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Eli Lilly and Company (LLY) FDA Approvals

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Eli Lilly and Company's Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Eli Lilly and Company (LLY). Over the past two years, Eli Lilly and Company has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Donanemab, donanemab-azbt, EBGLYSS, efsitora, Imlunestrant, Kisunla, and Lebrikizumab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

Donanemab FDA Regulatory Timeline and Events

Donanemab is a drug developed by Eli Lilly and Company for the following indication: Alzheimer's disease (AD). This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Donanemab-azbt FDA Regulatory Events

Donanemab-azbt is a drug developed by Eli Lilly and Company for the following indication: In early symptomatic Alzheimer's disease. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

EBGLYSS FDA Regulatory Timeline and Events

EBGLYSS is a drug developed by Eli Lilly and Company for the following indication: For atopic dermatitis. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Efsitora alfa FDA Regulatory Timeline and Events

Efsitora alfa is a drug developed by Eli Lilly and Company for the following indication: In adults with type 2 diabetes. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Imlunestrant FDA Regulatory Events

Imlunestrant is a drug developed by Eli Lilly and Company for the following indication: oral selective estrogen receptor degrader. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Kisunla FDA Regulatory Events

Kisunla is a drug developed by Eli Lilly and Company for the following indication: For the Treatment of Early Symptomatic Alzheimer's Disease. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Lebrikizumab FDA Regulatory Events

Lebrikizumab is a drug developed by Eli Lilly and Company for the following indication: Atopic dermatitis (AD). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

LY4050784 FDA Regulatory Events

LY4050784 is a drug developed by Eli Lilly and Company for the following indication: pan-KRAS inhibitor. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Mirikizumab FDA Regulatory Events

Mirikizumab is a drug developed by Eli Lilly and Company for the following indication: Moderate to severe ulcerative colitis (UC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Mirikizumab-mrkz FDA Regulatory Events

Mirikizumab-mrkz is a drug developed by Eli Lilly and Company for the following indication: For Crohn's disease. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Pirtobrutinib FDA Regulatory Timeline and Events

Pirtobrutinib is a drug developed by Eli Lilly and Company for the following indication: A non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Tirzepatide FDA Regulatory Timeline and Events

Tirzepatide is a drug developed by Eli Lilly and Company for the following indication: For obesity or overweight with weight-related comorbidities, excluding type 2 diabetes. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Verzenio (abemaciclib) FDA Regulatory Timeline and Events

Verzenio (abemaciclib) is a drug developed by Eli Lilly and Company for the following indication: Hormone Receptor-Positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (EBC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Eli Lilly and Company FDA Events - Frequently Asked Questions

Yes, Eli Lilly and Company (LLY) has received FDA approval for multiple therapies, including mirikizumab-mrkz, tirzepatide and Donanemab. This page tracks recent and historical FDA regulatory events related to Eli Lilly and Company's drug portfolio.

In the past two years, Eli Lilly and Company (LLY) has reported FDA regulatory activity for the following drugs: tirzepatide, Verzenio (abemaciclib), Pirtobrutinib, Donanemab, efsitora alfa, EBGLYSS, Kisunla, mirikizumab-mrkz, mirikizumab, donanemab-azbt, Imlunestrant, LY4050784 and Lebrikizumab.

The most recent FDA-related event for Eli Lilly and Company occurred on July 31, 2025, involving tirzepatide. The update was categorized as "Top-line results," with the company reporting: "Eli Lilly Announced Topline Results From SURPASS-CVOT Head-to-head Phase 3 Trial Comparing Mounjaro (Tirzepatide) To Trulicity (Dulaglutide), Mounjaro Achieved The Primary Objective By Demonstrating A Non-inferior Rate Of Major Adverse Cardiovascular Events, Including Cardiovascular Death, Heart Attack Or Stroke Vs. Trulicity"

Current therapies from Eli Lilly and Company in review with the FDA target conditions such as:

  • For obesity or overweight with weight-related comorbidities, excluding type 2 diabetes. - tirzepatide
  • Hormone Receptor-Positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (EBC) - Verzenio (abemaciclib)
  • A non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult - Pirtobrutinib
  • Alzheimer's disease (AD) - Donanemab
  • In adults with type 2 diabetes - efsitora alfa
  • For atopic dermatitis - EBGLYSS
  • For the Treatment of Early Symptomatic Alzheimer's Disease - Kisunla
  • For Crohn's disease - mirikizumab-mrkz
  • Moderate to severe ulcerative colitis (UC) - mirikizumab
  • In early symptomatic Alzheimer's disease - donanemab-azbt
  • oral selective estrogen receptor degrader - Imlunestrant
  • pan-KRAS inhibitor - LY4050784
  • Atopic dermatitis (AD) - Lebrikizumab

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NYSE:LLY) was last updated on 8/2/2025 by MarketBeat.com Staff
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