Insulin Icodec (Awiqli)_Dosage, benefits & legal status
Also known as Awiqli, insulin icodec-abae, icodec
One injection a week, and a half-life that really does last one.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Insulin Icodec (Awiqli)?
Plain language first. The technical label stays, but it never stands alone.Overview
This is a basal insulin taken once a week instead of once a day, and it is the first of its kind sold in the United States. Two things matter more than the convenience. The first is that it is approved for type 2 diabetes only. The FDA's advisory committee voted 7 to 4 against recommending it for type 1, because the trial in type 1 showed roughly double the rate of serious low blood sugar compared with a daily insulin. The second is the pen. It holds 700 units per milliliter, seven times the concentration of a standard insulin pen, so a measuring error carries seven times the consequence and cannot be undone for days.
Insulin icodec is a once-weekly basal insulin analog. Its label gives three substitutions to the human insulin sequence, Tyr(A14) to Glu and Tyr(B16) and Phe(B25) both to His, with the threonine at B30 omitted, and a fatty-acid side chain attached at Lys(B29) that binds reversibly to albumin and holds the molecule in circulation. The formula is C280H435N71O87S6 and the molecular weight 6,380.26 daltons. The label states a half-life of approximately one week, independent of dose. It is supplied as a U-700 pen, seven times the strength of ordinary U-100 insulin, and the approved indication is an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
What it's used for
As an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes. It is not approved in the United States for type 1 diabetes.
How does Insulin Icodec (Awiqli) work?
What it does in the body, and where.A weekly insulin has to solve one problem: stay in the bloodstream for seven days without releasing too much of itself at any moment. Icodec does it by clinging to albumin.
- 01Three substitutions and a missing residueHuman insulin is two chains, A and B, held together by disulfide bonds. The label lists the changes: tyrosine at A14 becomes glutamate, tyrosine at B16 and phenylalanine at B25 both become histidine, and the threonine at B30 is deleted. Those changes lower the molecule's affinity for its own receptor and make it far more stable, and that is the trade a weekly insulin has to make.
- 02A fatty chain that holds onto albuminA fatty-acid side chain is attached at lysine B29. It binds reversibly to albumin, the most abundant protein in blood, so the great majority of the injected dose is parked on a carrier rather than free to act. Only the small unbound fraction reaches insulin receptors at any moment. The carrier is what converts a drug that would otherwise last hours into one with a half-life of about a week.
- 03Why the half-life really is a week, unlike some weekly drugsThe label states the half-life as approximately one week, independent of dose. That is worth noting, because weekly dosing does not always mean a week-long drug. The three once-weekly growth hormones on this site are given weekly despite half-lives between about 25 hours and 3 days. With icodec the schedule follows the pharmacology, and the consequence cuts both ways: a dose given in error is still being cleared a week later.
- 04Where the type 1 problem comes fromIn type 2 diabetes the body still makes some insulin of its own, and that absorbs a certain amount of mismatch between a flat weekly drug level and a fluctuating daily need. In type 1 there is no such buffer. The pivotal type 1 trial found clinically significant or severe low blood sugar at roughly 1.9 times the rate seen with daily degludec, and reporting from the advisory committee describes the excess clustering in the middle of the weekly cycle. That is the mechanism behind the regulatory split between the United States and everywhere else.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
What it is approved for, and what it is not
FDA-approved- RegulatoryApproved in the United States as an adjunct to diet and exercise for adults with type 2 diabetes. The label mentions type 2 only; we found no type 1 reference in it.
- RegulatoryThe FDA advisory committee voted 7 to 4 against recommending it for adults with type 1 diabetes in May 2024.
- RegulatoryThe European Union, Canada and Australia authorized it for diabetes in adults without excluding type 1, so the same molecule carries a broader indication outside the United States.
The hypoglycemia signal in type 1
FDA-approved- Human trialIn the 582-person type 1 trial, clinically significant or severe low blood sugar occurred at 19.9 against 10.4 events per patient-year versus daily degludec, a rate ratio near 1.9 with a 95 percent interval of 1.5 to 2.3.
- Human trialBlood sugar control itself was non-inferior in that trial. The problem was never efficacy; it was the hypoglycemia rate.
Practical features a reader should recognize
FDA-approved- RegulatoryThe pen is U-700, seven times the concentration of a standard U-100 insulin pen. It delivers in 10-unit steps.
- RegulatoryTransfer from a daily basal insulin begins with a one-time 50 percent additional dose, not a straight seven-fold conversion.
