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Also known as NKTR-181 BID tablets
NKTR-181 · 3 trials · 3 indications
Count of subjects reporting treatment emergent adverse events
The daily pain intensity is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).
The first phase of this trial involved an open-label titration period where patients were given NKTR-181 at increasing doses up to a maximum of 400 mg twice daily until adequate pain control was achieved. Patients achieving adequate pain control were then progressed to the second phase of the trial where patients were randomized in a 1:1 ratio to receive either placebo or their tolerable dose level of NKTR-181. All efficacy data for NKTR-181 patients was combined into one group regardless of tolerable dose level. For this outcome, the subjects had to rate their worst pain intensity during the past 4 hours from 0 to 10 on an 11-point scale, where 0 represented one end of the continuum (i.e., no pain) and 10 represented the other extreme of pain intensity (i.e., worst pain imaginable).
| Arm | Type | Description |
|---|---|---|
| NKTR-181 | EXPERIMENTAL | NKTR-181 twice daily (BID) tablets |
| Placebo | PLACEBO_COMPARATOR | Placebo to match NKTR-181 twice daily (BID) tablets |
| 100 mg NKTR-181 | EXPERIMENTAL | 100 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days. |
| 200 mg NKTR-181 | EXPERIMENTAL | 200 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days. |
| 300 mg NKTR-181 | EXPERIMENTAL | 300 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days |
| 400 mg NKTR-181 | EXPERIMENTAL | 400 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days |
| Name | Type | Description |
|---|---|---|
| NKTR-181 BID tablets | DRUG | NKTR-181 tablets 100-600 mg twice daily (BID) |
| Placebo to match NKTR-181 BID tablets | DRUG | Placebo to match NKTR-181 tablets 100-400 mg twice daily (BID) |
| NKTR-181 | DRUG | - |
| Placebo | DRUG | Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181 |
Inclusion Criteria: * Male or non-pregnant, non-nursing female aged 18 to 75 years old * Clinical diagnosis of moderate to severe, chronic low back or non-cancer pain for at least three months * Not experiencing adequate pain relief or have failed previous treatment with non-opioid analgesics * Opi...
Top 1 of 5 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE2 | LY4065967 |
NKTR-181 is an investigational small molecule being developed for chronic pain, specifically chronic low back pain and osteoarthritis of the knee. It has been studied in Phase 3 clinical trials in patients with chronic low back pain and in a Phase 2 trial in patients with osteoarthritis of the knee.
NKTR-181 is being developed by Nektar Therapeutics, which trades on the Nasdaq under the ticker NKTR. Nektar is the sponsor of the clinical development program for NKTR-181.
NKTR-181 has completed Phase 3 clinical development. Two Phase 3 trials and one Phase 2 trial have been completed. The Phase 3 program enrolled 1,827 patients in randomized, double-blind, placebo-controlled studies.
NKTR-181 has been studied in three completed trials: NCT02367820, a Phase 3 long-term safety and tolerability study in chronic low back pain or chronic non-cancer pain; NCT02362672, a Phase 3 efficacy and safety study in opioid-naive subjects with low back pain; and NCT01619839, a Phase 2 study in chronic osteoarthritis of the knee pain.
Yes, NKTR-181 BID tablets is an alternative name for NKTR-181. Both refer to the same investigational small molecule developed by Nektar Therapeutics for chronic pain indications.