Approved drugOral PCSK9 inhibitor (macrocyclic peptide)

Enlicitide

Lipfendra, MK-0616, enlicitide decanoate

Common dose: 20 mg once daily
Cycle: Continuous
Form: 20 mg tablets

A ring-shaped (macrocyclic) peptide taken as a daily pill that blocks PCSK9, a liver protein that destroys LDL receptors. More receptors stay on liver cells and pull LDL (“bad”) cholesterol out of the blood.

Evidence. FDA-approved on July 15, 2026 as Lipfendra, the first PCSK9 inhibitor taken as a pill, to lower LDL cholesterol in adults, including those with inherited (familial) high cholesterol. In CORALreef Lipids (2,904 adults, 97% on statins), LDL fell 57% vs a 3% rise on placebo at 24 weeks; whether it prevents heart attacks and strokes is being tested in a 14,550-person outcomes trial. Under EU review since March 2026 and not approved elsewhere as of early October 2026.

What it’s used for

Approved uses first, then uses tested in people, then claims that rest on animal studies or user reports.

High LDL cholesterol: LabelApproved for adults, with diet and exercise, usually on top of a statin. In CORALreef Lipids (2,904 adults), LDL fell 57% vs a 3% rise on placebo at 24 weeks.
Inherited high cholesterol (HeFH): LabelCovered by the approval. In 303 adults already on statins, 64% also on ezetimibe, LDL fell 58.2% vs a 2.6% rise on placebo at 24 weeks.
Compared with other cholesterol pills: TrialPositive: over 8 weeks in 301 adults on statins, LDL fell 64.6% vs 27.8% with ezetimibe, 6.3% with bempedoic acid and 36.5% with both.
Lowering lipoprotein(a): TrialModest: in the HeFH trial, lipoprotein(a), an inherited heart-risk particle, fell a median 24.7% vs 1.6% on placebo. Whether that lowers heart risk is unknown.
Preventing heart attacks and strokes: No studyUnproven so far: CORALreef Outcomes, in about 14,550 high-risk adults, is under way. The label notes that lowering LDL cut such events in trials of statins and injected PCSK9 drugs.
Inherited high cholesterol in children: No studyNot yet known: a phase 2/3 trial in children and teens with HeFH began in 2025, and it isn’t approved under 18.

Label: an approved use. Trial: tested in people, with the result. No study: nothing published supports it.

Every compound’s uses, by body system: evidence map, and by condition: conditions A to Z.

Status

Approval: Approved in the US on July 15, 2026 as Lipfendra 20 mg tablets, with diet and exercise, to lower LDL cholesterol in adults with high cholesterol, including heterozygous familial hypercholesterolemia (HeFH); FDA had granted it a national priority voucher in December 2025. Not approved elsewhere as of early October 2026; under EU review since March 2026.
Approval history: 2026US FDA: Lipfendra: lowers LDL cholesterol in adults, including inherited (familial) forms
European Union: No marketing authorization yet; the EMA has been evaluating an application for adults with high cholesterol or mixed dyslipidemia since March 2026.
United Kingdom: No marketing authorization; no UK product information is listed (October 2026).
Canada: No marketing authorization; Health Canada’s Drug Product Database lists no enlicitide product.
Australia: No product registered; the TGA lists no product information for enlicitide.
Sport (WADA 2026): Not banned in sportNot named on the 2026 list, and cholesterol-lowering drugs aren’t in any banned class; S0 doesn’t apply to an approved drug.

Sport status follows the WADA Prohibited List in force since January 1, 2026; athletes should confirm with their anti-doping organization. Checked October 5, 2026. Status outside the US checked October 7, 2026 against EMA, MHRA, Health Canada and TGA records. By country: EU, UK, Canada, Australia. Status of every compound.

How it works

LabelBased on the product label.

Not known

Whether it lowers heart attacks, strokes or deaths is unknown until CORALreef Outcomes (about 14,550 people) reports, expected around 2029. Effects beyond about 2 years, and in children, are unknown.

Protocol

Label

Lipfendra

20 mg once daily, in the morning on an empty stomach with water, black coffee or plain tea; swallowed whole, with no food or other drinks for 30 minutes.

Trial

Ballantyne 2023

6, 12, 18 or 30 mg once daily for 8 weeks lowered LDL 41.2–60.9% more than placebo; 20 mg went on to phase 3.

