When Is MariTide Expected to Launch?
MariTide (maridebart cafraglutide) is a new investigational medication in the obesity and weight loss drug pipeline. Developed by Amgen, this next-generation therapy has generated major interest in the biotech and pharma worlds due to its potential for significant weight loss, convenient monthly dosing, and a unique design that blends peptide and antibody technologies.
But the big question for patients and providers is simple: When will MariTide become available?
Let’s break down what we know based on the latest data, statements from Amgen, and insights from clinical research.
MariTide’s Launch Timeline: The Short Answer
As of now, MariTide is not yet FDA-approved. The drug has completed a Phase 2 study, and Amgen has indicated plans to move it into late-stage, Phase III clinical trials.
Projected launch window: 2027–2028 (estimated)
This prediction is based on the:
- Typical FDA review timelines for obesity drugs.
- Need for large, long-term cardiovascular, kidney disease, and type 2 diabetes safety studies.
- Multiyear nature of Phase III programs.
- Regulatory steps required for an injectable, chronic therapy.
While Amgen has not provided a firm public release date, analysts expect MariTide to enter the market after 2026, assuming successful trial results and no major adverse events.
Why MariTide Is Generating So Much Attention
MariTide is unique because it uses a peptide-antibody conjugate, a long-acting hybrid that combines a monoclonal antibody with a peptide. This design targets both the GLP-1 receptor (glucagon-like peptide 1) and the GIP receptors (glucose-dependent insulinotropic polypeptide), offering a dual mechanism that is not on the market today.
Unlike existing GLP-1 therapies from companies like Novo Nordisk (Wegovy/Ozempic, semaglutide) and Eli Lilly (Zepbound/Mounjaro, tirzepatide), MariTide acts as both a GLP-1 receptor agonist and a GIPR antagonist, which may help with:
- Increased body weight reduction.
- Improved durability compared to weekly injections.
- Better cardiometabolic markers, such as blood pressure, HbA1c, and cholesterol.
Where the Research Stands: Clinical Trials So Far
The most detailed data on MariTide come from its Phase 2 trial, which included weekly and monthly regimens compared with placebo.
Key findings from the Phase 2 study:
- Significant average weight loss across multiple doses.
- Continued reductions in body weight without an early plateau.
- Encouraging results in participants with type 2 diabetes.
- Improvements in cardiometabolic risk markers.
- Potential benefits for related conditions like obstructive sleep apnea, heart failure, and cardiovascular disease.
The results were shared at major meetings like the American Diabetes Association and published in journals like the New England Journal of Medicine (NEJM).
Amgen has emphasized that lower doses and adjusted dose escalation schedules have improved tolerability, especially related to gastrointestinal side effects like nausea and constipation, which are common issues with all GLP-1 therapies.
How MariTide Compares to Today’s Leading Weight-Loss Medications
Current leaders in the market include:
Shop Medications
These drugs require frequent dosing, typically weekly injections.
MariTide’s long half-life could allow for monthly dosing, which could improve adherence for people managing obesity, type 2 diabetes, or related heart conditions.
Why MariTide Needs Phase III Trials Before an FDA Decision
To be approved by the FDA, MariTide must complete full Phase III clinical trials. These are large-scale studies that measure:
- Long-term safety.
- Potential side effects.
- Rates of discontinuation.
- Outcomes for metabolic conditions.
- Impacts on cardiovascular and kidney disease.
- How it performs in diverse patient populations.
- Comparisons with existing drugs, especially those from Novo Nordisk and Eli Lilly.
Given the scrutiny on modern obesity drug programs, regulators place special focus on:
- Sustained weight reduction.
- Potential safety issues (GI side effects, pancreatitis, cardiac effects).
- Real-world impact on blood pressure, HbA1c, and cholesterol.
This process takes time, which is usually several years.
Pricing Expectations: What Could MariTide Cost?
While Amgen has not announced a price, analysts expect it to compete with:
- Wegovy
- Zepbound
- Other leading GLP-1 medications
That means MariTide could fall in a similar range: $900–$1,300 per month in the U.S. before insurance, depending on the final dose and medication.
Amgen may highlight reduced frequent dosing as a cost-efficiency advantage if it leads to better adherence.
What MariTide’s Launch Could Mean for Patients
If approved, MariTide might offer:
- A potent new option for the treatment of obesity.
- Benefits for type 2 diabetics.
- Significant improvements in cardiovascular risk factors.
- Relief from related conditions like sleep apnea, fatty liver, and certain kidney disorders.
- Fewer injections and better adherence per year compared to current GLP-1 therapies.
Bottom Line: When Will MariTide Launch?
MariTide is moving toward Phase III, and if all goes as planned, the drug could reach the market around 2027–2028.
For now, MariTide remains one of the most exciting late-stage candidates in the pharma pipeline. This is particularly true because of its peptide-antibody conjugate structure, potential for monthly dosing, and impressive early results in weight reduction and cardiometabolic health.
The next major milestone will be the start of Phase III clinical trials, followed by an FDA submission once Amgen confirms safety and effectiveness.
Sources
- Jastreboff, A. M., et al. MariTide Phase 2 Obesity Trial Investigators (2025). Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity – A Phase 2 Trial. The New England Journal of Medicine. DOI: 10.1056/NEJMoa2504214. Accessed Nov. 25, 2025.
- AMGEN ANNOUNCES ROBUST WEIGHT LOSS WITH MARITIDE IN PEOPLE LIVING WITH OBESITY OR OVERWEIGHT AT 52 WEEKS IN A PHASE 2 STUDY. (2024, November 26). Amgen. Accessed Nov. 25, 2025.
- Amgen’s experimental weight-loss drug needs lower dose to limit side effects. Reuters. Accessed Nov. 25, 2025.