Not specified in extract Not specified in extract
Not specified in extract (Nasdaq: Not specified in extract) is a pain/anesthesia drug developer. Its lead program, onzotrigine, is in Phase 3 for moderate to severe acute pain, including postoperative pain. Its next catalyst on record is onzotrigine: Initiate placebo-controlled Phase 3 trial in bunionectomy and open-label Phase 3 safety trial (H2 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: onzotrigine — Initiate placebo-controlled Phase 3 trial in bunionectomy and open-label Phase 3 safety trial (H2 2026). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| onzotrigine | moderate to severe acute pain | small molecule | Phase 3 |
| LTG-321 | chronic musculoskeletal pain (osteoarthritis of the knee) | small molecule | Phase 2 |
| LTG-418 | acute and chronic pain | small molecule | Pre-clinical |
| onzotrigine IV formulation | hospital-setting postoperative pain | small molecule | Pre-clinical |
Recent results and decisions
- Sep 3, 2026met NEJM published abdominoplasty trial: met primary endpoint (SPID48 vs placebo) with high statistical significance.
The study met its primary endpoint of the Summed Pain Intensity Difference over 48 hours versus placebo with high statistical significance and demonstrated rapid, clinically meaningful pain relief, favorable tolerability, and opioid-sparing potential.
Filing - Sep 3, 2026started Initiated randomized, placebo-controlled crossover Phase 2 trial of LTG-321 in ~120 knee OA patients in Denmark.
Initiated a randomized, double-blind, placebo-controlled, within-patient crossover Phase 2 clinical trial of LTG-321 in approximately 120 patients with osteoarthritis of the knee, evaluating the safety and efficacy of once-daily LTG-321.
Filing - Sep 3, 2026n/a Naomi Lowy, M.D., former FDA deputy director, appointed as senior vice president of global regulatory affairs.
Further strengthened leadership team to support the next phase of growth with the appointment of Naomi Lowy, M.D., as senior vice president of global regulatory affairs.
Filing
1 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 pain/anesthesia companies
- Mesoblast Ltd MESO
- Scilex Holding Co SCLX
- Ensysce Biosciences, Inc. ENSC
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.