Frequency: Once daily
Route: By mouth (tablet), fasting
Timing: Morning, on an empty stomach; nothing but water, black coffee or plain tea for 30 minutes after.
Cycle: Continuous. The label treats it as long-term therapy, not a cycle.
Continuous, shown over 26 weeks

Common protocols

The ways Enlicitide is most often run, each tagged with where it comes from.

Lipfendra

Label

Dose: 20 mg
How often: Once daily
How long: Long-term

Morning, on an empty stomach with water, black coffee or plain tea; no food or other drinks for 30 minutes. LDL can be checked from 4 weeks.

Phase 2b dose range

Trial

Dose: 6, 12, 18 or 30 mg
How often: Once daily
How long: 8 weeks

LDL fell 41.2%, 55.7%, 59.1% and 60.9% more than placebo. The label says 20 mg gives near-maximal LDL lowering (Ballantyne 2023).

Added to statins and ezetimibe

Trial

Dose: 20 mg
How often: Once daily
How long: 52 weeks

97% in CORALreef Lipids took a statin, and 64% in the HeFH trial also took ezetimibe; LDL still fell 56–59% more than placebo at 24 weeks.

Taking it

Where it goes

By mouth each morning on an empty stomach with water, black coffee or plain tea, swallowed whole (not split, crushed or chewed); no food or other drinks for 30 minutes. Other medicines can be taken at the same time (label).

If you miss a dose

Lipfendra label: take it as soon as possible, at least 30 minutes before the next food or drink other than water, black coffee or plain tea. Never take 2 doses in one day.

Missed doses for every compound

What to expect

First week
Blood levels reach steady state in about 7 days.
Label
From week 4
The LDL drop can be measured as early as 4 weeks after starting.
Label
Week 24
LDL fell 57% vs a 3% rise on placebo in CORALreef Lipids and 58% vs a 3% rise in the HeFH trial; non-HDL cholesterol and apoB fell about 50%.
Label
Week 52
In the HeFH trial, LDL stayed 55.3% below baseline vs an 8.7% rise on placebo.
Trial

Side effects and what to do

Diarrhea (label: 7% vs 2% on placebo in the HeFH trial)

Report it if it’s severe or doesn’t settle.

Dizziness (label: 9% vs 4% on placebo in the HeFH trial)

Report it if it’s frequent or severe.

Side effects overall (label: similar to placebo in the 2,904-person trial, with similar rates of stopping)

The label has no warnings section; anything new is worth reporting to the prescriber.

Stop and get medical help

The label gives no stop rules except for pregnancy: stop once it’s recognized unless the benefits outweigh the risks. Face or throat swelling or trouble breathing needs emergency care.

Can it cause …?

The side effects people ask about most, answered one by one. Each answer says where it comes from.

Tiredness: Not reportedFatigue isn’t listed in the label; side effects overall were similar to placebo in the 52-week trial of 2,904 adults.
Headache: Not reportedHeadache isn’t listed in the label; in the 52-week trials (about 3,200 adults), side effects overall matched placebo.
Nausea or vomiting: Not reportedNausea isn’t listed in the label; side effects overall matched placebo in the 2,904-person, 52-week trial.
Diarrhea or constipation: LabelDiarrhea: 7% vs 2% on placebo in the 303-person HeFH trial. In the larger 2,904-person trial, side effects overall matched placebo.
Dizziness: LabelDizziness: 9% vs 4% on placebo in the 303-person HeFH trial. In the 2,904-person trial, side effects overall matched placebo.
Trouble sleeping: Not reportedTrouble sleeping isn’t listed in the label (52-week trials in about 3,200 adults).
Hair loss: Not reportedHair loss isn’t listed in the label (52-week trials in about 3,200 adults).
Acne, rash or skin changes: Not reportedRash or skin changes aren’t listed in the label. As a pill, it causes no injection-site reactions.
Water retention or swelling: Not reportedFluid retention or swelling isn’t listed in the label (52-week trials in about 3,200 adults).
Joint or muscle pain: Not reportedJoint or muscle pain isn’t listed in the label (52-week trials in about 3,200 adults, nearly all also on statins).
Anxiety, low mood or irritability: Not reportedAnxiety or low mood isn’t listed in the label (52-week trials in about 3,200 adults).
Low or high blood sugar: Not reportedBlood sugar changes aren’t listed in the label; half of the 2,904 people in the main trial had diabetes.
Fast heartbeat or blood pressure changes: LabelNo heart rhythm effect: QT wasn’t meaningfully prolonged at 4 times the usual peak level. Effects on heart attacks and strokes are still being studied.
More hunger: Not reportedAppetite changes aren’t listed in the label (52-week trials in about 3,200 adults).
Liver strain: LabelLiver problems aren’t a listed side effect. Moderate liver impairment didn’t change its levels; it hasn’t been studied in severe impairment.
Kidney problems: LabelNot a listed side effect. The kidneys clear most of it, but even dialysis raised levels too little to need a dose change, per the label.
Cancer risk: LabelNo tumors in a 26-week study in cancer-prone mice at 59 times human exposure; the label says it isn’t expected to cause cancer in people.

