Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3526318 · 5 trials · 5 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.
Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318
Part B - MAD, PK: Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC\[0-tau \]) of LY3526318
CA-induced DBF was measured by laser doppler imaging (LDI). Least Squares (LS) mean was determined by analysis of variance (ANOVA) model with treatment, period, sequence, time and treatment\*time interaction as fixed factors and subject within sequence as a random factor.
| 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. |
| LY3526318 (Part A) | EXPERIMENTAL | 250 mg, 100 milligram (mg) LY3526318 administered orally as single ascending doses under fasted or fed condition. |
| LY3526318 (Part B) | EXPERIMENTAL | 250 mg LY3526318 administered orally as multiple doses under fasted or fed condition. |
| Placebo (Part A) | PLACEBO_COMPARATOR | Placebo administered orally under fasted or fed condition. |
| Placebo (Part B) | PLACEBO_COMPARATOR | Placebo administered orally under fasted or fed condition. |
| 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...
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LY3526318 is an investigational small molecule being studied for the treatment of pain conditions, including chronic low-back pain, diabetic peripheral neuropathic pain, and osteoarthritis. It has been evaluated in clinical trials for these indications, though it remains in clinical development and is not yet approved.
LY3526318 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The company has sponsored clinical trials of LY3526318 in healthy participants and in patients with chronic pain conditions.
LY3526318 has completed Phase 2 clinical trials for chronic low-back pain and diabetic peripheral neuropathic pain. It has also completed Phase 1 trials in healthy participants. The drug is investigational and remains in clinical development, with no approved indications.
LY3526318 has been studied in several completed trials, including NCT04183283 and NCT04682119 in healthy participants, NCT05086289 in chronic low-back pain, and NCT05177094 in diabetic peripheral neuropathic pain. These trials were randomized, double-blind, and placebo-controlled, with a total enrollment of about 160 participants across all studies.
LY3526318 is the primary identifier for this investigational compound developed by Eli Lilly. No alternative names have been established for this drug in the available clinical trial information. It is distinct from other pain medications and is being studied specifically for chronic pain conditions.