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Faster aspart (Fiasp)

Novo Nordisk

What it is

An ultra-rapid mealtime insulin — insulin aspart reformulated with niacinamide (and L-arginine) to speed early absorption, appearing in the blood about twice as fast as standard aspart and trimming post-meal spikes.

Editorial review: .

Source dates appear in the references where available; this record has no dated citation metadata.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

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Available nowRegulator-approvedrapidultra-rapidmealtime

Evidence behind this assessment

Key evidence notes. Study results, product eligibility and access answer different questions.

Who was studied?
Study populations and analysis groups vary. Product age limits alone do not describe who was studied.See the linked studies and their populations →
Benefit or performance
Consistency: Within-patient day-to-day variability in glucose-lowering is reported as ~18-19% in pharmacology studies; predictable, though injection-site reactions are reported slightly more often than with aspart.[1]
Important harms and treatment burden
Read the safety discussion and original sources. A missing summary does not establish safety.
Approval and country access
Country-specific approval and access are not summarized in this record.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
Follow-up and remaining uncertainty
Read the full discussion and original sources for follow-up duration and study limitations.
Editorial score: calculation and evidence

A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.

Default calculation: 72 × 20 + 60 × 25 + 58 × 15 + 64 × 20 + 56 × 10 + 58 × 10 = 6230; divide by total weight 100. Unrounded weighted result: 62.3.

Onset speed72

Among mealtime peers: insulin appears ~2.5 min after injection and glucose-lowering begins ~16-20 min — onset ~2x faster than standard aspart, but still not physiologic.[1]

Time to peak60

Mealtime convention (faster peak = better): time-to-peak effect ~91-133 min depending on dose; earlier and larger early action than aspart but maximum is still ~1.5-2 h out.[1]

Short tail58

Mealtime convention (shorter tail = better): duration ~5-7 h (dose-dependent) with earlier offset than aspart in pumps (~24 min sooner), but the tail is only modestly cleaner.[5]

Consistency64

Within-patient day-to-day variability in glucose-lowering is reported as ~18-19% in pharmacology studies; predictable, though injection-site reactions are reported slightly more often than with aspart.[1]

Exercise flexibility56

Faster off-rate helps marginally around activity, but a multi-hour tail still complicates exercise and unannounced exertion.[4]

Access & cost58

Access convention (cheaper/more available = better): widely approved and pump-cleared, but brand-only with no biosimilar; high out-of-pocket cost without insurance, though manufacturer caps sometimes reduce what patients pay.[10]

Insulins are scored relative to their role peers (see tags: rapid, ultra-rapid, basal, inhaled). A basal insulin's onset score compares it to other basals, not to mealtime insulins.

Editor’s take

A real but incremental step. The pharmacology genuinely left-shifts versus aspart — among the fastest in its class alongside Lyumjev — and it shines in pumps and closed-loop, where every saved minute compounds. But it doesn't erase the fundamental subcutaneous lag, which is exactly why the insulin-speed gap remains.

The full picture

Faster aspart is the rapid-acting analog insulin aspart reformulated with two excipients — niacinamide (vitamin B3), which speeds early absorption, and L-arginine, which stabilizes the formulation.6 It is a mealtime (bolus) insulin: you take it to cover the carbohydrate in a meal, alongside a separate long-acting basal insulin or as the bolus insulin in a pump.1

How fast, exactly? After a subcutaneous injection, insulin aspart appears in the bloodstream in about 2.5 minutes, with peak insulin concentration around 63 minutes.1 The glucose-lowering effect starts at roughly 16-20 minutes, reaches its peak at about 91-133 minutes (later and larger with bigger doses), and fades over 5-7 hours; the terminal half-life is about 1.1 hours.1 Compared with standard aspart, faster aspart roughly doubles the early insulin exposure and delivers up to 2.5-fold more glucose-lowering action in the first 30 minutes — the curve is shifted earlier at both ends.4 In a pump, it turns on about 11 minutes sooner and off about 24 minutes sooner than aspart.5 The speed comes from niacinamide: it increases the fraction of insulin present as fast-absorbing monomers by ~35%, boosts transport across blood-vessel walls by ~27%, and causes a brief local widening of small vessels.6

Does it help in real life? In the 26-week onset 1 trial in adults with type 1 diabetes, mealtime faster aspart matched aspart on overall HbA1c and was superior for the post-meal glucose rise at both 1 and 2 hours.7 In pumps (onset 5), it again held HbA1c non-inferior and improved 1-hour post-meal glucose, though investigators noted a numerical imbalance in severe hypoglycemia worth watching.8 In children and adolescents, onset was about twice as fast with greater early exposure, supporting use across ages.9

Consistency and exercise. Day-to-day variation in its glucose-lowering effect within a person is reported as modest (~18-19%) in pharmacology studies.1 The faster on/off profile may be only a marginal help around activity, but a multi-hour tail still means active insulin can drive lows during or after exercise — plan ahead.

