforglipron (LY3502970), an oral, non-peptide glucagon-like peptide 1 receptor agonist (GLP-1 RA)” PMID 38402332 ↗ Feb 2024 |
| Known as | ORFORGLIPRON CALCIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL4446782 ↗ |
| Known as | Orforglipron hemicalcium | ChEMBL registry synonym — accepted as the source's own label CHEMBL4446782 ↗ |
| Action | Activate | “orforglipron (LY3502970), an oral, non-peptide glucagon-like peptide 1 receptor agonist (GLP-1 RA)” PMID 38402332 ↗ Feb 2024 |
| Modality | Small molecule | “orforglipron (LY3502970), an oral, non-peptide glucagon-like peptide 1 receptor agonist (GLP-1 RA)” PMID 38402332 ↗ Feb 2024 |
| Route | Oral | “Administered orally.” NCT03929744 ↗ |
| Target | GLP1R | “glucagon-like peptide-1 (GLP-1) receptor agonist” PMID 42120723 ↗ May 2026 |