Melatonin oral gelAlternative Names: JAN-13004; SP-13004
Latest Information Update: 21 Oct 2015
At a glance
- Originator Spherium Biomed
- Class Hormones; Sleep disorder therapies; Tryptamines
- Mechanism of Action Undefined mechanism
Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
On Fast track
Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.
- New Molecular Entity No
Highest Development Phases
- Phase I/II Stomatitis
Most Recent Events
- 15 Mar 2016 Biomarkers information updated
- 02 Oct 2015 Phase-I/II clinical trials in Stomatitis (Chemotherapy-induced) in Spain (PO) (EudraCT2015-001534-13)