Delivery, approvals, dosing. It comes in FlexTouch pens, vials, PenFill cartridges, and a PumpCart cartridge.1 The EU authorised it on 9 January 2017, later extended to children aged 1 year and older.2 The FDA approved it in 2017 and expanded the label for insulin-pump use in adults in October 2019.3 A standout practical feature: it can be dosed at the start of a meal or up to 20 minutes after starting to eat — useful for unpredictable appetites in young children.1

Access and cost. It is approved across the US, UK, EU, Canada, Australia, and Japan, but remains brand-only — there is no biosimilar or generic (patent protection was reported to run to about 2026), and US out-of-pocket costs are high without insurance, sometimes partly offset by manufacturer caps and insurance.10

What's coming. Faster aspart's real frontier is automation: because closed-loop systems must react to glucose through the insulin-action lag, even a few saved minutes may matter, and faster aspart is being studied for use in hybrid closed-loop and fully-closed-loop research. But it does not remove the underlying subcutaneous delay — which is why the field is pursuing genuinely ultra-fast and intradermal formulations to close the insulin-speed gap.

What's next for this

  • →Ongoing research use in hybrid and fully-closed-loop automated insulin delivery, where faster onset may benefit closed-loop control

Sources

  1. [1]
    FIASP (insulin aspart injection) US Prescribing Information · Regulatory decision — PK/PD numbers — onset ~2.5 min, Tmax ~63 min, peak effect ~91-133 min, duration ~5-7 h, half-life ~1.1 h, variability ~18-19%; adult + pediatric indication; mealtime/within-20-min dosing; CSII use.

    Novo Nordisk. FIASP (insulin aspart injection) US Prescribing Information — Dosage and Administration.

    Novo Nordisk. FIASP (insulin aspart injection) US Prescribing Information — Clinical Pharmacology (12.2, 12.3).

  2. [2]
    Fiasp — European Public Assessment Report (EPAR) · Regulatory decision — EU marketing authorisation 9 Jan 2017; indication extended to children aged 1 year and above.

    European Medicines Agency. Fiasp — European Public Assessment Report (EPAR).

  3. [3]
    FDA approves Fiasp for use in insulin infusion pumps for adults with type 1 or type 2 diabetes · Regulatory decision — US pump (CSII) label expansion, 22 Oct 2019, based on onset 5.

    Novo Nordisk. FDA approves Fiasp for use in insulin infusion pumps for adults with type 1 or type 2 diabetes (22 Oct 2019).

  4. [4]
    Haahr H, Heise T. Fast-Acting Insulin Aspart: A Review of its Pharmacokinetic and Pharmacodynamic Properties and the Clinical Consequences. Clin Pharmacokinet (2020) · Peer-reviewed study — Up to 2.5-fold greater glucose-lowering effect within first 30 min; left-shifted profile; PMC7007438.
  5. [5]
    Biester T, Kordonouri O, Danne T. Pharmacological Properties of Faster-Acting Insulin Aspart. Curr Diab Rep (2017) · Peer-reviewed study — In pump use, faster on (-11 min), faster off (-24 min), >100% greater action in first 30 min vs aspart.
  6. [6]
    Kildegaard J, et al. Elucidating the Mechanism of Absorption of Fast-Acting Insulin Aspart: The Role of Niacinamide. Pharm Res (2019) · Peer-reviewed study — Niacinamide raises monomer fraction ~35%, endothelial permeability ~27%, plus transient local vasodilation; PMC6373292.

    Kildegaard J, Buckley ST, Nielsen RH, et al. Elucidating the Mechanism of Absorption of Fast-Acting Insulin Aspart: The Role of Niacinamide. Pharm Res (2019).

  7. [7]
    Russell-Jones D, et al. Fast-Acting Insulin Aspart Improves Glycemic Control in Basal-Bolus Treatment for Type 1 Diabetes (onset 1). Diabetes Care (2017) · Peer-reviewed study — 26-week phase 3; HbA1c non-inferior, mealtime faster aspart superior on 1-h and 2-h postprandial glucose.

    Russell-Jones D, Bode BW, De Block C, et al. Fast-Acting Insulin Aspart Improves Glycemic Control in Basal-Bolus Treatment for Type 1 Diabetes (onset 1). Diabetes Care (2017).

  8. [8]
    Klonoff DC, et al. A randomized, multicentre trial evaluating fast-acting insulin aspart in CSII in adults with type 1 diabetes (onset 5). Diabetes Obes Metab (2019) · Peer-reviewed study — 16-week pump trial; HbA1c non-inferior, superior 1-h postprandial glucose; numerical imbalance in severe hypos noted; PMC6590130.

    Klonoff DC, Evans ML, Lane W, et al. A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5). Diabetes Obes Metab (2019).

  9. [9]
    Fath M, et al. Faster-acting insulin aspart provides faster onset and greater early exposure vs insulin aspart in children and adolescents with type 1 diabetes. Pediatr Diabetes (2017) · Peer-reviewed study — Onset ~2x faster (5-7 min earlier) across ages; early exposure greater by 78-147%.

    Fath M, Danne T, Biester T, et al. Faster-acting insulin aspart provides faster onset and greater early exposure vs insulin aspart in children and adolescents with type 1 diabetes mellitus. Pediatr Diabetes (2017).

  10. [10]
    How much does Fiasp cost without insurance? (SingleCare) · Science journalism — High out-of-pocket cost for vials and pen cartons without insurance; no generic/biosimilar; patent to ~2026.

    SingleCare. How much does Fiasp cost without insurance?