Related Experiment Video
Updated: Jan 6, 2026
07:13
An Alternative and Validated Injection Method for Accessing the Subretinal Space via a Transcleral Posterior Approach
Published on: December 7, 2016
13.8K
One Subcutaneous 2-ml Injection of Mirikizumab is Bioequivalent to Two 1-ml Subcutaneous Injections in Healthy
Yuki Otani1, Christopher D Payne2, Edward V Loftus3
1Eli Lilly and Company, Indianapolis, Indiana, USA. otani_yuki@lilly.com.
Advances in Therapy
|November 28, 2025
Summary
Mirikizumab administered as a single 2-ml subcutaneous injection is bioequivalent to two 1-ml injections for ulcerative colitis maintenance. This simplified dosing may improve patient treatment adherence.
Area of Science:
- Pharmacology
- Gastroenterology
- Immunology
Background:
- Mirikizumab is an anti-interleukin-23 p19 monoclonal antibody used for ulcerative colitis and Crohn's disease.
- Current maintenance therapy for ulcerative colitis involves two 1-ml subcutaneous injections.
- Reducing injection volume and number may decrease injection site reactions and improve compliance.
Purpose of the Study:
- To assess the pharmacokinetic (PK) and safety comparability of a single 2-ml subcutaneous injection of mirikizumab versus two 1-ml subcutaneous injections.
- To evaluate potential improvements in treatment adherence with a simplified dosing regimen.
Main Methods:
- A Phase 1 study in healthy US adults randomized participants to receive either two 1-ml (100 mg each) or one 2-ml (200 mg) subcutaneous injection of mirikizumab.
- Participants were subrandomized by injection site (arm, abdomen, or thigh).
- Primary endpoint was PK, secondary endpoint was safety, with assessments up to 10 weeks post-dose.
Main Results:
- Pharmacokinetic parameters for the single 2-ml injection fell within the bioequivalence range compared to two 1-ml injections.
- Treatment-emergent adverse events were predominantly mild in both groups.
- No serious adverse events were reported, with similar safety profiles observed across injection site locations.
Conclusions:
- A single 2-ml subcutaneous injection of mirikizumab 200 mg is bioequivalent to two 1-ml injections.
- The safety profile was comparable between the two dosing regimens, with mostly mild adverse events.
- Reducing the number of subcutaneous injections could potentially enhance treatment adherence in clinical practice.
More Related Videos
06:32Protective Efficacy and Pulmonary Immune Response Following Subcutaneous and Intranasal BCG Administration in Mice
Published on: September 19, 2016
11.0K
05:44Author Spotlight: Creating a Versatile Experimental Autoimmune Encephalomyelitis Model Relevant for Both Male and Female Mice
Published on: October 13, 2023
2.2K
Related Concept Videos
01:16Bioequivalence: Overview
1.6K
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
1.6K
01:15Bioavailability Study Design: Healthy Subjects Versus Patients
126
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
126
01:13Bioequivalence studies: Biowaivers
197
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
197
01:09Bioequivalence of Drugs: Drugs with Multiple Indications
134
The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
134
01:17Equivalence: In Vitro and In Vivo Bioequivalence
188
Body:Bioequivalence studies are crucial in evaluating whether new drugs can match an approved one regarding pharmacological effects and clinical performance. These studies test if drugs, despite different dosage forms, share identical plasma concentration-time profiles. Three types of equivalence are central to these studies: chemical, pharmaceutical, and therapeutic. Chemical equivalence indicates that two or more drug products contain identical active ingredients in equal amounts.
188
01:11Bioavailability Study Design: Single Versus Multiple Dose Studies
170
Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
170