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Zepbound (tirzepatide) is manufactured by Eli Lilly and Company, a leading pharmaceutical corporation based in Indianapolis, Indiana. Approved by the FDA in November 2023 for chronic weight management, Zepbound represents a significant advancement in obesity treatment. As a dual GIP and GLP-1 receptor agonist, this once-weekly injectable medication works through multiple mechanisms to reduce appetite and support weight loss when combined with diet and exercise. Understanding the manufacturer behind Zepbound provides insight into the rigorous development, clinical research, and quality standards that brought this innovative treatment to patients with obesity or overweight with weight-related conditions.
Summary: Zepbound is manufactured by Eli Lilly and Company, a global pharmaceutical corporation headquartered in Indianapolis, Indiana, which developed tirzepatide through extensive clinical trials and received FDA approval in November 2023.
We offer compounded medications and Zepbound®. Compounded medications are prepared by licensed pharmacies and are not FDA-approved. References to Wegovy®, Ozempic®, Rybelsus®, Mounjaro®, or Saxenda®, or other GLP-1 brands, are informational only. Compounded and FDA-approved medications are not interchangeable.
Zepbound is manufactured by Eli Lilly and Company, a global pharmaceutical corporation headquartered in Indianapolis, Indiana. Established in 1876, Eli Lilly has a long-standing history in developing innovative medications across multiple therapeutic areas, including diabetes, oncology, and metabolic disorders.
The development of Zepbound (tirzepatide) represents a significant milestone in Eli Lilly's cardiometabolic portfolio. The company invested substantial resources into the clinical research program that led to tirzepatide's approval for chronic weight management. This same active ingredient was previously approved by the FDA under the brand name Mounjaro for type 2 diabetes management in May 2022, demonstrating Eli Lilly's focus on addressing interconnected metabolic conditions.
Eli Lilly's research and development efforts for tirzepatide spanned over a decade, involving extensive preclinical studies and a comprehensive clinical trial program. The SURMOUNT clinical trial series, which evaluated tirzepatide specifically for weight management in adults with obesity or overweight with weight-related comorbidities, provided the evidence base for Zepbound's approval. The company maintains manufacturing facilities that comply with FDA current Good Manufacturing Practice (cGMP) regulations to ensure consistent product quality and safety.
As the New Drug Application (NDA) holder and manufacturer of Zepbound in the United States, Eli Lilly is responsible for the medication's production, quality control, and ongoing pharmacovigilance activities. The medication is distributed through authorized wholesalers to pharmacies where eligible patients with a valid prescription can access this weight management treatment.
Zepbound (tirzepatide) is an injectable prescription medication approved for chronic weight management in adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with at least one weight-related comorbid condition such as hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease. It is administered once weekly via subcutaneous injection and is intended to be used in conjunction with a reduced-calorie diet and increased physical activity.
The medication belongs to a novel class of drugs known as dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonists. This dual mechanism of action distinguishes Zepbound from other weight management medications. Tirzepatide activates both GIP receptors and GLP-1 receptors, which are naturally occurring incretin hormones involved in glucose metabolism and appetite regulation.
The pharmacological effects of Zepbound include:
Appetite suppression through central nervous system pathways that reduce hunger and increase satiety
Delayed gastric emptying, which prolongs the feeling of fullness after meals
Improved glucose-dependent insulin secretion
Reduced glucagon secretion when blood glucose levels are elevated
These combined mechanisms contribute to reduced caloric intake and subsequent weight loss. In clinical trials, patients treated with Zepbound demonstrated substantial and sustained weight reduction compared to placebo.
Zepbound is available in multiple dose strengths (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg). Treatment begins with 2.5 mg once weekly for 4 weeks, then increases by 2.5 mg every 4 weeks until the target dose or maximum tolerated dose is reached. This gradual dose escalation helps minimize gastrointestinal side effects during treatment initiation.
If a dose is missed, patients should administer the missed dose as soon as possible if there are at least 4 days (96 hours) until the next scheduled dose. Zepbound should not be administered with other tirzepatide-containing products like Mounjaro, and it has not been studied with other GLP-1 receptor agonists. The safety and efficacy of Zepbound in pediatric patients have not been established.
The FDA approved Zepbound (tirzepatide) for chronic weight management on November 8, 2023, based on robust evidence from the SURMOUNT clinical trial program. This approval marked an important advancement in pharmacological options for obesity treatment, a condition affecting approximately 42% of US adults according to CDC data.
