Here you can find a summary of most known insulin formulations under development. We also mention insulins which have recently appeared on the market.
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
(insulin degludec / insulin aspart):
pre-mixed basal-bolus formulation.
|same as above|
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.
|Abasaglar / Basaglar
(insulin glargine biosimilar):
cheaper analogue of Sanofi’s Lantus
|Approved in Sep 2014.
Launched in Aug 2015 (UK).
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.
|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.
an ultra-rapid-acting inhaled insulin.
Previously marketed by Sanofi.
|Phase III clinical trials||launched in Jan 2015|
|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
|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|
Based in India. Develops cheaper versions of insulins which patents expired.
||Phase III clinical trials|
||Phase III clinical trials|
not yet in trials
Source: Biocon research pipeline
|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|
|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
- 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.