Insulin

In 1869, German medical student Paul Langerhans observed the presence of 'islands' of a unique type of cell in the pancreas, later known as pancreatic islets. Although he was unaware of their function at the time, this discovery laid the foundation for understanding the role of these cells in metabolism.

In 1909, the term 'insulin' was coined, derived from the Latin word for 'island', to describe the hypothetical substance believed to be produced by the pancreatic 'islet' cells discovered by Langerhans. This marked a significant milestone in the study of diabetes and metabolic disorders.

In 1910, British scientist Edward Albert Sharpey-Shafer hypothesized the existence of insulin, a chemical made by the pancreas that diabetics lack, leading to high levels of sugar in their blood and urine.

In 1916, Romanian physiologist Nicolas Paulescu demonstrated that an extract of pancreatic cells could reduce blood sugar levels in diabetic dogs.

General surgeon Frederick Banting realized the potential of extracting insulin from pancreatic islet cells as a treatment for diabetes after reading a paper on the relationship of the islets of Langerhans to diabetes.

On July 27, 1921, Canadian doctors Frederick Banting and Charles Best successfully isolated the hormone insulin, a significant breakthrough in diabetes treatment.

In the Fall of 1923, the University of Toronto allowed Eli Lilly's general distribution of insulin after an experimental period with limited distribution. This marked a significant milestone in diabetes therapy, as the value of insulin was proven during this period, leading to a transformative impact on diabetes treatment.

In October 1923, Eli Lilly became the first manufacturer to mass produce insulin, marking a significant milestone in the history of diabetes treatment and making insulin more widely accessible.

In 1924, evidence emerged that insulin might be a single protein, contrary to the previous belief that it was a cocktail of proteins. Scientists from Johns Hopkins University confirmed this hypothesis.

The Novo Syringe was introduced in 1925, providing a more accurate means for self-administering insulin.

In 1929, Banting published a paper on the history of insulin, documenting the journey of its discovery and the significant impact it had on diabetes treatment.

The shift towards viewing insulin as a single chemical entity rather than a heterogeneous extract in 1932 was a pivotal moment. This change allowed scientists to apply chemical rules for better purification of the insulin molecule.

In 1935, scientists from Johns Hopkins University definitively proved that insulin is indeed a single protein, marking a significant advancement in the understanding of this vital hormone.

A bill was introduced in Congress to require FDA certification of insulin and concomitant regulations. The 1941 Insulin Amendment became law 48 hours before the Toronto patent expired.

The patent for insulin and the method of its production, held by the University of Toronto's Insulin Committee, was due to expire on December 24, 1941. This expiration would mark the end of the Committee's control over insulin manufacturing and distribution.

In 1946, Hans Christian Hagedorn discovered NPH (Neutral Protamine Hagedorn) insulin, which extended the effects of insulin and reduced the number of injections needed for people with diabetes.

Frederick Sanger fully sequenced bovine insulin and determined its exact amino acid composition. This achievement led to a better understanding of the structure and function of insulin.

In 1971, an article in Guy's Hospital Gazette discussed the question of who actually discovered insulin, shedding light on the collaborative efforts that led to its identification.

In April 1977, FDA staff utilized gel electrophoresis to examine the purity of insulin, as reported in FDA Consumer.

In 1978, the first genetically engineered, synthetic 'human' insulin was produced using E. coli bacteria, paving the way for more effective and less allergenic insulin treatments for diabetes patients.

In 1980, the first commercially available human insulin was introduced. It was created using recombinant DNA technology, making it identical to the insulin produced by the human body. This breakthrough allowed for highly purified insulin production in unlimited quantities, significantly benefiting people with diabetes.

In 1981, advancements in chromatographic processing enabled firms to produce purer insulin, reducing the risk of anti-insulin antibodies and insulin resistance in patients.

On October 28, 1982, the FDA approved Humulin, the first biosynthetic human insulin product developed using recombinant DNA technology, marking a significant milestone in medical history.

In 1985, NovoPen® was introduced, revolutionizing insulin delivery for people with diabetes by allowing them to benefit from having their insulin released as needed throughout the day.

The Diabetes Control and Complications Trial in 1993 demonstrated the importance of glycemic control in reducing long-term complications of diabetes. This study highlighted the significance of managing blood sugar levels in patients with diabetes.

In 1995, the FDA's insulin certification program came to an end, leading to significant changes in the insulin marketplace.

Humalog, a fast-acting insulin analog, was approved by the FDA in 1996. It marked a significant development in diabetes therapeutics, providing patients with a more efficient insulin option.

In 1997, after 56 years of operation, FDA's insulin certification program concluded with the passing of the Food and Drug Administration Modernization Act (FDAMA), marking the end of an era that ensured consistent quality and potency standards for insulin products.

In 1999, the FDA approved the first continuous glucose monitoring (CGM) device for reading blood glucose levels. This approval brought hope to individuals with diabetes seeking better control over their health.

Novo Nordisk developed insulin aspart based on a similar principle to Lispro insulin. It aims to provide faster availability to cells, reducing the risk of hypoglycemia.

In 2001, the InDuo combination insulin delivery device and blood sugar monitor was introduced. This device aimed to provide a convenient solution for individuals managing diabetes by combining insulin delivery and blood sugar monitoring in one device.

In 2005, Lilly began the Lilly Camp Care Package program, which is one of the largest support initiatives for diabetes summer camps in the U.S.

In 2006, the first inhaled insulin, Exubera, was developed by Sanofi-Aventis and Pfizer. Despite initial excitement, the bulky inhaler device failed to gain acceptance from patients and providers, leading to its withdrawal from the market after two years.

In 2008, Novo Nordisk R&D introduced liraglutide GLP-1, a type of medicine that helps reduce blood sugar levels by enhancing insulin secretion and reducing appetite and food intake.

In 2009, Congress passed the Biologics Price Competition and Innovation Act, creating a 10-year timeline for transitioning insulin regulation to a new pathway allowing for biosimilar biologics.

In 2011, Lilly partnered with The Walt Disney Company to create educational resources for families with children with type 1 diabetes, addressing the global health crisis of non-communicable diseases like diabetes through a major corporate responsibility initiative.

In 2012, Novo Nordisk developed insulin degludec by modifying amino acids to create a more stable and long-lasting analog for once-daily basal insulin use.

In 2016, insulin glargine, the first insulin follow-on biologic, became available to people with type 1 and type 2 diabetes, offering a new treatment option for managing the condition.

On July 29, 2021, the FDA approved Semglee as the first interchangeable biosimilar insulin product, designed to enhance glycemic control in patients with Type 1 and Type 2 diabetes mellitus.

Mylan Pharmaceutical's Semglee, a lower-cost option to Lantus, was approved by the FDA. This approval aligns with the FDA's goal of promoting competition in the biological products market and improving access to affordable and high-quality medications for patients.

The American Chemical Society honored the development and commercialization of insulin by designating it as a National Historic Chemical Landmark. The ceremony took place at the Eugene and Marilyn Glick Indiana History Center.