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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 developed for diabetic peripheral neuropathic pain, diabetic peripheral neuropathy, and postherpetic neuralgia. It has been studied in Phase 2 clinical trials for these neuropathic pain conditions.
LX9211 is being developed by Lexicon Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LXRX.
LX9211 is in Phase 2 clinical development. It has completed three Phase 2 trials, including studies in diabetic peripheral neuropathic pain and postherpetic neuralgia. It is not approved by the FDA and remains investigational.
LX9211 has completed three Phase 2 trials: NCT04455633 in diabetic peripheral neuropathic pain with 319 participants, NCT04662281 in postherpetic neuralgia with 79 participants, and NCT06203002, a dose-ranging study in diabetic peripheral neuropathic pain with 496 participants.
No alternative names for LX9211 have been identified. It is known only by its developmental code name LX9211.