Label: from the prescribing information. Not reported: studied in people and not reported. A side effect that hasn’t been reported can still happen, especially with long or high-dose use. Any of these across every compound: the side-effect finder.

Who should avoid it

What its label rules out or warns about, most important first.

Pregnancy: LabelThe label says to stop once pregnancy is recognized unless the benefits outweigh the risks, since lowering cholesterol may harm a fetus. It crossed the placenta in rats.
Breastfeeding: LabelNo human data; low levels reached nursing rat pups. The label weighs breastfeeding’s benefits against the mother’s need for the drug and possible risks to the baby.
Children and teens: LabelSafety and effectiveness aren’t established under 18; a trial in children and teens with inherited high cholesterol is under way.
Severe liver disease: LabelNot studied in severe liver impairment (Child-Pugh C); moderate impairment didn’t change its levels.

Interactions

Only interactions stated on a product label or measured in a human study are listed.

Food and drinks other than water, black coffee or plain tea: LabelTaken 30 minutes after a meal, enlicitide exposure fell 48% (peak level 50%). The label says to take it fasting and wait 30 minutes before eating.
Other oral medicines (lithium, levothyroxine, digoxin, warfarin, atorvastatin, alendronate, lisinopril): LabelStudied with enlicitide and its absorption enhancer: none of their levels changed, and atorvastatin didn’t change enlicitide’s. The label says it can be taken with other medicines.
Oral semaglutide tablets: LabelNeither changed the other’s levels in a study, though both tablets carry absorption enhancers.

Label: a product label rules it out, warns about it or lists the interaction. This isn’t a complete list: a pharmacist or doctor can check a specific medicine or condition. Every documented interaction, by medicine: drug interactions.

Special situations

What the label and studies say about pregnancy, breastfeeding, kidney and liver problems, age and surgery.

Pregnancy: LabelThe label says to stop once pregnancy is recognized unless the benefit outweighs the risk, since lowering cholesterol may harm a fetus. Rat and rabbit studies showed no harm; it crossed the rat placenta.
Breastfeeding: LabelNo human data. It reached nursing rat pups at low levels. The label weighs breastfeeding’s benefits against the mother’s need for the drug and possible risks.
Kidney problems: LabelNo dose change: severe impairment is expected to raise levels about 26%, and dialysis raised them up to 75%, changes the label calls not clinically meaningful.
Liver problems: LabelNo change with moderate liver impairment (Child-Pugh B); not studied in severe impairment (Child-Pugh C).
Older adults: LabelOf 2,137 people on it in placebo-controlled trials, 45% were 65 or older and 12% were 75 or older; no overall differences in safety or effectiveness.
Children and teens: LabelNot approved under 18; safety and effectiveness aren’t established. A trial in children and teens with inherited high cholesterol (HeFH) is recruiting.
Surgery and anesthesia: PrecautionNo data; tell the surgical team about it, as with any medicine. It is a fasting morning tablet, so doses around surgery need planning.

Label: what the prescribing information says. Precaution: not studied, so the caution follows from how it works or from a related drug. Ages are given as approved or studied; this site never gives doses for children. Across every compound: pregnancy, breastfeeding, kidney disease, liver disease, older adults and surgery.

Tracking and pairing

Worth tracking

LDL cholesterol, from about 4 weeks
Non-HDL cholesterol and apoB
Pregnancy plans

Often paired with

Usually run on its own.

Human studies

4 key published human studies, with how many people took part. Animal studies aren’t listed here.

20262,909 people

LDL fell 57.1% vs a 3.0% rise on placebo at 24 weeks (difference 55.8 points), with significant drops in non-HDL cholesterol, apoB and lipoprotein(a); adverse events didn’t appear to differ.

