Pramlintide: research
A diabetes medicine that copies a hormone released with insulin; Symlin products are discontinued.
Also called: Symlin, SymlinPen, Pramlintide acetate, AC137, AC-0137, Tripro-amylin.
Amylin analogues · Short-acting amylin receptor agonist · Evidence: Approved drug.
51 completed, terminated or active registered studies were found; 15 planned, withdrawn or unknown-status records were excluded. Early unregistered trials make this a minimum.
Studies
- Early dose finding: 30–300 mcg. rct, n=84, Adults with type 1 diabetes. Meal glucose rises fell; the highest dose caused more nausea. (source)
- Four-week dose and meal timing. rct, n=215, People with type 1 diabetes. Several meal-based schedules improved short-term glucose markers. (source)
- Type 2 dose finding. rct, n=203, Insulin-using adults with type 2 diabetes. Short-term glucose markers improved across the tested doses. (source)
- Type 1: one year plus extension. rct, n=480, Adults with type 1 diabetes on insulin. Pramlintide modestly improved glucose control without weight gain. (source)
- Type 1: 60 and 90 mcg. rct, n=651, Adults with type 1 diabetes; mean HbA1c 8.9%. 60 mcg modestly improved HbA1c and weight over one year. (source)
- Type 1: fixed-insulin trial. rct, n=295, Adults with type 1 diabetes in label Table 6, trial 2. This fixed-insulin trial showed a modest blood sugar effect. (source)
- Type 2: 30, 75 and 150 mcg. rct, n=538, Insulin-using adults with type 2 diabetes. 150 mcg improved glucose and weight together more often than placebo. (source)
- Type 2: one-year pivotal trial. rct, n=656, Adults with type 2 diabetes using insulin, with or without oral drugs. 120 mcg twice daily produced modest sustained glucose and weight benefits. (source)
- Type 2: unpublished pivotal dataset. rct, n=499, Adults with type 2 diabetes using insulin. A pivotal 499-person dataset is described in the pooled safety report. (source)
- Type 1: slow start with insulin cuts. rct, n=296, Adults with type 1 diabetes on intensive insulin. Meal glucose and weight improved, while HbA1c fell equally with optimized insulin. (source)
- Add-on to basal insulin. rct, n=212, Adults with type 2 diabetes on insulin glargine, with or without oral drugs. Adding pramlintide to basal insulin improved glucose and weight. (source)
- Pramlintide versus mealtime insulin. rct, n=113, Adults with type 2 diabetes on basal insulin and oral drugs. Similar HbA1c control came with less weight gain and more nausea. (source)
- Single dose and food intake. crossover-rct, n=26, 11 insulin-using men with type 2 diabetes and 15 men with obesity. A single dose reduced food intake in both groups. (source)
- Low dose and food intake. crossover-rct, n=15, Healthy, normal-weight men. 30 mcg reduced meal size in healthy men. (source)
- Six-week eating study. rct, n=88, Adults with obesity; no lifestyle changes required. Lower meal sizes and daily intake accompanied modest weight loss. (source)
- Obesity: escalation to 240 mcg. rct, n=204, Adults with obesity; some had non-insulin-treated type 2 diabetes. Pramlintide produced modest weight loss without a lifestyle program. (source)
- Obesity: six dose schedules. rct, n=411, Adults with obesity receiving a lifestyle program. 120 mcg TID and 360 mcg BID helped maintain weight loss with lifestyle support. (source)
- Pramlintide plus metreleptin. rct, n=177, Adults with overweight or obesity; 177 enrolled, 139 randomized after weight-loss lead-in. Combination weight loss exceeded either drug after a selected weight-loss lead-in. (source)
- Metreleptin: larger dose-ranging trial. rct, n=636, Adults with overweight or obesity; 636 enrolled. The larger registry trial showed less weight loss than the earlier proof-of-concept report. (source)
- Metreleptin: extension to 52 weeks. rct, n=274, Completers from the 28-week combination study. Selected participants maintained weight loss through one year. (source)
