Foundayo

(Orforglipron)

ApprovedSmall molecule

Foundayo is a small molecule that works as a GLP-1 Receptor Agonist.[2] It is being used across 7 indications, with its most advanced program in Approved.[1]

Foundayo is one of 143 small molecule programs targeting Type 2 Diabetes. It is currently in Approved.

Indications

Total Trials

Active Trials

142

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Type 2 DiabetesCompleted

HyperglycemiaActive, not recruiting

Diabetes Mellitus, Type 2Recruiting

Diabete Type 2Not yet recruiting

Prediabetic StateNot yet recruiting

ObesityActive, not recruiting

HypertensionRecruiting

Type 2 DiabetesPhase 3

Completed

HyperglycemiaPreclinical

Active, not recruiting

Diabetes Mellitus, Type 2Phase 3

Recruiting

Diabete Type 2Approved

Not yet recruiting

Prediabetic StatePhase 3

Not yet recruiting

ObesityApproved

Active, not recruiting

HypertensionPhase 3

Recruiting

Competition

Competitive Landscape

190 competitors in Obesity

#DrugCompanyPhaseTrials

Foundayo

Eli Lilly

Approved

10 2

Vivia

SSpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

Phase 3

1 3

Synthroid

IInstitut Jerome Lejeune

Phase 3

1 4

NNC0487-0111

Novo Nordisk

Phase 3

11 5

Cagrisema

Novo Nordisk

Phase 3

5 6

Zenagamtide

Novo Nordisk

Phase 3

3 7

Berobenatide

Pfizer

Phase 3

3 8

Mibavademab

Regeneron

Phase 3

2 9

Ribupatide

KKailera

Phase 3

3 10

PF-08653944

Pfizer

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Recruiting

Obesity

NCT06672549

Q2 2027

Phase 3Recruiting

Diabetes Mellitus, Type 2

NCT07613307

Q3 2027

Phase 3Recruiting

Type 2 Diabetes

NCT06972472

Phase 3Active, not recruiting

Obesity

NCT06993792

Phase 3Active, not recruiting

Obesity

NCT06972459

Phase 3Recruiting

Hypertension

NCT06948422

Clinical

Trials by Indication[1]

Obesity10 trials

A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of Single-Dose IBI3042 in Healthy Participants and Multiple-Dose IBI3042 in Overweight or Obese Participants

Recruiting· Innovent Biologics (Suzhou) Co. Ltd. logo

Innovent Biologics (Suzhou) Co. Ltd.·Phase 1·NCT07793019·104 enrolled

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT05872620·1,613 enrolled

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once- Daily Oral Orforglipron Compared With Placebo in Chinese Adult Participants With Obesity or Overweight With Weight-Related Comorbidities

Not yet recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT07790861·192 enrolled

Show 7 more trials

A Master Protocol for a Randomized, Controlled, Clinical Platform Trial to Investigate the Efficacy and Safety of Interventions for Chronic Weight Management in Pediatric Participants With Obesity or Overweight

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT06672549·125 enrolled

Efficacy, Safety, and Pharmacokinetics of Orforglipron Once Daily Oral Versus Placebo in Adolescent Participants Who Have Obesity, or Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (ADVANCE-ATTAIN-ADOLESCENTS)

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT06672939·150 enrolled

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral Orforglipron Compared With Placebo in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1)

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT05869903·3,127 enrolled

A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared With Placebo in Participants With Obesity or Overweight With and Without Type 2 Diabetes

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT06993792·1,400 enrolled

A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared With Placebo in Participants With Obesity or Overweight With and Without Type 2 Diabetes

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT06972459·800 enrolled

Switching to Oral Weight Management Pharmacotherapy to Prevent Weight Regain After GLP-1-based Therapy Discontinuation

Not yet recruiting·MMassachusetts General Hospital·Approved·NCT07729332·60 enrolled

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Japanese Adult Participants With Obesity Disease

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT05931380·238 enrolled

Type 2 Diabetes7 trials

A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT06109311·546 enrolled

A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT06192108·962 enrolled

A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT05803421·2,749 enrolled

Show 4 more trials

A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Type 2 Diabetes

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT06972472·600 enrolled

A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Oral Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (ACHIEVE-3)