Design
Randomized double-blind placebo-controlled trial (phase 3) in adults with, or at risk of, atherosclerotic heart disease
Dose
20 mg once daily
Length
52 weeks

Navar et al., N Engl J Med 2026 (CORALreef Lipids), PMID 41879224
2026303 people

LDL fell 58.2% vs a 2.6% rise on placebo at 24 weeks and 55.3% vs an 8.7% rise at 52 weeks; lipoprotein(a) fell a median 24.7% vs 1.6%.

Design
Randomized double-blind placebo-controlled trial (phase 3) in heterozygous familial hypercholesterolemia
Dose
20 mg once daily, on top of statins
Length
52 weeks

Ballantyne et al., JAMA 2026 (CORALreef HeFH), PMID 41206969
2026301 people

LDL fell 64.6% vs 6.3% with bempedoic acid, 27.8% with ezetimibe and 36.5% with both; side effects were similar across groups.

Design
Randomized double-blind active-comparator trial (phase 3) in adults on statins
Dose
20 mg once daily vs bempedoic acid, ezetimibe or both
Length
8 weeks

Catapano et al., J Am Coll Cardiol 2026 (CORALreef AddOn), PMID 42017875
2023381 people

LDL fell 41.2% to 60.9% more than placebo depending on dose; adverse events 39.5–43.4% vs 44.0% on placebo.

Design
Randomized double-blind placebo-controlled dose-ranging trial (phase 2b)
Dose
6, 12, 18 or 30 mg once daily
Length
8 weeks, plus 8 weeks of follow-up

Ballantyne et al., J Am Coll Cardiol 2023, PMID 36889610

All human studies on Vial Guide

Trials under way

Registered trials that are still running, or that finished without published results, most important first. Checked on ClinicalTrials.gov, October 7, 2026.

Phase 3NCT06008756
CORALreef Outcomes: enlicitide vs placebo in about 14,550 adults at high heart risk: time to heart death, heart attack, stroke and other major heart events
Active, not recruiting; primary completion expected November 2029
Phase 3NCT06492291
CORALreef Extension: open-label enlicitide for about 3,000 adults who finished the Lipids, HeFH or AddOn trials: long-term safety
Active, not recruiting; completion expected October 2028
Phase 3NCT07216482
Enlicitide plus rosuvastatin vs placebo in 996 adults with high cholesterol: change in LDL at 8 weeks
Active, not recruiting; main data collected August 2026, completion expected November 2026
Phase 2/3NCT07058077
Enlicitide vs placebo in about 153 children and teens with HeFH: drug levels, LDL change and safety
Recruiting since August 2025; completion expected 2037
Phase 2NCT07614984
MK-7262, an experimental lipoprotein(a)-lowering drug, alone and with enlicitide in about 750 adults with high lipoprotein(a)
Recruiting since June 2026; completion expected October 2027

Every compound’s registered trials: trials under way.

Limits of the evidence

Approval rests on LDL cholesterol, a lab marker: two 52-week trials in about 3,200 adults, plus an 8-week comparison with ezetimibe and bempedoic acid. Whether it prevents heart attacks, strokes or deaths is being tested in CORALreef Outcomes (about 14,550 people). Almost everyone was also on a statin; it hasn’t been compared head to head with injected PCSK9 drugs, and safety beyond about 2 years, in children and in severe liver disease is unknown.

How it’s supplied

Film-coated tablets, swallowed whole once a day on an empty stomach, in 20 mg strengths. Taken by mouth, so there’s nothing to mix or draw up, and the calculator and dose log don’t apply.

Datasheet

Half-life: about 14 hours (effective) LabelWith 20 mg tablets once daily in adults with high cholesterol; steady state in about 7 days. A slow final phase gives a terminal half-life of about 244 hours (about 10 days).
Type: Peptide, 8 amino acids
Molecular weight: 1550.8 g/mol (enlicitide cation); 1722.1 as the decanoate salt
Formula: C₈₂H₁₁₀FN₁₄O₁₅ (cation); C₉₂H₁₂₉FN₁₄O₁₇ (decanoate)
Sequence: A-(D-Dap)-(F*)-(5-F-W)-(3-OH-P)-T-(O-Me-Y)-(2-Me-P), closed into three rings: two lactam bridges through a linker on the tryptophan, and an ether bridge from the modified phenylalanineF*) to the hydroxyproline; the D-Dap (diaminopropionic acid) carries a trimethylammonium tail
Storage before use: Tablets in a bottle with a desiccant and a child-resistant cap. Store at 20–25 °C; excursions to 15–30 °C are allowed.
After mixing or opening: Nothing to mix. Keep in the original bottle, tightly closed, with the desiccant inside to protect from moisture.

