protamine insulin
Animal productapproved
Approved
Sep 25, 1950
Neutral Protamine Hagedorn (NPH) insulin, also known as isophane insulin, is an intermediate-acting insulin given to help control blood sugar levels in people with diabetes. The words refer to neutral pH, protamine a protein, and Hans Christian Hagedorn, the insulin researcher who invented this formulation. It is designed to improve the delivery of insulin, and is one of the earliest examples of engineered drug delivery. — Wikipedia
Clinical trial activity
14 trials · 21 clinical orgs · 4 marketing orgs
Phase 1
0
Phase 2
4
Phase 3
3
Phase 4
9
Earliest trial started Feb 1, 2001 (NCT03220425)
Timeline
1950s
- Sep 25, 1950
Earliest FDA Approval
- Sep 25, 1950
Bristol-Myers Squibb — NDA Secondary Org
1970s
- Dec 5, 1979
Eli Lilly — NDA Secondary Org
1980s
- Mar 17, 1980
Novo Nordisk — NDA Secondary Org
2000s
- Jan 1, 2001
Novo Nordisk — Earliest Phase 3 Sponsor(trial)
2020s
- Jan 1, 2021
Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Mechanism of action
- Insulin receptorAGONIST
INSR agonist
Approval history
- approvedSep 25, 1950
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Discontinued
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaNPH insulin ↗
- ChEMBLCHEMBL2109046 ↗
- ChEMBLCHEMBL1201656 ↗
- ChEMBLCHEMBL1201653 ↗
- ChEMBLCHEMBL1201643 ↗
- ChEMBLCHEMBL1201635 ↗
Also known as
- ins hypurin bov prot zn
- ins prot zn bp
- insulin aspart [rdna origin]
- insulin insulatard nph nordisk
- insulin susp isophane beef/pork
- insulin susp isophane beef/pork
- insulin susp isophane purified pork
- insulin susp isophane purified pork
- insulin zinc susp prompt purified pork
- insulin zinc susp prompt purified pork
- insulin zinc susp purified pork
- insulin zinc susp purified pork
- lente
- lente iletin ii (pork)
- novomix
- nph iletin i (beef-pork)
- nph iletin ii (pork)
- nph purified pork isophane insulin
- regular iletin ii (pork)
- regular purified pork insulin
- semilente
- velosulin
- velosulin
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06999551 | Phase 4 | Jul 1, 2025 | Les Laboratoires des Médicaments Stériles |
| NCT06619301 | Phase 3 | Apr 1, 2024 | Loyola University |
| NCT05124457 | Phase 2 | Nov 30, 2021 | University of California, Los Angeles |
| NCT05709938 | Phase 4 | Nov 1, 2019 | King Edward Medical University |
| NCT04664764 | Phase 4 | Feb 21, 2019 | Ain Shams University |
| NCT03620890 | Phase 4 | Sep 3, 2018 | University of Texas at Houston |
| NCT03511521 | Phase 4 | Mar 27, 2018 | Northwestern University |
| NCT03389490 | Phase 4 | Jan 1, 2018 | Chinese University of Hong Kong, Sanofi |
| NCT03350984 | Phase 4 | Nov 2, 2017 | Universidad de Guanajuato |
| NCT04726631 | N/A | Jan 1, 2015 | Assiut University |
| NCT03507829 | Phase 3 | Nov 21, 2012 | Humboldt University, Medical University of Graz, Medical University of Vienna, Universidad Autonoma de Barcelona |
| NCT00821795 | Phase 4 | Feb 1, 2009 | Department of Veteran Affairs, Novo Nordisk, University of Kentucky |
| NCT00657943 | Phase 4 | Apr 1, 2008 | Novo Nordisk, Steno Diabetes Center Copenhagen, University Hospital Koge, University of Copenhagen |
| NCT03220425 | Phase 3 | Feb 1, 2001 | Novo Nordisk |
Showing 14 of 14 trials
Page 1 / 1
Organizations
Research & Development (21)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Novo Nordisk | For profit | 3 | 1 | 2 | 2001 |
| Ain Shams University | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Assiut University | Academic/Hospital | 1 | 1 | 1 | 2015 |
| Chinese University of Hong Kong | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Department of Veteran Affairs | Government | 1 | 1 | 1 | 2009 |
| Humboldt University | Academic/Hospital | 1 | 0 | 1 | 2012 |
| King Edward Medical University | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Les Laboratoires des Médicaments Stériles | For profit | 1 | 1 | 1 | 2025 |
| Loyola University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Medical University of Graz | Academic/Hospital | 1 | 0 | 1 | 2012 |
| Medical University of Vienna | Academic/Hospital | 1 | 1 | 1 | 2012 |
| Northwestern University | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Sanofi | For profit | 1 | 0 | 1 | 2018 |
| Steno Diabetes Center Copenhagen | Academic/Hospital | 1 | 1 | 1 | 2008 |
| Universidad Autonoma de Barcelona | Academic/Hospital | 1 | 0 | 1 | 2012 |
| Universidad de Guanajuato | Academic/Hospital | 1 | 1 | 1 | 2017 |
| University Hospital Koge | Academic/Hospital | 1 | 0 | 1 | 2008 |
| University of California, Los Angeles | Academic/Hospital | 1 | 1 | 1 | 2021 |
| University of Copenhagen | Academic/Hospital | 1 | 0 | 1 | 2008 |
| University of Kentucky | Academic/Hospital | 1 | 0 | 1 | 2009 |
21 organizations
Page 1 / 2
Marketing (5)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bristol-Myers Squibb | For profit | NDA2 | Sep 25, 1950 |
| Bristol-Myers Squibb | For profit | NDA2 | Sep 25, 1950 |
| Eli Lilly | For profit | NDA2 | Dec 5, 1979 |
| Nordisk | For profit | NDA | Jun 1, 1946 |
| Novo Nordisk | For profit | NDA2 | Mar 17, 1980 |