- Metreleptin: trial stopped early. rct, n=213, Adults with obesity after a 6-week low-calorie-diet lead-in. The trial stopped after neutralizing activity to metreleptin was detected in a previous study. (source)
- Review of pivotal diabetes trials. systematic-review, Adults with type 1 or type 2 diabetes. Benefits were modest; long-term complications and mortality were not established. (source)
- Meta-analysis: diabetes and obesity. meta-analysis, n=1616, 930 participants with type 2 diabetes; 686 without diabetes. Pooled effects showed modest glucose and weight benefits with more nausea. (source)
- Meta-analysis: type 1 diabetes. meta-analysis, n=3297, 1,978 pramlintide and 1,319 placebo participants across 10 reported studies. The pooled direction favors small benefits with more early side effects. (source)
- Pooled heart safety. meta-analysis, n=2016, Insulin-using adults with type 2 diabetes. This pooled analysis found no increased signal for major heart events. (source)
- Metreleptin antibody follow-up. cohort, n=713, 579 metreleptin-exposed participants with obesity; 134 with lipodystrophy. Metreleptin combinations raised a separate antibody concern. (source)
- One-year real-world safety. cohort, n=1297, 766 insulin-using people with type 1 and 531 with type 2 diabetes. Severe low glucose still occurred during routine use. (source)
- Oral medicine timing. crossover-rct, n=24, Adults with type 2 diabetes. Absorption was slower, while total acetaminophen exposure was unchanged. (source)
- Mixing insulin and pramlintide. crossover-rct, n=51, Adults with type 1 diabetes. Early mixing studies do not override the label’s instruction to inject separately. (source)
- High-dose low-glucose challenge studies. rct, People with type 1 diabetes; three separate studies. Pramlintide did not blunt the measured rescue responses to induced low glucose. (source)
- Stomach emptying. crossover-rct, n=12, Six people with type 1 and six with type 2 diabetes. Both doses substantially slowed solid-food emptying. (source)
- Continuous infusion pilot. single-arm, n=11, Adults with long-standing type 1 diabetes using insulin pumps. Off-label infusion reduced glucose in a small uncontrolled pilot. (source)
- Meal dose-ratio finding. crossover-rct, Adults with type 1 diabetes. Fixed ratios reduced meal glucose rises in an acute study. (source)
- 24-hour fixed-ratio infusion. crossover-rct, Adults with type 1 diabetes. Fixed-ratio delivery reduced meal glucose rises under inpatient conditions. (source)
- Dual-hormone artificial pancreas. crossover-rct, n=28, Adults with type 1 diabetes. Rapid insulin plus pramlintide improved one-day glucose control. (source)
- Fully automated versus meal counting. crossover-rct, n=28, Adults with type 1 diabetes; 28 enrolled and 24 analyzed. Removing all meal input did not meet the trial’s non-inferiority goal. (source)
- Simple meal announcements. crossover-rct, n=32, 15 adults and 15 adolescents analyzed; 32 enrolled with type 1 diabetes. Simple meal announcements with pramlintide preserved glucose control over two weeks. (source)
- ADO09: single-meal study. crossover-rct, n=24, Adults with type 1 diabetes. A specially formulated combination reduced early meal glucose rises. (source)
- ADO09: 24-day crossover. crossover-rct, n=44, Adults with type 1 diabetes; 28 low-dose and 16 high-dose insulin users. The co-formulation improved short-term glucose patterns and weight. (source)
- ADO09: 16-week weight study. rct, n=80, Adults with type 1 diabetes. ADO09 lowered weight and mealtime insulin use versus lispro. (source)
- Outpatient automated-delivery pilot. crossover-rct, n=12, Adults with type 1 diabetes. A small supervised outpatient pilot supported further study of automated delivery. (source)
