Insulet (PODD) FDA Approvals

Insulet's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Insulet (PODD). Over the past two years, Insulet has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Omnipod. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Omnipod 5 FDA Regulatory Timeline and Events

Omnipod 5 is a drug developed by Insulet for the following indication: Automated Insulin Delivery System for with type 1 diabetes (T1D). 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.

Provided Update - June 3,2026

• Drug: Omnipod 5
• Announced Date: June 3, 2026
• Indication: Automated Insulin Delivery System for with type 1 diabetes (T1D)

Insulet Corporation announced the U.S. rollout of new algorithm enhancements for the Omnipod 5 Automated Insulin Delivery (AID) System.

Insulet Corporation announced the U.S. rollout of new algorithm upgrades for the Omnipod 5 Automated Insulin Delivery system. The enhanced algorithm is designed to help users manage glucose more effectively, including better support for staying in Automated Mode with fewer interruptions during long periods of high blood sugar.

The update also introduces a lower 100 mg/dL Target Glucose option, giving users more flexibility in how they manage diabetes. To speed access, Insulet started shipping compatible Pods to U.S. retail channels before the rollout. Users will get the software update through their Omnipod 5 Controller or mobile app, and more features will become available as the compatible Pods reach users.

Insulet also said the system will offer expanded sensor choice with compatibility for Abbott’s Libre 3 Plus sensor.

Provided Update - February 5,2026

• Drug: Omnipod 5
• Announced Date: February 5, 2026
• Indication: Automated Insulin Delivery System for with type 1 diabetes (T1D)

Insulet Corporation announced its transformative Omnipod 5 Automated Insulin Delivery (AID) System is now available in the Middle East – including Saudi Arabia, Kuwait, Qatar, and the United Arab Emirates (UAE).

Insulet Corporation announced the Omnipod 5 Automated Insulin Delivery (AID) System is now commercially available in Saudi Arabia, Kuwait, Qatar, and the United Arab Emirates. The tubeless, wearable system is compatible with Abbott and Dexcom continuous glucose sensors — specifically Abbott FreeStyle Libre 2 Plus and Dexcom G7 in Saudi Arabia, Kuwait and the UAE, and Dexcom G7 in Qatar.

Omnipod 5 automatically adjusts insulin every five minutes, reducing the need for multiple daily injections and helping improve time in range and lower HbA1c. The waterproof pod is discreet and works day and night to correct highs and help protect against lows. It is indicated for people aged two years and older with type 1 diabetes.

Insulet also launched Omnipod Discover, a diabetes data management platform introduced first in these Middle Eastern markets to simplify information for users and healthcare providers, with plans to expand to other Omnipod 5 markets.

Provided Update - December 4,2025

510(k)

• Drug: Omnipod 5
• Announced Date: December 4, 2025
• Indication: Automated Insulin Delivery System for with type 1 diabetes (T1D)

Insulet Corporation announced it has received FDA 510(k) clearance for significant enhancements to the Omnipod 5 Automated Insulin Delivery System.

Insulet Corporation announced it has received FDA 510(k) clearance for major enhancements to the Omnipod 5 Automated Insulin Delivery System. The update adds a new 100 mg/dL Target Glucose and expands target options to six settings from 100–150 mg/dL in 10 mg/dL steps, letting healthcare providers fine-tune insulin delivery for tighter glucose control. Insulet says the lower target supports people aiming for improved time in range without a meaningful rise in low blood sugar.

The upgraded algorithm also helps users stay in Automated Mode with fewer interruptions, improving day-to-day convenience and confidence. These changes are designed to make therapy more personalized and easier to manage, helping clinicians adjust treatment more effectively. The company expects the updates to roll out in the United States in the first half of 2026 for approved age groups.Read Announcement

Provided Update - August 26,2024

• Drug: Omnipod 5
• Announced Date: August 26, 2024
• Indication: Automated Insulin Delivery System for with type 1 diabetes (T1D)

Insulet Corporation announced its groundbreaking Omnipod 5 Automated Insulin Delivery System (Omnipod 5) is now indicated for use by people with type 2 diabetes (ages 18 years and older) in the U.S., making it the first and only AID system FDA-cleared for both type 1 and type 2 diabetes management.

Insulet Corporation has announced that its Omnipod 5 Automated Insulin Delivery System is now approved for use by people with type 2 diabetes aged 18 and older in the U.S. This milestone makes Omnipod 5 the first and only automated insulin delivery (AID) system that is FDA-cleared for managing both type 1 and type 2 diabetes. This groundbreaking approval opens new possibilities for approximately 6 million U.S. patients with insulin-requiring type 2 diabetes who can now benefit from its innovative, tubeless design and automated technology.

Designed to simplify diabetes management, the Omnipod 5 uses SmartAdjust™ technology to automatically adjust insulin delivery every five minutes. The system helps users achieve better glycemic control without the need for multiple daily injections, offering improved health outcomes and enhanced freedom for people managing their diabetes.

Positive Results - June 21,2024

• Drug: Omnipod 5
• Announced Date: June 21, 2024
• Indication: Automated Insulin Delivery System for with type 1 diabetes (T1D)

Insulet Corporation shared positive results from its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) type 2 diabetes pivotal trial at the American Diabetes Association (ADA) 84th Scientific Sessions in Orlando, Florida. This landmark study evaluated the impact of AID in a diverse group of people with type 2 diabetes who require insulin.

Insulet Corporation recently presented positive findings at the ADA 84th Scientific Sessions in Orlando, Florida, from its Omnipod 5 Automated Insulin Delivery System type 2 diabetes pivotal trial. This landmark study, the largest and most racially diverse to date, involved people with type 2 diabetes who require insulin. The trial showed that using Omnipod 5 significantly improved blood sugar control by reducing HbA1c levels, lowering time in hyperglycemia, and increasing the period spent in the healthy target range without increasing hypoglycemia risk. Participants also experienced a reduction in the daily insulin dose and a meaningful decrease in diabetes distress. Insulet has submitted the trial results to the FDA in hopes of expanding Omnipod 5’s use for people with type 2 diabetes, aiming for a potential U.S. launch in early 2025.