- RegulatoryThe label half-life is approximately one week, independent of dose, so a dosing error persists for days.
The headline error is treating this and the other once-weekly insulin as the same product, or as versions of one another. They are separate molecules with separate approvals: different substitutions, different ways of lasting a week, different half-lives of about one week against about 17 days, and different pen strengths. Neither was filed as a biosimilar of the other. The second error is reading the US type 2 restriction as a formality. It is the direct result of a 7-to-4 advisory committee vote against type 1 use, on the strength of a roughly doubled rate of serious hypoglycemia. The third is the mirror image: because the European, Canadian and Australian labels do cover type 1, a reader who finds a non-US leaflet may conclude the US label is simply out of date. It is not. Those are different regulatory judgments about the same evidence. Last, the convenience framing undersells the pen: U-700 is an unusual concentration and the reason dose errors here matter more than with an ordinary insulin.
The published record
Papers and trials about Insulin Icodec (Awiqli)
Searched: icodec, insulin icodec, Awiqli, ONWARDS.
Left out: insulin (the bare term returns on the order of tens of thousands of records across a century of endocrinology; this is the most important rejection on this row); basal insulin (a class term covering glargine, degludec, detemir and NPH, none of which is this molecule); once-weekly insulin (a dosing descriptor that also matches insulin efsitora alfa, which has its own slug); insulin degludec (the comparator in the type 1 trial, with its own large literature); Novo Nordisk (a company name spanning an entire portfolio).
153 papers tagged human · 74 not reviews or lab · 39 clinical trial publications
40 registered trials · 14 with posted results
Furthest stage reached: Approved in the US
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count.
At a glance
Four things to know about Insulin Icodec (Awiqli)
Evidence
FDA-approved
Category
Weight loss and metabolic
Common vial
Varies
Half-life
About one week
How much, and do you cycle it?
The range, and whether you take breaks.70 units a week to start, once weekly. Continuous weekly dosing FDA label
Basal insulin replacement is continuous treatment for a chronic condition. No cycling scheme applies, and interrupting it in type 2 diabetes risks loss of glycemic control.
How long does it stay in the body?
The half-life, and where the figure comes from.About one weekFDA label
The label states the subcutaneous half-life is approximately one week and independent of dose. This is one of the few compounds on this site where a weekly schedule reflects a true week-long half-life. The consequence is symmetrical: steady levels, and no way to reverse an excessive dose quickly.
Source: Awiqli prescribing information, section 12.3
You can compare this against the whole library to see where it sits.
How is it given?
Dosing context and source notes.Supplied as a pen or prefilled syringe, so there is nothing to mix.
Label dose: 70 units per week.
70 units once weekly is the label's starting dose for someone not already on insulin. There is no maximum: the dose is titrated to the individual, and the pen delivers in 10-unit steps while the trials titrated in 20-unit steps. Switching from a daily basal insulin uses a one-time first dose of 1.5 times the total daily dose multiplied by seven, described in the label as a one-time 50 percent additional dose. A missed dose can be taken within 4 days. These figures are the label's, recorded here so a reader can recognize them, not guidance to act on.
How do you store it?
Before mixing, and after.Follow the storage on the product label.
Insulin Icodec (Awiqli) is supplied as a finished product, so its label sets the storage. Pens, prefilled syringes, implants, tablets and ready-made solutions are used as supplied. Kits that include a powder are mixed just before the dose and usually used straight away, not kept for weeks. Many injectable products go in the fridge and must not be frozen, while others are kept at room temperature, so check the pack or ask the pharmacist.
What are the side effects and cautions?
Known cautions and warnings for this compound.Who should avoid it
- Type 1 diabetes in the United States: not an approved use, and the FDA advisory committee voted against it on hypoglycemia grounds
- Episodes of low blood sugar, and known hypersensitivity to insulin icodec
- Treating it as interchangeable with the other once-weekly insulin: they are different molecules with different half-lives and different pen strengths
Stop and get help
- Signs of severe low blood sugar, such as confusion, seizure or loss of consciousness, since that is an emergency
- Signs of a systemic allergic reaction
Common effects
- Low blood sugar, the expected effect of any insulin given in excess of need
- Injection-site reactions and, with any insulin, the possibility of weight gain
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Insulin Icodec (Awiqli) approved?
And where the numbers on this page come from.Yes. Insulin Icodec (Awiqli) is FDA approved and available on prescription in the United States. It is also approved in the European Union, Canada, and Australia.
