TheraRadar
Data updated: May 26, 2026

HUMALOG TEMPO PEN (insulin lispro recombinant)

Metabolic Approved 1996-06-14

HUMALOG TEMPO PEN is indicated for the treatment of Diabetes.

Source: FDA Label • Eli Lilly
6
Indications
--
Phase 3 Trials
29
Years on Market

Details

Status
Prescription
First Approved
1996-06-14
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: INSULIN LISPRO RECOMBINANT

HUMALOG TEMPO PEN Approval History

1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
85 FDA actions from 1996 to 2025 · 4 indication expansions
May 2025 SUPPL
Label · Labeling
Jul 2023 SUPPL
Label · Labeling
Nov 2019 SUPPL
Label · Labeling

What HUMALOG TEMPO PEN Treats

1 indications

HUMALOG TEMPO PEN is approved for 1 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Diabetes
Source: FDA Label

HUMALOG TEMPO PEN Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Unlock 8 more competitors across all three rings.
Upgrade to Pro

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in HUMALOG TEMPO PEN's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications HUMALOG TEMPO PEN treats. First-in-class if their pivotal trials read out positive.

Drugs Similar to HUMALOG TEMPO PEN

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ADMELOG
INSULIN LISPRO
1 shared
SANOFI-AVENTIS US
Shared indications:
ADMELOG SOLOSTAR
INSULIN LISPRO
1 shared
SANOFI-AVENTIS US
Shared indications:
AFREZZA
INSULIN RECOMBINANT HUMAN
1 shared
MANNKIND
Shared indications:
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

HUMALOG TEMPO PEN FDA Label Details

Indications & Usage

FDA Label (PDF)

HUMALOG TEMPO PEN is indicated for the treatment of Diabetes.

Track HUMALOG TEMPO PEN with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.