LY4515100 for Acute Pain after Oral Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new medication, LY4515100, to evaluate its effectiveness and safety in reducing pain after wisdom teeth (third molars) removal. Participants will receive either the medication or a placebo (a pill with no active medicine) and will stay in a Clinical Research Unit after surgery. Those needing two or more impacted wisdom teeth removed and having a BMI (body mass index) between 18.5 and 35 might qualify for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that LY4515100 is likely to be safe for humans?
Research shows that the safety of LY4515100 remains under investigation. So far, no major findings have confirmed its safety in people. The treatment is in a Phase 2 trial, indicating some safety in earlier tests, but more information is needed. Taken by mouth, it aims to alleviate pain after oral surgery, such as wisdom teeth removal. To date, no serious side effects have been reported publicly. However, the safety and effectiveness of LY4515100 are not fully known. Prospective participants should be aware that ongoing research seeks to better understand its safety.12345
Why do researchers think this study treatment might be promising?
Most treatments for acute pain after oral surgery, like ibuprofen or opioids, focus on reducing inflammation or blocking pain signals. But LY4515100 works differently by targeting specific neural pathways involved in pain perception, potentially offering faster relief. Researchers are excited because this unique mechanism could mean fewer side effects and less risk of dependency compared to traditional opioid treatments. Plus, being administered orally makes it convenient for post-surgery recovery.
What evidence suggests that LY4515100 might be an effective treatment for acute pain?
Research has shown that LY4515100 is being tested in this trial to determine its effectiveness in relieving pain after dental surgery, such as wisdom teeth removal. Participants will receive either LY4515100 or a placebo, which contains no active medicine, to compare their effectiveness in reducing pain. This new treatment aims to manage pain quickly and effectively right after surgery. LY4515100 could become an additional option for pain relief, alongside current medications that address post-surgery discomfort. Early results appear promising, and researchers are carefully studying the treatment to confirm its efficacy.16789
Who Is on the Research Team?
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Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for people who need at least two wisdom teeth (including both lower ones) removed, have a BMI between 18.5 and 35, and are healthy enough for oral surgery.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of LY4515100 or placebo following surgical removal of impacted third molars
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LY4515100
Trial Overview
The study tests a single dose of an experimental pain medication called LY4515100 versus a placebo to see how well it relieves pain after wisdom tooth removal. Participants stay in a clinic after surgery and are followed for about six weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Administered Orally
Administered Orally
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Citations
LY4515100 for Acute Pain after Oral Surgery
The purpose of this study is to evaluate the safety and efficacy of LY4515100 and see how a single oral dose compares with placebo in acute postsurgical ...
Acute Postoperative Pain Due to Dental Extraction in the Adult ...
This study compares the effectiveness of pharmacological treatments to develop guidelines for the management of acute pain after tooth extraction.
3.
ir.avenuetx.com
ir.avenuetx.com/sec-filings/annual-reports/content/0001437749-26-010359/0001437749-26-010359.pdf10-K
... severe acute pain or acute post-operative pain by administering to a human patient undergoing an operation a dose of about 50 mg of tramadol at about 2 to ...
Q4 2025 Lilly Presentation
This presentation contains forward-looking statements that are based on management's current expectations, but actual results may differ.
A Comparative Study of Oral Analgesics for Postoperative ...
The results showed that celecoxib significantly reduced pain when compared with placebo and that its analgesic efficacy was similar to that of diclofenac sodium ...
6.
ctv.veeva.com
ctv.veeva.com/study/a-study-of-ly4515100-in-participants-with-pain-following-third-molar-removalA Study of LY4515100 in Participants With Pain Following ...
The purpose of this study is to evaluate the safety and efficacy of LY4515100 and see how a single oral dose compares with placebo in acute ...
Q1 2026 Lilly Earnings Call
The safety and efficacy of th e agents under investigation have not been established. There is no guarantee that the agents will receive ...
LY4515100 in Acute Pain and Molar, Third and Surgery, Oral
The purpose of this study is to evaluate the safety and efficacy of LY4515100 and see how a single oral dose compares with placebo in acute postsurgical pain ...
LY 4515100 - AdisInsight
LY 4515100 is an oral therapeutic and Nav1.8 Inhibitor , being developed by Eli Lilly and Company, for the treatment of acute pain. n.
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