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Also known as LY3526318 ISA
LY3526318 · 3 trials · 4 indications
The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95 percent (%) credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine. Posterior mean change from baseline, 95 percent (%) credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
| Arm | Type | Description |
|---|---|---|
| LY3526318 | EXPERIMENTAL | Participants received 250 milligram (mg) of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo orally, once daily, for 8-weeks treatment period. |
| Name | Type | Description |
|---|---|---|
| LY3526318 | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
Inclusion Criteria: * Have a visual analog scale (VAS) pain value ≥40 and \<95 during screening. * Have a history of daily pain for at least 12 weeks based on participant report or medical history. * Have a body mass index \<40 kilograms per meter squared (kg/m²) (inclusive). * Are willing to maint...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 2 | PHASE3 | Camlipixant |
| Trevi Therapeutics, Inc. | TRVI | 1 | PHASE2 | Haduvio (nalbuphine ER) |
LY3526318 is an investigational small molecule being developed by Eli Lilly and Company for chronic pain. It has been studied in Phase 2 clinical trials in adults with chronic low-back pain, diabetic peripheral neuropathic pain, and osteoarthritis. It is not approved for any indication and remains in clinical development.
LY3526318 is being studied for the treatment of chronic pain conditions, specifically chronic low-back pain, diabetic peripheral neuropathic pain, and osteoarthritis. All of these are investigational uses in Phase 2 clinical development, and the drug has not been approved for any indication.
LY3526318 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the Phase 2 chronic pain master protocol studies that evaluated the drug across multiple pain indications in the United States and Puerto Rico.
LY3526318 is in Phase 2 development. Three Phase 2 trials under a chronic pain master protocol have been completed, and the drug is investigational. It has not been approved by the FDA or any other regulatory agency for chronic low-back pain, diabetic peripheral neuropathic pain, or osteoarthritis.
Three completed Phase 2 trials have evaluated LY3526318: NCT05177094 in diabetic peripheral neuropathic pain, NCT05086289 in chronic low back pain, and NCT05080660 in osteoarthritis. All were randomized, double-blind, placebo-controlled studies conducted in the United States and Puerto Rico under a chronic pain master protocol.
Yes, LY3526318 ISA is an alternative name for LY3526318, the investigational small molecule developed by Eli Lilly and Company for chronic pain. Both names refer to the same compound studied in Phase 2 trials for chronic low-back pain, diabetic peripheral neuropathic pain, and osteoarthritis.