- Approval statusFDA-approved
- RouteUnder the skin (subcutaneous)
- Checked30 October 2026
- Approved outside the USEuropean Union, Canada, Australia.This does not change the United States position above.
- DoseFrom the drug label. The manufacturer tested this range and a regulator reviewed it.
- Vial sizeFrom what vendors typically list; not a recommendation.
- Sources
What has happened recently
FDA-approved for adults with type 2 diabetes. The approval came on the second review cycle after a complete response letter, and the US indication is narrower than the one granted elsewhere. The label covers type 2 diabetes and we found no mention of type 1 anywhere in it, with no limitation-of-use statement and no boxed warning. That silence is worth understanding rather than reading as reassurance: the FDA's Endocrinologic and Metabolic Drugs Advisory Committee met on May 24, 2024 and voted 7 to 4 against recommending the drug for adults with type 1 diabetes, citing higher rates of level 2 and level 3 hypoglycemia against once-daily degludec. The European Union authorized it in May 2024 for the treatment of diabetes mellitus in adults, and the Canadian and Australian authorizations also cover type 1. So a reader comparing a European or Australian product leaflet against the US label is looking at two different regulatory decisions about the same molecule, not at a translation difference.
You can compare this against the whole library, or read how to check a seller.
What else is like Insulin Icodec (Awiqli)?
Others in Weight loss and metabolic, side by side.If you're weighing Insulin Icodec (Awiqli), it's worth reading Insulin Efsitora Alfa (Onswik), Macupatide (LY3532226), and Nisotirostide (LY3457263) in the same class.
One injection a week, and a half-life that really does last one.
- Dose
- 70 units a week to start
- How often
- Once weekly
Approved, not yet available, and honest about type 1 on its own label.
- Dose
- 100 units a week to start
- How often
- Once weekly
The experiment that isolates what GIP does.
- Dose
- No established dose
- How often
- Not established
A gut-hormone analog that only works as an add-on.
- Dose
- No established dose
- How often
- Not established
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
- Semaglutide vs Tirzepatide vs Retatrutide
One receptor, two, or three. Mechanism, trial weight loss, side effects, and real cost.
Sources
- Awiqli (insulin icodec-abae) prescribing information, DailyMed(2026)The label itself, last updated March 26, 2026. Indication verbatim: an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. No boxed warning and no mention of type 1 diabetes was found in the retrieved text. Section 11 gives the molecular formula C280H435N71O87S6, molecular weight 6380.26 Da, the omission of threonine at B30, the substitution of Tyr(A14) with Glu and of Tyr(B16) and Phe(B25) with His. Dosing: weekly starting dose 70 units in insulin-naive patients; supplied as 700 units per mL (U-700); the FlexTouch pen delivers 10-unit increments while the trials titrated in 20-unit increments; transfer from daily basal insulin uses a one-time dose of 1.5 times the total daily basal dose multiplied by seven, described in section 12.3 as a one-time 50 percent additional dose; a missed dose may be given within 4 days. Section 12.3 states the subcutaneous half-life is approximately one week independent of dose.
- Healio report of the FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting(2024)Meeting coverage dated May 24, 2024. The committee voted 7 to 4 against the position that the benefits outweigh the risks for adults with type 1 diabetes, citing higher rates of level 2 and level 3 hypoglycemia against once-daily insulin degludec in the ONWARDS 6 trial, and saying more data were needed on the proposed hypoglycemia mitigation strategies. The vote tally is cited to this meeting report rather than to an FDA document, because the FDA's own posted meeting material carries the voting questions without the tally.
- Rosenstock and colleagues, New England Journal of Medicine, ONWARDS 1(2023)The pivotal type 2 trial against insulin glargine U-100 in 984 participants. The treatment difference in HbA1c favored icodec and met both non-inferiority and superiority. Note a discrepancy worth knowing: the published estimate and the figure printed in the FDA label are not identical, and they are reported here as two separate numbers rather than averaged. DOI resolved at Crossref.
- Russell-Jones and colleagues, The Lancet, ONWARDS 6(2023)The type 1 diabetes trial, 582 participants, against insulin degludec. HbA1c non-inferiority was confirmed, with a treatment difference close to zero. The hypoglycemia result is the reason this page exists in the form it does: combined clinically significant or severe episodes ran at 19.9 against 10.4 events per patient-year, a rate ratio of about 1.9 with a 95 percent interval of 1.5 to 2.3. This is the trial the FDA advisory committee cited. DOI resolved at Crossref.
Beyond these, 218 records are indexed. Browse the records