- Post-bariatric hypoglycemia. single-arm, n=20, 20 dosed adults with low glucose after bariatric surgery; 14 completed. This pilot did not improve post-bariatric low blood sugar. (source)
- GLP-1 combination: three cases. case-series, n=3, Adults with type 1 diabetes and obesity using insulin pumps. Three cases describe substantial weight loss with insulin, pramlintide and a GLP-1 drug. (source)
- Migraine provocation. crossover-rct, n=36, Adults with migraine without aura; 36 enrolled and 34 assessed. Amylin signaling can provoke migraine-like attacks in susceptible people. (source)
- Alzheimer biomarker challenge. single-arm, n=50, Older adults without diabetes, including controls and people with cognitive impairment. A single-dose biomarker study does not establish memory or dementia benefit. (source)
- Automated delivery: posted results. crossover-rct, n=33, Adults with type 1 diabetes; 33 enrolled. Posted registry results show short supervised comparisons of algorithm-driven doses. (source)
- Early intravenous proof of concept. crossover-rct, n=24, Adults with type 1 diabetes. Early infusion experiments showed an effect on glucose arriving from food. (source)
- Human amylin receptor experiments. in-vitro, Human receptor proteins expressed in laboratory cell lines. Pramlintide acts at amylin receptors built from calcitonin receptors and RAMP proteins. (source)
- Obesity: phentermine and sibutramine. rct, n=244, Adults with overweight or obesity, without diabetes; lifestyle support in all arms. Oral combinations increased weight loss and raised heart rate and diastolic pressure. (source)
- Two-week dose finding. rct, People with type 1 diabetes. Early dose finding showed activity at 30 mcg, while 10 mcg was ineffective. (source)
- Early intravenous dose finding. pk-study, People with type 1 diabetes. Early IV experiments supported a dose-dependent effect on meal glucose. (source)
- Type 1: injection timing. crossover-rct, n=40, 19 regular-insulin and 21 lispro users with type 1 diabetes. Giving pramlintide at meal start best prevented the early glucose rise. (source)
- Type 2: injection timing. crossover-rct, n=19, Adults with type 2 diabetes using lispro. At-meal dosing reduced the glucose rise more than post-meal dosing. (source)
- Alzheimer challenge: lipid markers. cohort, Adults without diabetes, with normal cognition, mild impairment or Alzheimer disease. A follow-up biomarker analysis did not test memory improvement. (source)
Pramlintide dosage
Typical reported dose: Type 1 diabetes: starts at 15 mcg before meals, up to 60 mcg
- Symlin label: type 1 diabetes: 15 mcg before each major meal, then 30 mcg before each major meal, then 45 mcg before each major meal, then 60 mcg before each major meal immediately before each major meal, under the skin. Drug label. Studied in: Adults with type 1 diabetes using mealtime insulin. (source)
- Symlin label: type 2 diabetes: 60 mcg before each major meal, then 120 mcg before each major meal immediately before each major meal, under the skin. Drug label. Studied in: Adults with type 2 diabetes using mealtime insulin. (source)
- Early trial: 30 mcg per meal: 30 mcg before each meal three times daily before meals, under the skin. Studied in a trial. Studied in: Adults with type 1 diabetes. (source)
- Early trial: 100 mcg per meal: 100 mcg before each meal three times daily before meals, under the skin. Studied in a trial. Studied in: Adults with type 1 diabetes. (source)
- Early trial: 300 mcg per meal: 300 mcg before each meal three times daily before meals, under the skin. Studied in a trial. Studied in: Adults with type 1 diabetes. (source)
- 30 mcg four times daily: 30 mcg subcutaneously four times daily four times daily, under the skin. Studied in a trial. Studied in: Insulin-using adults with type 2 diabetes. (source)
These are doses reported in labels, trials or user reports, not a personal plan. Check the source behind each one.
