 | |
| Clinical data | |
|---|---|
| Other names | JZP386; C-10323; C10323; d4-Sodium oxybate; Deuterated sodium oxybate; Deuterated oxybate; Deuterated μ-hydroxybutyrate; Deu-GHB |
| Routes of administration | Oral[1] |
| Drug class | GABAB receptoragonist;GHB receptoragonist;Hypnotic |
| ATC code |
|
| Identifiers | |
| CAS Number | |
| Chemical and physical data | |
| Formula | C4H8NaO3 |
| Molar mass | 127.095 g·mol−1 |
JZP-386, also known asdeuterated sodium oxybate,deuterated γ-hydroxybutyrate (deu-GHB), ord4-sodium oxybate, is adeuteratedanalogue ofsodium oxybate (γ-hydroxybutyrate; GHB) which is under development for the treatment ofnarcolepsy.[1][2][3][4][5] It is takenorally.[1] In aclinical study, JZP-386 showed greater circulating levels and correspondingly stronger effects than sodium oxybate.[3][4] The drug was originated by Concert Pharmaceuticals (now part ofSun Pharmaceutical Industries) and is under development byJazz Pharmaceuticals.[1][2] As of March 2023, no recent development has been reported.[1] JZP-386 reachedphase 1clinical trials by 2014.[1][2] It was said that the enhanced properties of JZP-386 were insufficient to support further clinical development and other avenues are instead being explored.[3][4] There was also interest in JZP-386 for the potential treatment offibromyalgia.[4]
3.17. Deuterated Sodium Oxybate (JZP-386) Deuterated sodium oxybate, a kind of dopamine receptor agonist, is a deuterated analog of sodium oxybate developed by CoNCERT and Jazz Pharmaceuticals for the treatment of narcolepsy and fibromyalgia.[85,86] The deuteration process improves the pharmaceutical properties of the drug. According to the results of a phase I trial which applies JZP-386 to thirty healthy volunteers, JZP-386 displays increased serum concentrations and correspondingly higher pharmacodynamic effects compared to sodium oxybate (Xyrem). However, the enhanced characteristics observed in the phase I trial are insufficient to support JZP-386 to enter further clinical trials and therefore the companies are exploring differentiated formulations to enhance the positive effects of deuteration in JZP-386.[86]
JZP-386 is a lead compound in a series of deuterium containing analog of sodium oxybate, under development for improved product characteristics (enhanced safety, tolerability and efficacy) for treatment of narcolepsy and fibromyalgia. A phase 1, randomized, single center, single ascending dose, crossover, first-in-humans trial in 28 healthy subjects in Europe, was recently undertaken.106 The Phase 1 study evaluated the safety, pharmacokinetics and pharmacodynamics (PD) of JZP-386 in 30 healthy volunteers. Clinical data from this Phase 1 study demonstrated that JZP-386 provided favorable deuterium-related effects, including higher serum concentrations and correspondingly increased PD effects at clinically relevant time points compared to sodium oxybate oral solution. The safety profile of JZP-386 was similar to that observed with Xyrem. Per press release, the deuterium-related effects observed in the Phase 1 studies did not support advancing into a later-stage clinical trial of JZP-386 at the present time. Accordingly, the companies intend to explore formulation options to enhance the positive effects observed in the studies to achieve an improved product profile for patients with narcolepsy.107
d4-sodium oxibate, 81 (JZP-386) [...]
 | Thisdrug article relating to thenervous system is astub. You can help Wikipedia byadding missing information. |