The Future of Insulin: A List of New Insulin Formulations Under Development

Here you can find a summary of most known insulin formulations under development. We also mention insulins which have recently appeared on the market.

Novo Nordisk

Europe USA
FIAsp (NN-1218):
an ultra-rapid-acting formulation of NovoLog / NovoRapid (insulin aspart).
Phase III clinical trials
Can be ready in 2016
Tresiba (insulin degludec):
ultra-long acting basal insulin,
lasts 42+ hours,
with flexible time of dosing.
Day-to-day variability is 20%.
launched in 2013 approved in Sep 2015.
Expected launch: Q1 2016
Ryzodeg 70/30
(insulin degludec / insulin aspart):
pre-mixed basal-bolus formulation.
same as above

On EASD 2015, Novo presented materials from clinical trials for these insulin formulations. Novo Nordisk also explores using Victoza for type 1 diabetes (LATIN T1D trial).

From the current R&D pipeline of Novo Nordisk: two more insulin formulations are at a very early phase (Phase I) of clinical trials:

  • LAI338 (NN1438) – long-acting basal for daily administration
  • LAI287 (NN1436) – long-acting basal intended for once-weekly dosing

Novo Nordisk are interested in bringing more value to their products with new hardware/software technology:

Device Research & Innovation (DRI-US) vision to explore and develop new technology, product ideas, and game-changers that may hold the potential to add value to patients and Novo Nordisk in the future within therapeutic areas covered by Novo Nordisk corporate strategy.


Europe USA
Abasaglar / Basaglar
(insulin glargine biosimilar):
cheaper analogue of Sanofi’s Lantus
Approved in Sep 2014.
Launched in Aug 2015 (UK).
Launch postponed
to December 15, 2016
after a patent dispute with Sanofi
ultra-rapid insulin Phase I clinical trials

Recently, Lilly has cancelled plans to release their new basal insulin Peglispro because of liver safety issues in clinical trials.

Currently the company runs Phase III clinical trials for a non-insulin drug Empagliflozin (BI10773) for type 1 diabetes. Previously, Lilly collaborated on medications that extend life of beta cells.



Europe USA
Toujeo (insulin glargine U300, longer-acting version of insulin glargine) – with a goal of converting Lantus users to Toujeo, since the patents for Lantus have expired. Launched in Aug 2015 (UK) Launched in Apr 2015
SAR342434: new insulin lispro biosimilar to Lilly’s Humalog Phase III clinical trials

Sanofi is also developing LixiLan, a mix of basal insulin with GLP-1, targeted at type 2.

Sanofi and Evotec collaborate on developing beta cell replacement therapies, with a potential deal of €300M.


Europe USA
an ultra-rapid-acting inhaled insulin.
Previously marketed by Sanofi.
Phase III clinical trials launched in Jan 2015


Type Insulin Status
ultra-rapid acting BioChaperone Lispro – an accelerated version of lispro (Humalog) – in collaboration with Lilly – standard version U100 and concentrated version U200 Clinical trials
rapid acting Hinsbet U100 and U500 – cost-effective rapid insulin and its concentrated version Clinical trials
mixed BioChaperone Combo – mixed basal/bolus, a combination of Lantus and Humalog, mainly for type 2 Clinical trials

Source: Adocia website



Insulin Status
BIOD-123 – ultra-rapid acting insulin Phase II clinical trials
BIOD-238 and BIOD-250 – ultra-rapid acting insulin Phase I clinical trials
BIOD-531 – concentrated bolus/basal – ultra-rapid acting insulin with basal duration of action – primarily for type 2 Phase I clinical trials

Source: Slides for investors | Pipeline overview


Based in India. Develops cheaper versions of insulins which patents expired.


Insulin Status
  • Proprietary: new oral insulin IN-105
Phase III clinical trials
  • Generic glargine, cheaper version of Lantus (with Mylan)
  • Recombinant human insulin (rh-insulin)
Phase III clinical trials
  • Generic lispro, cheaper version of Humalog
  • Generic aspart, cheaper version of Novolog
early development,
not yet in trials

Source: Biocon research pipeline


Insulin Status
MK-2640 (“Smart Insulin”):
Glucose-responsive insulin which starts and stops working depending on glucose levels.
Expected launch: 2021 or later.
Previously known as “L-490“.
Phase I clinical trials
insulin glargine biosimilar (generic Lantus) Phase III clinical trials

Other companies

Company Insulin type Status
Generex insulin oral, insulin buccal (Oral-lyn, Oralgen) launched in United Arab Emirates and India, awaiting approval or Phase III trials in several other markets
Halozyme ultra-rapid acting: Insulin-PH20 & Analog-PH20 Phase II clinical trials
Oramed insulin oral Phase II clinical trials for T1D in Israel. An orally ingestible insulin capsule.

Open source insulin

As a part of do-it-yourself movement, there is an initiative to create an open-source protocol for insulin.

the Open Insulin project team is made up of roughly 50 self-described “hackers and tinkerers” who proudly point out they are all “bio-curious” — with a mix of genetic engineering, software, biochemistry and biotech experience. [..]
“People across the world are going without insulin because it’s so expensive, and we need to do something about that,” Anthony says. “Maybe someday, what we’re doing here could lead to a do-it-yourself insulin factory.”
Biohackers Creating Open-Source Insulin


Market trends:

  • new ultra-rapid acting insulins to replace Humalog and Novolog (patents expired), important for pump users and real-time artificial pancreas;
  • new attempts to create oral insulin, as ingestible capsules;
  • cheaper versions of Lantus and other insulins with expired patents;
  • new basal insulins with longer action, more important for type 2 diabetes;
  • mixed formulations for type 2 market: mixed basal/bolus and other mixed medications;
  • exploration of non-insulin drugs for glucose control in type 1 diabetes.
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The Future of Insulin: A List of New Insulin Formulations Under Development

3 thoughts on “The Future of Insulin: A List of New Insulin Formulations Under Development

    1. olga says:

      Sometimes they compare action of new insulins with Humalog.

      Example 1: BioChaperone Lispro is 35% faster than Humalog

      ultra-rapid acting insulin BioChaperone Lispro vs. Humalog

      Example 2: Afrezza absorbs faster than Humalog, but 8 units of Afrezza have less potency than 8 units of Humalog

      comparison of time-action of Afrezza vs. Humalog

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