Pramlintide side effects and risks
Reported side effects
- Nausea: Type 1 label pool: 48% versus 17% placebo; type 2: 28% versus 12%., moderate. Persistent nausea needs clinician review; treatment may need to be reduced or stopped. (source)
- Vomiting: Type 1: 11% versus 7% placebo; type 2: 8% versus 4%., moderate. Repeated vomiting or inability to eat needs prompt review of fluids, glucose and insulin. (source)
- Appetite loss: Type 1: 17% versus 2% placebo; type 2: 9% versus 2%., moderate. Eating less changes mealtime insulin needs; monitor intake and glucose together. (source)
- Headache: Type 2 label pool: 13% versus 7% placebo., mild. Check glucose; persistent or severe headache needs assessment. (source)
- Severe low blood sugar with insulin: Type 1, first 3 months without an initial insulin cut: medically assisted events in 7.3% versus 3.3% placebo., serious. Starting treatment requires your clinician to reduce mealtime insulin, with frequent blood sugar checks. (source)
- Stomach pain: Type 2: 8% versus 7% placebo., moderate. Severe or persistent pain needs prompt assessment, especially with vomiting. (source)
- Fatigue: Type 1 and type 2 label pools: 7% versus 4% placebo., mild (source)
- Dizziness: Type 1: 5% versus 4% placebo; type 2: 6% versus 4%., moderate. Check glucose and avoid driving while symptoms persist. (source)
- Injection-site reactions: Postmarketing reports; frequency cannot be estimated., mild. Use room-temperature solution, rotate sites and check injection technique. (source)
- Pancreatitis: Reported after approval; frequency and causation are uncertain., serious. Severe persistent upper-abdominal pain, especially with vomiting, needs urgent assessment. (source)
Stop and get help if
- Confusion, seizure, fainting, or low blood sugar that does not recover: Follow your prescribed rescue plan. Call emergency services for severe symptoms or failure to recover.
- Severe persistent upper-belly pain, especially with vomiting: Stop pramlintide and seek urgent care for possible pancreatitis.
- Swollen face or throat, trouble breathing, or widespread hives: Stop the injection and seek emergency care.
- Repeated vomiting or inability to keep down food or fluids: Get urgent help with blood sugar, fluids and insulin. Do not inject pramlintide if you cannot eat.
Who should avoid it
- under18: Pediatric safety and effectiveness are not established; the label advises against pediatric use.
- pregnant: Human safety data are limited; rat studies found birth defects at high exposures.
- breastfeeding: Transfer into human milk, infant effects and milk production are unknown.
- tryingToConceive: Plan diabetes care with your clinician before pregnancy.
- gastroparesis: The label rules out use with gastroparesis, meaning slow stomach emptying. Pramlintide slows it further.
- other: The label rules out use if you cannot feel low blood sugar warning signs.
- other: Avoid after severe low blood sugar needing help within the past 6 months, or when episodes recur.
- other: The label rules out use after a serious allergy to pramlintide or any ingredient.
- other: The label excludes people with HbA1c above 9%, unreliable glucose checks or inability to follow insulin adjustments. HbA1c measures long-term blood sugar.
- eatingDisorderHistory: Appetite loss and nausea may worsen restrictive eating; this is not a label contraindication.
- pancreatitisHistory: Pancreatitis has been reported after approval; prior pancreatitis needs review before use.
- kidneyDisease: Kidney disease needs clinician review. No label dose change for creatinine clearance 15–89 mL/min. End-stage kidney disease has not been studied.
- liverDisease: Liver impairment has not been studied.
- surgeryPlanned: Fasting and illness affect dosing and insulin needs. If interrupted, the label requires restarting the initiation schedule.
- other: Visual or hand-function problems can cause dosing errors; the label calls for extra caution.
- other: Migraine-like attacks occurred in an IV provocation study. The risk with routine SC doses is not established.
- diabetes: Pramlintide supplements insulin; it cannot replace it. Mealtime insulin must be adjusted with close glucose monitoring.
- testedAthlete: No pramlintide-specific 2026 ruling was found. Confirm with the sport’s anti-doping body; accompanying insulin is prohibited.
- other: The label excludes people who need medicines that stimulate gut movement.
Interactions
- Insulin: Severe low blood sugar risk rises. When starting pramlintide, your clinician must reduce mealtime insulin and plan blood sugar checks. Inject separately; never mix.
- Sulfonylureas and meglitinides: These increase insulin release and can add to low-glucose risk; reassess the glucose-lowering plan.
- Time-sensitive oral medicines: For medicines needing rapid or threshold absorption, the label says at least 1 hour before or 2 hours after pramlintide.
- Warfarin and other critical oral medicines: Stomach emptying is delayed. No specific warfarin interaction trial was found; review timing and condition-specific monitoring.
- Medicines changing gut movement: The label advises against use with drugs that change gut movement or slow nutrient absorption.