Half-life: Lipfendra prescribing information (July 2026), section 12.3
Molecule: Lipfendra label, section 11 (decanoate formula and MW 1722.12; 20 mg enlicitide = 22.21 mg decanoate); FDA GSRS systematic name (UNII R7EZ772VG2); PubChem CID 164933665 and 172866837
Storage: Label Lipfendra prescribing information (July 2026), section 16, and Patient Information

Every compound side by side: the half-life chart and the storage chart.

Identifiers

UNII (FDA): R7EZ772VG2; PSR59MCX5M (decanoate)
PubChem CID: 164933665; 172866837 (decanoate)
DrugBank: DB22580
ATC code: Not yet assigned
CAS number: 2407527-14-2 (enlicitide); 2861205-06-1 (decanoate)
Development codes: MK-0616 (Merck); some early studies used enlicitide chloride
Brand names: Lipfendra (US)
First described: Discovered at Merck by mRNA display screening; first described in 2023. First approved: US, July 2026.

Every compound’s numbers: the identifiers table.

Product form and quality

Tablets hold enlicitide decanoate with sodium caprate, an absorption enhancer: 20 mg enlicitide equals 22.21 mg of the salt. Some early studies used enlicitide chloride. Only about 1% is absorbed, and a meal beforehand nearly halves exposure.

Cautions

No boxed warning, contraindications or warnings section in the label; side effects overall in the 2,904-person trial were similar to placebo.
Must be taken fasting: a dose taken 30 minutes after a meal cut exposure by 48%, so food waits at least 30 minutes after the tablet.
Diarrhea (7% vs 2%) and dizziness (9% vs 4%) were more common than on placebo in the 303-person HeFH trial.
Pregnancy: the label says to stop once pregnancy is recognized unless the benefits outweigh the risks.
Not yet shown to prevent heart attacks or strokes; the outcomes trial (about 14,550 people) runs to about 2029.

Questions

What is enlicitide?

How does enlicitide work?

Enlicitide is a ring-shaped (macrocyclic) peptide that binds PCSK9, a protein that latches onto LDL receptors on liver cells and sends them to be destroyed. Blocking PCSK9 leaves more receptors to pull LDL (“bad”) cholesterol out of the blood. A single dose in the range used in the trials cuts free PCSK9 in the blood by over 90%. Only about 1% of each dose is absorbed, helped by sodium caprate, an absorption enhancer in the tablet. Whether it lowers heart attacks, strokes or deaths is unknown until CORALreef Outcomes (about 14,550 people) reports, expected around 2029. Effects beyond about 2 years, and in children, are unknown.

Is enlicitide FDA-approved?

Approved in the US on July 15, 2026 as Lipfendra 20 mg tablets, with diet and exercise, to lower LDL cholesterol in adults with high cholesterol, including heterozygous familial hypercholesterolemia (HeFH); FDA had granted it a national priority voucher in December 2025. Not approved elsewhere as of early October 2026; under EU review since March 2026.

What is the usual enlicitide dose?

From the label (Lipfendra): 20 mg once daily, in the morning on an empty stomach with water, black coffee or plain tea; swallowed whole, with no food or other drinks for 30 minutes. From human studies (Ballantyne 2023): 6, 12, 18 or 30 mg once daily for 8 weeks lowered LDL 41.2–60.9% more than placebo; 20 mg went on to phase 3. These are the amounts sources reference, not recommendations.

How is enlicitide taken?

By mouth: film-coated tablets, swallowed whole once a day on an empty stomach. Morning, on an empty stomach; nothing but water, black coffee or plain tea for 30 minutes after. There’s nothing to mix or measure with a syringe.

Who should avoid enlicitide?

Pregnancy: The label says to stop once pregnancy is recognized unless the benefits outweigh the risks, since lowering cholesterol may harm a fetus. It crossed the placenta in rats. Breastfeeding: No human data; low levels reached nursing rat pups. The label weighs breastfeeding’s benefits against the mother’s need for the drug and possible risks to the baby. Children and teens: Safety and effectiveness aren’t established under 18; a trial in children and teens with inherited high cholesterol is under way. The “Who should avoid it” section lists 1 more group and 3 interactions.

