TheraRadar
Data updated: May 26, 2026

APIDRA SOLOSTAR (insulin glulisine recombinant)

Trial Activity: Mature
Metabolic Approved 2004-04-16

APIDRA SOLOSTAR is indicated for the treatment of Diabetes.

Source: FDA Label • Sanofi
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

Development Insights

Sanofi conducting 12 trials (43%)
20 indications explored (Broad Platform)
→ diabetes mellitus, type 2 (7 trials)
→ diabetes mellitus, type 1 (6 trials)
→ type 1 diabetes mellitus (3 trials)
3
Indications
--
Phase 3 Trials
22
Years on Market

Details

Status
Prescription
First Approved
2004-04-16
Routes
SUBCUTANEOUS
Dosage Forms
INJECTABLE

Companies

Sanofi
Active Ingredient: INSULIN GLULISINE RECOMBINANT

APIDRA SOLOSTAR Approval History

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
18 FDA actions from 2004 to 2022 · 2 indication expansions
Nov 2022 SUPPL
Label · Labeling
FDA Letter Label
Nov 2019 SUPPL
Label · Labeling
FDA Letter
Dec 2018 SUPPL
Label · Labeling
Label

What APIDRA SOLOSTAR Treats

1 indications

APIDRA SOLOSTAR is approved for 1 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Diabetes
Source: FDA Label

APIDRA SOLOSTAR Competitive Set

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

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

KIRSTY
BIOCON BIOLOGICS
2025 1 indic.
MERILOG
SANOFI-AVENTIS U.S.
2025 1 indic.
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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 APIDRA SOLOSTAR's indications

See all emerging drugs →

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

Frexalimab SAR441344
Sanofi
CD40LG · monoclonal antibody (anti-CD40L, Fc-engineered to avoid platelet activation) · 4 Phase 3 trials

Drugs Similar to APIDRA SOLOSTAR

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1 shared
SANOFI-AVENTIS US
Shared indications:
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ADMELOG SOLOSTAR
INSULIN LISPRO
1 shared
SANOFI-AVENTIS US
Shared indications:
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AFREZZA
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Clinical Trial Registry

27 trials
Trial Sponsor ID Phase Status Title
NCT04124302 Mixed Meal Bolus Ph 4 completed The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal.
NCT04019821 SuperBolus Ph 4 completed Super-Bolus: Effects on Postprandial Glycemia After High Glycemic Index Meal
NCT00913497 results posted 2009-089 Ph 4 completed The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children
NCT03359837 SWITCH LANTUL07194 U1111-1186-3400 Ph 4 completed Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy
NCT02910518 BEQ13941 2016-001498-34, U1111-1183-8636 Ph 1 completed A Study to Demonstrate Bioequivalence Between Insulin Glulisine U300 and Insulin Glulisine U100 After a Single Subcutaneous Dose Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus
NCT02503501 results posted IN-INSUL-MCI-AD Ph 2 terminated Intranasal Glulisine in Amnestic Mild Cognitive Impairment and Probable Mild Alzheimer's Disease
NCT02432716 results posted HealthPartnersRF Ph 1 completed Investigation of the Safety of Intranasal Glulisine in Down Syndrome
NCT01194245 results posted HALO-117-205 Ph 2 completed Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus
NCT01848990 results posted Halo-117-403 Ph 4 completed CONSISTENT 1: Metabolic and Safety Outcomes of Hylenex Recombinant (Hyaluronidase Human Injection) Preadministered at CSII Infusion Site in Participants With Type 1 Diabetes Mellitus (T1DM)
NCT01662921 APIDRL06229 Ph 2 completed Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes
NCT02276859 Protein Food Insulin Bolus Ph 4 completed Normal Versus Dual Wave Insulin Bolus for High-protein Food
NCT02276196 ELIXIRS DC2014ELIX001 Ph 4 completed Effect of LIXIsenatide on the Renal System
NCT01436045 results posted 11-111 Ph 2 completed Safety and Effectiveness Study of Intranasal Insulin Glulisine on Cognitive and Memory in Mild-Mod AD Patients.
NCT01131052 DMElderly results posted IRB00038789 Ph 4 completed Diabetes in the Elderly: Prospective Study
NCT01678235 Glulisine_Aspart Ph 4 completed Insulin Glulisine and Aspart in Postprandial Glycemic Control After High-GI Meal in Children With Type 1 Diabetes Mellitus
NCT01194258 results posted HALO-117-206 Ph 2 completed Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus
NCT00979875 results posted HALO-117-104 Ph 1 completed A Pharmacokinetic and Glucodynamic Study of Subcutaneously Administered Insulin Analogs With rHuPH20 Compared to Insulin Analogs Alone
NCT01204593 SUBSTITUTE LANTU_R_05033 U1111-1116-3450 Ph 4 completed baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus
NCT01122979 DINAMO LANTU_L_04737 Ph 4 completed Evaluation of the Safety and Efficacy of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) Use in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure.
NCT01212913 B to B LANTU_L_04867 U1111-1117-2786 Ph 4 completed Comparison of Insulin Glargine/Insulin Glulisine Regimen to Insulin Aspart/Insulin Aspart Protamine 30/70 in Type 2 Diabetes Mellitus Patients (T2DM)
NCT01079364 BASAAL PLUS APIDR_L_04717 2009-015742-34 Ph 4 terminated Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting
NCT01121835 GALAPAGOS LANTU_C_04589 2009-018172-33, U1111-1116-9859 Ph 4 completed Insulins Glargine and gluLisine strAtegy Versus Premixed Insulin strAteGy: a cOmparative Study
NCT00965549 LanScape LANTU_L_04211 2008-007026-19(EudraCT) Ph 4 completed Comparison of a Basal Plus One Insulin Regimen With a Biphasic Insulin Regimen in Type 2 Diabetes Patients
NCT01202474 APIDR_L_04884 U1111-1116-8645 Ph 4 completed Apidra Children & Adolescents Study
NCT01203111 CHANGING LANTU_R_05048 U1111-1116-3517 Ph 4 completed Intensive Insulin Glulisine Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs
NCT01081938 LANTU_L_04572 U1111-1116-9777 Ph 4 terminated Insulin Glargine for Diabetes Metabolism(DM)Type II Patients Under Enteral Nutrition
NCT00607087 PUMP results posted APIDR_C_02083 2007-003579-38 Ph 4 completed Effect of Insulin Glulisine Compared to Insulin Aspart and Insulin Lispro When Administered by Continuous Subcutaneous Insulin Infusion (CSII) on Specific Pump Parameters in Patient With Type 1 Diabetes Mellitus
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

APIDRA SOLOSTAR FDA Label Details

Indications & Usage

FDA Label (PDF)

APIDRA SOLOSTAR is indicated for the treatment of Diabetes.

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Data Sources

FDA Approval: BLA021629 → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment