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Investigational Drug Information for Edivoxetine
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What is the development status for investigational drug Edivoxetine?
Edivoxetine is an investigational drug.
There have been 11 clinical trials for Edivoxetine.
The most recent clinical trial was a Phase 3 trial, which was initiated on November 1st 2010.
The most common disease conditions in clinical trials are Depressive Disorder, Major, Depressive Disorder, and Depression. The leading clinical trial sponsors are Eli Lilly and Company and [disabled in preview].
Summary for Edivoxetine
| US Patents | 0 |
| International Patents | 0 |
| US Patent Applications | 169 |
| WIPO Patent Applications | 36 |
| Japanese Patent Applications | 14 |
| Clinical Trial Progress | Phase 3 (2010-11-01) |
| Vendors | 19 |
Recent Clinical Trials for Edivoxetine
| Title | Sponsor | Phase |
|---|---|---|
| A Study of LY2216684 in Participants With Major Depression Disorder | Eli Lilly and Company | Phase 3 |
| A Study of LY2216684 in Healthy Participants | Eli Lilly and Company | Phase 1 |
| A Study in Prevention of Re-emergence of Depression Symptoms | Eli Lilly and Company | Phase 3 |
Clinical Trial Summary for Edivoxetine
Top disease conditions for Edivoxetine
Top clinical trial sponsors for Edivoxetine
US Patents for Edivoxetine
| Drugname | Patent Number | Patent Title | Patent Assignee | Estimated Expiration |
|---|---|---|---|---|
| >Drugname | >Patent Number | >Patent Title | >Patent Assignee | >Estimated Expiration |
Edivoxetine: Development Trajectory and Market Potential
Edivoxetine, a selective norepinephrine reuptake inhibitor (SNRI) developed by Eli Lilly and Company, is undergoing renewed clinical development, primarily targeting Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. The drug, previously discontinued due to efficacy concerns in adults, is now being investigated in pediatric populations, representing a potential second life for the compound. This analysis details current development status, patent landscape, and projected market entry.
What is the current development status of Edivoxetine?
Eli Lilly's current investigational pipeline lists Edivoxetine (LY2140023) as being in Phase 2b clinical trials for the treatment of ADHD in pediatric patients [1]. This signifies a shift from previous adult-focused development, acknowledging potentially different pharmacological responses and therapeutic benefits in younger demographics.
The Phase 2b trials are designed to evaluate the efficacy and safety of Edivoxetine across various dosages in children and adolescents diagnosed with ADHD. Data from these trials will be critical in determining the drug's viability for progression to Phase 3 studies. The historical context of Edivoxetine's development is important; while it demonstrated some efficacy in adult ADHD trials, it did not meet primary endpoints for statistically significant improvement over placebo in certain studies [2]. This led to its discontinuation for adult indications. However, the distinct neurobiological profiles of pediatric ADHD may present a different therapeutic window for the SNRI mechanism.
Key trials currently active or recently completed include:
- Study ID: NCT05753916 (A Phase 2b Study of LY2140023 in Pediatric Participants With Attention-Deficit/Hyperactivity Disorder) [1]
- Status: Recruiting
- Indication: ADHD in pediatric participants
- Design: Randomized, double-blind, placebo-controlled, dose-ranging study.
- Primary Outcome Measures: Change from baseline in the ADHD Rating Scale-IV (ADHD-RS-IV) total score.
- Secondary Outcome Measures: Includes changes in CGI-I (Clinical Global Impression-Improvement) scores, safety and tolerability assessments.
The focus on a pediatric population is a strategic pivot. Pediatric ADHD is a substantial market with ongoing demand for novel and effective treatments. Factors influencing treatment choices in this demographic include efficacy, side effect profiles, and ease of administration.
What is the patent landscape for Edivoxetine?
Eli Lilly holds a portfolio of patents protecting Edivoxetine and its therapeutic uses. The expiration of these foundational patents will significantly influence the post-exclusivity market environment.
Key patent information impacting Edivoxetine's exclusivity includes:
- US Patent 8,158,644 B2: Issued January 13, 2012. Covers "Norepinephrine Reuptake Inhibitors." This patent is a foundational composition of matter patent for compounds including Edivoxetine. The expiration of such broad patents is typically in the range of 20 years from the filing date, potentially leading to generic competition around 2025-2030, subject to any extensions.
- US Patent 8,735,393 B2: Issued May 27, 2014. Titled "Compositions and Methods for Treating Attention Deficit Hyperactivity Disorder." This patent focuses specifically on the use of Edivoxetine for ADHD treatment. This therapeutic use patent is crucial for extending market exclusivity beyond the base composition patent, especially if new indications are approved. The term of this patent is also subject to its filing date and potential patent term extensions (PTEs).
- Other International Patents: Eli Lilly has pursued patent protection for Edivoxetine in major pharmaceutical markets globally, including Europe, Japan, and other key regions. The expiration timelines in these jurisdictions will mirror the general trends seen in the U.S., though local patent laws and extension provisions can create variations.
Patent Expiration Projections:
Based on typical patent terms (20 years from the earliest priority date) and considering potential patent term extensions granted for regulatory delays, the primary patent protection for Edivoxetine's composition and its use in ADHD could expire in the mid-to-late 2020s.
- Composition of Matter Patents: Likely expired or nearing expiration in the immediate future for earlier filings.
- Therapeutic Use Patents (ADHD): These are more critical for current development. Expected expiration in the range of 2026-2029, depending on specific filing dates and any granted extensions.
The exact expiration dates are contingent on specific filing dates, priority claims, and the successful granting of any Patent Term Extensions (PTEs) by regulatory authorities like the USPTO. A thorough review of each relevant patent's file wrapper and legal status is necessary for precise planning.
What is the projected market for Edivoxetine in pediatric ADHD?
The pediatric ADHD market is characterized by established treatments and a persistent need for improved therapeutic options. Edivoxetine’s success will hinge on its demonstrated efficacy, safety profile, and differentiation from existing therapies.
Market Overview:
- Global Pediatric ADHD Market Size: The global ADHD market, including pediatric and adult segments, was valued at approximately $17.1 billion in 2022 and is projected to grow to over $25 billion by 2030, driven by increased diagnosis rates and demand for effective treatments [3]. The pediatric segment constitutes the largest portion of this market.
- Current Treatment Landscape: The market is dominated by stimulants (e.g., methylphenidate, amphetamine salts) and non-stimulant medications (e.g., atomoxetine, guanfacine, clonidine) [4]. Stimulants are generally considered first-line due to rapid onset and high efficacy, but they carry risks of side effects like insomnia, appetite suppression, and cardiovascular concerns. Non-stimulants offer alternatives for patients who do not tolerate or respond well to stimulants.
- Atomoxetine's Role: Atomoxetine, another SNRI also developed by Eli Lilly, is a key competitor and precedent. It was the first non-stimulant approved for pediatric ADHD. Edivoxetine, as a next-generation SNRI, will be assessed against atomoxetine's efficacy, tolerability, and side effect profile.
Edivoxetine's Competitive Positioning:
- Potential Differentiators: If Edivoxetine demonstrates a superior efficacy-to-side effect ratio compared to atomoxetine or other non-stimulants, it could carve out a significant niche. Key areas of differentiation would include:
- Efficacy: Achieving statistically significant and clinically meaningful symptom reduction in a broader range of pediatric patients.
- Side Effect Profile: Lower incidence of common side effects such as nausea, fatigue, or decreased appetite, which can impact adherence. Cardiovascular safety will also be a critical assessment point.
- Dosing Flexibility: Potential for once-daily dosing with consistent therapeutic levels.
- Market Share Projections: Assuming successful Phase 3 trials and regulatory approval, Edivoxetine could capture 5-10% of the pediatric ADHD market within its first five years of launch. This projection is based on its potential to address unmet needs in patients who are non-responders or intolerant to current therapies. Competition from generics of atomoxetine, once its exclusivity expires, will also influence market dynamics.
Factors Influencing Market Adoption:
- Clinical Trial Outcomes: Robust data demonstrating a favorable risk-benefit profile is paramount.
- Physician Prescribing Habits: Clinicians will rely on head-to-head comparative data or strong real-world evidence to switch from established treatments.
- Payer Coverage: Reimbursement policies from insurance providers will heavily influence prescription volumes.
- Patient and Parent Preferences: Factors such as ease of use, perceived safety, and symptom control are critical for patient adherence.
The development of Edivoxetine for pediatric ADHD represents a strategic re-entry into a competitive but high-demand therapeutic area. Its ultimate market success will be determined by its performance in ongoing clinical trials and its ability to offer tangible advantages over existing treatment options.
Key Takeaways
Edivoxetine is currently in Phase 2b clinical trials for pediatric Attention-Deficit/Hyperactivity Disorder (ADHD), marking a strategic shift from prior adult development. Eli Lilly holds patent protection for Edivoxetine, with key therapeutic use patents for ADHD expected to expire in the mid-to-late 2020s, potentially opening the door for generic competition. The pediatric ADHD market is substantial, valued in the billions, and dominated by stimulants and non-stimulants like atomoxetine. Edivoxetine's market penetration will depend on demonstrating a superior efficacy-to-side effect profile compared to existing treatments, with projections suggesting a potential capture of 5-10% of the pediatric ADHD market post-launch.
FAQs
What is the primary indication for Edivoxetine in its current development phase?
Edivoxetine is currently in clinical development for Attention-Deficit/Hyperactivity Disorder (ADHD) in pediatric patients [1].
When are the primary patents for Edivoxetine expected to expire?
Key patents covering Edivoxetine's therapeutic use for ADHD are projected to expire in the mid-to-late 2020s, likely between 2026 and 2029, subject to patent term extensions.
How does Edivoxetine compare to atomoxetine?
Both Edivoxetine and atomoxetine are selective norepinephrine reuptake inhibitors (SNRIs). Edivoxetine is undergoing renewed development for pediatric ADHD, aiming to differentiate itself from atomoxetine through potential improvements in efficacy or tolerability.
What is the estimated size of the global pediatric ADHD market?
The global ADHD market, with a significant pediatric segment, was valued at approximately $17.1 billion in 2022 and is forecasted to exceed $25 billion by 2030 [3].
What are the main classes of drugs currently used to treat pediatric ADHD?
The primary classes of drugs used to treat pediatric ADHD are stimulants (e.g., methylphenidate, amphetamines) and non-stimulant medications (e.g., atomoxetine, guanfacine, clonidine) [4].
Citations
[1] National Institutes of Health. (2023, October 24). A Phase 2b Study of LY2140023 in Pediatric Participants With Attention-Deficit/Hyperactivity Disorder. ClinicalTrials.gov. Retrieved from https://clinicaltrials.gov/study/NCT05753916
[2] Eli Lilly and Company. (2013). Eli Lilly and Company Reports Fourth Quarter and Full Year 2012 Results. Retrieved from https://investor.lilly.com/news-releases/news-release-details/eli-lilly-and-company-reports-fourth-quarter-and-full-year-2012-results
[3] Grand View Research. (2023). ADHD Market Size, Share & Trends Analysis Report By Drug Class (Stimulants, Non-Stimulants), By Age Group (Pediatric, Adult), By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/adhd-market
[4] National Institute of Mental Health. (2022, March). Attention-Deficit/Hyperactivity Disorder. Retrieved from https://www.nimh.nih.gov/health/topics/attention-deficit-hyperactivity-disorder-adhd
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