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT06045221·1,698 enrolled

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT05971940·559 enrolled

A Phase 3, Long-term Safety Study of LY3502970 in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone or in Combination With Oral Antihyperglycemic Medications (ACHIEVE-J)

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT06010004·401 enrolled

Hypertension3 trials

A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening)

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT06948422·974 enrolled

A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL2

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT06952530·487 enrolled

A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT06948435·487 enrolled

Interaction2 trials

A Drug-Drug Interaction Study of Orforglipron (LY3502970) With Quinidine in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06704763·27 enrolled

A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06186622·50 enrolled

Overweight2 trials

A Study of Orforglipron for the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-MAINTAIN)

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT06584916·376 enrolled

A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06824051·120 enrolled

11 more indications

Diabetes Mellitus, Type 22 trials

A Phase 3b, Multicenter, Multi-Country, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of Orforglipron in Adult Participants With Type 2 Diabetes Who Observe Ramadan Fasting (ACHIEVE-RAM)

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT07613307·130 enrolled

A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Once-Daily Oral Orforglipron Compared With Once-Weekly Dulaglutide in Pediatric Participants 10 to Less Than 18 Years of Age With Type 2 Diabetes

Not yet recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT07668336·170 enrolled

ART1 trial

A Study of Orforglipron (LY3502970) to Compare a Single Capsule and Multiple Capsules in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06692348·86 enrolled

OSA1 trial

A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obstructive Sleep Apnea and Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT06649045·712 enrolled

Atherosclerosis Cardiovascular Disease1 trial

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT07241390·7,140 enrolled

Urinary Incontinence,Stress1 trial

A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared With Placebo in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT07202884·1,000 enrolled

Osteoarthritis1 trial

A Phase 3 Study to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee: A Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Trial

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT07153471·800 enrolled

Peripheral Arterial Disease1 trial

A Study to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants With Peripheral Artery Disease: A Randomized, Double-Blind, Placebo Controlled Trial

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT07223593·1,205 enrolled

Diabete Type 21 trial

Polygenic Assessment and Testing of Heterogeneity and Subtypes in Type 2 Diabetes (PATHS-T2D): A Recall-by-Genotype Study of Physiologic and Pharmacologic Responses

Not yet recruiting·MMassachusetts General Hospital·Approved·NCT07739537·100 enrolled

Prediabetic State1 trial

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Once-Daily Oral Orforglipron Compared With Placebo in Individuals With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity

Not yet recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT07794579·2,001 enrolled

Obese1 trial

A Multiple-Dose Study to Investigate the Bioequivalence of Orforglipron (LY3502970) Capsules and Orforglipron Tablets in Participants With Obesity or Overweight Who Are Otherwise Healthy.

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06440980·533 enrolled

Unspecified1 trial

A Drug-Drug Interaction Study to Assess the Effect of Carbamazepine on the Pharmacokinetics of Orforglipron in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06370728·30 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 1, 2026

FOUNDAYO

NDA NDA220934

Sources

References

[1]
ClinicalTrials.gov — 36 trial records for Orforglipron. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Orforglipron compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Orforglipron. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA220934). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Foundayo. U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Orforglipron. U.S. National Library of Medicine.
[7]
SEC EDGAR — Eli Lilly company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: GLP-1 Receptor Agonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Eli Lilly

Patent Landscape[5]

Patent Cliff

Sep 26, 2037

Earliest patent expiration — generic entry possible after this date

Patent #Expires

RE50455Sep 26, 2037

Key Publications[6]

Orforglipron, an Oral GLP-1 Agonist, in Obesity: Phase 2

N Engl J MedJun 23, 2023DOI: 10.1056/NEJMoa2302392

Foundayo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Obesity10 trials

Type 2 Diabetes7 trials

Hypertension3 trials

Interaction2 trials

Overweight2 trials

Diabetes Mellitus, Type 22 trials

ART1 trial

OSA1 trial

Atherosclerosis Cardiovascular Disease1 trial

Urinary Incontinence,Stress1 trial

Osteoarthritis1 trial

Peripheral Arterial Disease1 trial

Diabete Type 21 trial

Prediabetic State1 trial

Obese1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Key Publications[6]

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