The pivotal evidence supporting FDA approval came from SURMOUNT-1 and SURMOUNT-2, two Phase 3, randomized, double-blind, placebo-controlled trials. SURMOUNT-1 enrolled 2,539 adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity, excluding diabetes. Participants receiving the highest approved dose (15 mg weekly) achieved a mean weight reduction of approximately 20.9% from baseline at 72 weeks, compared to 3.1% with placebo. SURMOUNT-2 specifically studied 938 adults with obesity or overweight and type 2 diabetes, demonstrating mean weight reductions of up to 15.7% with tirzepatide versus 3.2% with placebo.
Additional studies in the SURMOUNT program evaluated tirzepatide in diverse populations and clinical scenarios, including:
SURMOUNT-3: Examining additional weight loss after an initial lifestyle intervention run-in period
SURMOUNT-4: Assessing weight maintenance versus regain after withdrawal of treatment
In 2024, the FDA expanded Zepbound's indication to include treatment of adults with obesity who have obstructive sleep apnea (OSA).
The FDA's approval was contingent upon demonstrated efficacy, acceptable safety profile, and the medication's use as part of a comprehensive weight management approach. The clinical trial data showed that Zepbound also improved various cardiometabolic parameters, including blood pressure, lipid profiles, and glycemic control in patients with prediabetes or type 2 diabetes. Ongoing post-marketing surveillance and additional studies continue to evaluate long-term safety and cardiovascular outcomes.
Separately, the SYNERGY-NASH trial has evaluated tirzepatide in patients with metabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcoholic steatohepatitis (NASH).
Zepbound carries a Boxed Warning regarding the risk of thyroid C-cell tumors, the most serious safety concern identified in preclinical studies. In rodent studies, tirzepatide caused dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether Zepbound causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. The medication is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), as well as in patients with a serious hypersensitivity reaction to tirzepatide or any of the product components.
The most common adverse effects reported in clinical trials are gastrointestinal in nature and include:
Nausea (affecting up to 29% of patients at higher doses)
Diarrhea
Vomiting
Constipation
Abdominal pain
Dyspepsia
Gastroesophageal reflux disease
Eructation (belching)
Other common adverse reactions include injection site reactions, fatigue, and alopecia. Gastrointestinal effects are typically mild to moderate in severity and tend to diminish over time, particularly with gradual dose escalation. However, severe gastrointestinal adverse reactions may necessitate dose reduction or discontinuation. Zepbound is not recommended in patients with severe gastrointestinal disease, including severe gastroparesis.
Additional important warnings and precautions include:
Acute pancreatitis: Patients should be monitored for persistent severe abdominal pain, which may radiate to the back and may be accompanied by vomiting. Zepbound should be discontinued if pancreatitis is suspected.
Hypoglycemia: Risk is increased when used concomitantly with insulin or insulin secretagogues; dose reduction of these medications may be necessary.
Acute gallbladder disease: Cholelithiasis and cholecystitis have been reported; clinical evaluation is warranted if symptoms develop.
Acute kidney injury: Has been reported, primarily in association with gastrointestinal adverse reactions leading to volume depletion.
Diabetic retinopathy complications: Patients with a history of diabetic retinopathy should be monitored for progression of retinopathy.
Suicidal behavior and ideation: Although causality has not been established, patients should be monitored for depression, suicidal thoughts, or unusual mood changes.
Hypersensitivity reactions: Serious reactions including anaphylaxis and angioedema have been reported; discontinue if suspected.
Zepbound may decrease the exposure of oral contraceptives. Women using oral hormonal contraceptives should switch to a non-oral contraceptive method or add a barrier method for 4 weeks after initiating Zepbound and for 4 weeks after each dose escalation.
Patients should seek immediate medical attention if they experience symptoms of pancreatitis, severe persistent abdominal pain, signs of kidney problems (decreased urination, swelling), or allergic reactions including severe rash, itching, or difficulty breathing. Zepbound is not recommended during pregnancy, and women of reproductive potential should discontinue the medication at least 1 month before a planned pregnancy due to the long washout period.
Zepbound and Mounjaro both contain the same active ingredient, tirzepatide, but are approved for different indications. Mounjaro was approved in May 2022 for type 2 diabetes management, while Zepbound was approved in November 2023 specifically for chronic weight management in adults with obesity or overweight with weight-related conditions.
Eli Lilly's research and development efforts for tirzepatide spanned over a decade, involving extensive preclinical studies and a comprehensive clinical trial program including the SURMOUNT series that provided evidence for FDA approval.
Zepbound carries a Boxed Warning for thyroid C-cell tumors and is contraindicated in patients with personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. Other serious risks include acute pancreatitis, hypoglycemia when combined with certain diabetes medications, acute gallbladder disease, and acute kidney injury.
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