What is the half-life of enlicitide?

About 14 hours (effective), according to the prescribing information. With 20 mg tablets once daily in adults with high cholesterol; steady state in about 7 days. A slow final phase gives a terminal half-life of about 244 hours (about 10 days).

How should enlicitide be stored?

Before mixing: Tablets in a bottle with a desiccant and a child-resistant cap. Store at 20–25 °C; excursions to 15–30 °C are allowed. Nothing to mix. Keep in the original bottle, tightly closed, with the desiccant inside to protect from moisture.

Is enlicitide banned in sport?

No. Not named on the 2026 list, and cholesterol-lowering drugs aren’t in any banned class; S0 doesn’t apply to an approved drug.

Has enlicitide been studied in people?

Yes. The human studies section lists 4 published studies. The largest, from 2026, included 2,909 people. LDL fell 57.1% vs a 3.0% rise on placebo at 24 weeks (difference 55.8 points), with significant drops in non-HDL cholesterol, apoB and lipoprotein(a); adverse events didn’t appear to differ.

How long has enlicitide been studied in people?

Trial 52 weeks in placebo-controlled trials (2,137 people on enlicitide); an open-label extension runs to 2028, and the 14,550-person outcomes trial to about 2031.

Does enlicitide come in other forms, like a pill or nasal spray?

Label A once-daily tablet; only about 1% is absorbed, helped by sodium caprate in the tablet. Animal safety studies gave it by injection. Injected PCSK9 drugs, such as evolocumab, are different molecules.

Can you drink alcohol while taking enlicitide?

Label The label doesn’t address alcohol. It is taken fasting with only water, black coffee or plain tea, then nothing else to drink for 30 minutes.

Can enlicitide be taken with semaglutide or tirzepatide?

Label No interaction found: in a study, enlicitide and oral semaglutide tablets didn’t change each other’s levels. No trial has tested combined effects on weight or heart outcomes.

What happens if you take too much enlicitide?

Label The label lists no overdose cases and no specific treatment, and advises contacting Poison Help (1-800-222-1222) or a toxicologist. Call emergency services for severe symptoms.

Sources

Lipfendra (enlicitide) prescribing information, July 2026 (Merck Sharp & Dohme, DailyMed)
Drugs@FDA: Lipfendra (NDA 220848), approved July 15, 2026 (priority review)
FDA: national priority vouchers granted for enlicitide decanoate and sacituzumab tirumotecan (December 19, 2025)
Navar et al., CORALreef Lipids trial (NEJM 2026) PMID 41879224
Ballantyne et al., CORALreef HeFH trial (JAMA 2026) PMID 41206969

For the protocol details

Lipfendra prescribing information, July 2026, sections 2, 6, 8, 12 and 14 (DailyMed)
Catapano et al., CORALreef AddOn trial vs oral nonstatin drugs (J Am Coll Cardiol 2026) PMID 42017875
Ballantyne et al., phase 2b trial of MK-0616 (J Am Coll Cardiol 2023) PMID 36889610

For how it works, who should avoid it and the limits of the evidence

Lipfendra prescribing information, sections 4, 8, 12 and 14 (Merck Sharp & Dohme, DailyMed, July 2026)
CORALreef Outcomes, enlicitide vs placebo in about 14,550 adults at high heart risk (US trial registry entry) NCT06008756

For uses, the side-effect questions, special situations, trials, identifiers and status outside the US

Lipfendra (enlicitide) prescribing information and Patient Information, sections 1, 2, 6, 8, 10, 11, 12, 13 and 14 (Merck Sharp & Dohme, DailyMed, July 2026)
Drugs@FDA: Lipfendra (NDA 220848), approved July 15, 2026
EMA: applications for new human medicines under evaluation, September 2026 (enlicitide, evaluation started March 2026)
Johns et al., discovery and phase 1 studies of the oral macrocyclic peptide MK-0616 (Circulation 2023) PMID 37125593
FDA Global Substance Registration System records, DrugBank entry DB22580 and WHO ATC index (no entry), checked October 2026
Health Canada Drug Product Database, UK electronic medicines compendium and TGA product information search (checked October 8, 2026)
ClinicalTrials.gov registry entries for the trials listed (checked October 8, 2026)

By Vial Guide editorsLast reviewed October 7, 2026

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