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Also known as LX9211 (blinded)
LX9211 · 3 trials · 4 indications
ADPS is based on the 11-point numerical rating scale (NRS) \[0 (no pain) to 10 (worst imaginable pain)\].
ADPS is based on question 5 of Zoster Brief Pain Inventory (ZBPI) and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine. Higher ADPS scores indicates a worse outcome. Negative change from baseline indicates no pain.
ADPS is based on question 5 of Brief Pain Inventory (BPI)-short form for Diabetic Peripheral Neuropathy (BPI-DPN) and is assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Higher ADPS scores indicate higher pain intensity. Negative change from baseline indicates improvement.
| Arm | Type | Description |
|---|---|---|
| LX9211 Low Dose | EXPERIMENTAL | LX9211 low dose, orally, once daily during a blinded treatment period. |
| LX9211 High Dose | EXPERIMENTAL | LX9211 high dose, orally, once daily during a blinded treatment period. |
| LX9211 High Dose Followed by Low Dose | EXPERIMENTAL | LX9211 high dose followed by LX9211 low dose, orally, once daily during a blinded treatment period. |
| LX9211 Placebo | PLACEBO_COMPARATOR | LX9211 matching placebo, orally, once daily during a blinded treatment period. |
| Placebo | PLACEBO_COMPARATOR | Following a 2-week Single-blind Run-in period, participants will receive a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6. |
| LX9211 | EXPERIMENTAL | Following a 2-week Single-blind Run-in period, participants will receive a single loading dose of 200 milligrams (mg) tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6. |
| LX9211 100 mg/10 mg | EXPERIMENTAL | Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 milligrams (mg), tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up. |
| LX9211 200 mg/20 mg | EXPERIMENTAL | Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up. |
| Name | Type | Description |
|---|---|---|
| Placebo (blinded) | DRUG | LX9211 matching placebo tablets |
| LX9211 (blinded) | DRUG | LX9211 (blinded) tablets |
| Placebo | DRUG | LX9211 matching-placebo, tablets will be administered orally. |
| LX9211 | DRUG | LX9211 tablets will be administered orally. |
| LX9211 Matching Placebo | DRUG | Oral Tablets |
Inclusion Criteria: 1. Participant has given written informed consent to participate in the study in accordance with local regulations 2. Adult male and female participants ≥18 years of age at the Screening Visit 3. Body mass index ≥18.0 to ≤40.0 kilogram per meter square (kg/m\^2) at Screening 4. ...
LX9211 is an investigational small molecule being studied for diabetic peripheral neuropathic pain, diabetic peripheral neuropathy, and postherpetic neuralgia. It is being developed by Lexicon Pharmaceuticals, Inc. (ticker: LXRX) and has completed Phase 2 clinical trials in these pain conditions.
LX9211 targets AAK1, also known as AP2-associated protein kinase 1. By inhibiting AAK1, LX9211 is designed to reduce neuropathic pain signaling. This mechanism is distinct from currently approved pain therapies and is being evaluated in clinical trials for diabetic peripheral neuropathic pain and postherpetic neuralgia.
LX9211 is being developed by Lexicon Pharmaceuticals, Inc., which trades under the ticker symbol LXRX. Lexicon is a biopharmaceutical company focused on discovering and developing innovative medicines for human disease.
LX9211 is in Phase 2 clinical development. It has completed three Phase 2 trials: NCT06203002 in diabetic peripheral neuropathic pain, NCT04662281 in postherpetic neuralgia, and NCT04455633 in diabetic peripheral neuropathic pain. It is not approved by the FDA and remains investigational.
LX9211 has been evaluated in three completed Phase 2 clinical trials. NCT06203002 was a dose-ranging study in diabetic peripheral neuropathic pain with 496 patients. NCT04662281 studied postherpetic neuralgia with 79 patients. NCT04455633 studied diabetic peripheral neuropathic pain with 319 patients. All trials were randomized, double-blind, and placebo-controlled.
Yes, LX9211 (blinded) refers to the same investigational drug as LX9211. The term blinded indicates that the drug was administered under blinded conditions in clinical trials, meaning participants and investigators did not know whether patients received LX9211 or placebo. It is not a different compound.