Insulin human
As of the edition of 20 October 2026, Insulin human is a protein: marketed, first approved in 1982 (US); acts on INSR; US protection ended in 1994.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Protein
- Brand name
- Humulin R
- First approved
- 28 October 1982 (US)
- Approvals on record
- 102 in 6 regions
- Holder of the most recent approval
- NOVO NORDISK FARMACĂUTICA DO BRASIL LTDA; 17 holders in all
- Withdrawn from market
- 11 January 2018 (in some regions)
- Registered trials
- 434, 67 stopped early
- Disease areas
- Nutrition and metabolism; Hormones; Immune system; Nervous system; Heart and blood vessels; Mental health
US protection
US protection ended in 1994.
US protection ended in 1994, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Eli Lilly. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Insulin human.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| INSR | Insulin receptor | P06213 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 116 | 76 | 9 | 13 |
| Phase 1 | 58 | 39 | 6 | 6 |
| Phase 2 | 91 | 64 | 7 | 15 |
| Phase 3 | 87 | 55 | 5 | 24 |
| Phase 4 | 82 | 54 | 4 | 9 |
| All trials | 434 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eli Lilly | Applicant and Lead sponsor of trials | 1982 to now |
| Novo Nordisk | Later holder and Lead sponsor of trials | 1983 to now |
| Sanofi | Applicant and Lead sponsor of trials | 1997 to now |
| Pfizer | Later holder and Lead sponsor of trials | 1999 to now |
| Mannkind | Later holder and Lead sponsor of trials | 1999 to now |
| Baxter Healthcare | Applicant, Acquired holder and Lead sponsor of trials | 2020 to now |