- GLP-1 and GIP/GLP-1 drugs: Fullness and delayed stomach emptying may add up. 3 cases with type 1 diabetes and obesity leave combination safety uncertain.
- Other amylin agonists: Shared amylin effects may add nausea and slow stomach emptying. Cell studies do not establish combination safety.
- Drugs that increase low-glucose risk: These medicines can raise low blood sugar risk when taken together.
- Drugs that mask low-glucose symptoms: These can hide low blood sugar warning signs.
- Metreleptin: Obesity trials tested this pair, but neutralizing leptin antibodies raised concern. The combination has no obesity approval.
Product quality risks
- No independent study testing online pramlintide products or counterfeit Symlin pens was located.
- Other online peptide tests show why identity, content and contamination matter; those rates cannot be assigned to pramlintide.
- In three online semaglutide samples, purity was 7–14% and content 29–39% above the label; one contained elevated endotoxin. This was not pramlintide.
- FDA warns that poor compounding can cause contamination or too much or too little active drug.
- A research-use label and an HPLC purity number do not establish an injectable product’s sterility or dose.
How Pramlintide works
It copies amylin, a hormone released with insulin after meals. It slows food leaving the stomach, reduces the liver’s meal-related sugar signal and helps you feel full. Its short action is why Symlin is injected before meals.
- Amylin receptors, AMY1–AMY3: Signals through calcitonin receptors paired with RAMP proteins.
- Meal-related glucagon release: Reduces the signal telling the liver to release sugar after eating.
- Stomach emptying and fullness: Slows food delivery to the gut and reduces meal size.
Half-life: About 48 minutes in healthy adults; label dose studies show 48–55 minutes.
Gaps: Long-term effects on death, heart events, kidney damage and diabetes complications are not established. Modern combinations with semaglutide or tirzepatide lack large randomized pramlintide trials. Community prevalence is unknown; small forum counts are not estimates of all users. No reliable non-seller source established powder vial sizes, water volumes, microdosing or cycling. The highest obesity dose here is 360 mcg BID or TID. Older brief safety studies used higher doses; this is not a general safety ceiling. Exact schedules and all arm-level outcomes remain unavailable for some old or unpublished trials. WADA, UK authorisation and Australian scheduling need further drug-specific confirmation. No independent online pramlintide quality survey or compound-specific poison-center series was located. Pramlintide and cagrilintide have separate dose evidence. No validated dose-conversion or head-to-head replacement schedule was found.
Related to Pramlintide
- Cagrilintide: An unapproved weekly amylin analogue with weight-loss trials and common stomach symptoms.
- CagriSema: An unapproved cagrilintide–semaglutide combination with phase 3 weight-loss and diabetes results.
- Semaglutide: A GLP-1 medicine with strong weight, glucose, heart and kidney evidence; dose and formulation matter.
- Dulaglutide: A weekly GLP-1 medicine approved for type 2 diabetes and lower heart-event risk.
Pramlintide: the short version
Sources
- 21 CFR 216.23 — Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act., Office of the Federal Register · eCFR · 2026
- 503B Bulk Drug Substances List, FDA · FDA · 2026
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, FDA · FDA · 2026
- Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act, FDA · FDA · 2026
- Compounding and the FDA: Questions and Answers, FDA · FDA · 2026
- Download medicine data, European Medicines Agency · European Medicines Agency · 2026
- MHRA Products | Home, MHRA · MHRA · 2026
- The 2026 Prohibited List, World Anti-Doping Agency · WADA · 2026
- Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026, Australian Government · Australian Government · 2026
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act, FDA · FDA · 2025
- Anaphylaxis, NHS · NHS · 2023
- Australian Register of Therapeutic Goods (ARTG), Therapeutic Goods Administration · TGA
- Drug Product Database: Access the database, Health Canada · Health Canada
- Drugs@FDA: SYMLIN, NDA 021332, FDA
- FD&C Act Provisions that Apply to Human Drug Compounding, FDA · FDA
Sources checked: 2026-10-18.
Information only, not medical advice. Peptifacts does not sell anything and does not link to sellers.