Insulin Recombinant Human

For diabetes mellitus. Sold as Humulin R, Novolin R, Afrezza. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 3 applications for Insulin Recombinant Human (sold as Humulin R, Novolin R, Afrezza), first approved Oct 28, 1982, with 6 new uses approved and 0 published complete response letters.

First approved: Oct 28, 1982
Applications: 3
New uses approved: 6
Complete response letters: 0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

HUMULIN R 500 UNIT/ML KWIKPEN: $91.61 per MLBrand · 0% in a year
AFREZZA ((REGULAR INSULIN) 8 UNIT CARTRIDGE: $10.35 per unitBrand · +3% in a year
AFREZZA (REGULAR INSULIN) 12 UNIT CARTRIDGE: $15.59 per unitBrand · +3% in a year
AFREZZA (REGULAR INSULIN) 4 UNIT CARTRIDGE: $5.21 per unitBrand · +3% in a year
AFREZZA (REGULAR INSULIN) 60-4 UNIT/60-8 UNIT/60-12 UNIT: $10.32 per unitBrand · +2% in a year
AFREZZA (REGULAR INSULIN) 90-4 UNIT / 90-8 UNIT: $7.80 per unitBrand · +2% in a year
AFREZZA (REGULAR INSULIN) 90-8 UNIT / 90-12 UNIT: $13.04 per unitBrand · +3% in a year

Clinical Trials

3 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Physical Activity and Insulin Sensitivity DynamicsInsulin Sensitivity · University of Copenhagen	Not applicable	Recruiting	Jan 15, 2025
Human Models of Selective Insulin Resistance: Pancreatic ClampInsulin Resistance, Hyperinsulinemia · Columbia University	Phase 1	Not yet recruiting	Aug 16, 2024
Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes StudyCardiovascular Events, Type2 Diabetes · Brigham and Women's Hospital	—	Active, not recruiting	Feb 2, 2022

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Oct 28, 1982	Humulin RBLA 18780 · New molecular entity	Lilly	101	Marketed
Jun 25, 1991	Novolin RBLA 19938 · New formulation or manufacturer	Novo Nordisk Inc	50	Marketed
Jun 27, 2014	AfrezzaBLA 22472 · New formulation or manufacturer	Mannkind	14	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA