Approval Probability
TA Base Rate
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ML Risk
Also known as NR082 Injection
NR082 · 1 trial · 1 indication
Incidence of adverse events (AEs) within 52 weeks of NR082 intravitreal injection at different doses
Incidence of serious adverse events (SAEs)within 52 weeks of NR082 intravitreal injection at different doses
Incidence of dose-limiting toxicities (DLT) (ocular and non-ocular) within 52 weeks of NR082 intravitreal injection at different doses
| Arm | Type | Description |
|---|---|---|
| NR082 injection | EXPERIMENTAL | Potential doses at the dose-finding stage: * 0.5E9 vg, 0.05 mL/eye/dose (low dose) * 1.5E9 vg, 0.05 mL/eye/dose (starting dose) * 3.0E9 vg, 0.05 mL/eye/dose (intermediate dose) * 4.5E9 vg, 0.05 mL/eye/dose (high dose) |
| Name | Type | Description |
|---|---|---|
| NR082 Injection | DRUG | The starting dose is 1.5E9 vg, 0.05 mL eye/dose. Dose Escalation: If drug-related dose-limiting toxicity (DLT) events are observed in ≤ 2 of the 6 evaluable subjects using the starting dose within 6 weeks after the dosing of NR082, the dose can be escalated to 4.5E9 vg, 0.05 mL eye/dose (high dose) after approval by SRC. Dose De-escalation： If drug-related dose-limiting toxicity (DLT) events are observed in \> 2 of the 6 evaluable subjects using the starting dose within 6 weeks after the dosing of NR082, the dose can be de-escalated to 0.5E9 vg, 0.05 mL eye/dose (low dose) after approval by SRC. If drug-related dose-limiting toxicity (DLT) events are observed in \> 2 of the 6 evaluable subjects within 6 weeks after the dosing of NR082 at the high dose, the dose can be de-escalated to 3.0E9 vg, 0.05 mL eye/dose (intermediate dose) after the approval by SRC. |
| Injection needle | DEVICE | 19G 1 1/2IN TW filter needle with filter element (BD 305200)，used to NR082 Intraocular injection solution dose preparation; 30G 1/2IN injection needle (BD 305106)，used to NR082 Intraocular injection solution administration; 1 ml screw top syringe (BD 309628),used to NR082 Intraocular injection solution dose preparation and administration. |
Inclusion Criteria: 1. Age at the time of signing the informed consent form: the age of the subjects must be ≥ 18 years old and ≤ 75 years old. 2. The clinical manifested vision loss due to LHON, and any eye BCVA ≥ 0.5 LogMAR 3. The genotype testing result shows the presence of G11778A mutation in ...
NR082 is an investigational small molecule being developed for the treatment of Leber Hereditary Optic Neuropathy (LHON), a rare inherited condition that causes vision loss. It is currently in Phase 1 clinical development and is not yet approved by the FDA.
NR082 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The drug is in Phase 1 clinical trials for the treatment of Leber Hereditary Optic Neuropathy (LHON).
NR082 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA and is still being studied for safety and efficacy in clinical trials for Leber Hereditary Optic Neuropathy (LHON).
NR082 is being studied in a Phase 1 clinical trial with the identifier NCT05293626. This active, non-recruiting trial is enrolling 12 participants in the United States to evaluate the treatment of Leber Hereditary Optic Neuropathy associated with ND4 mutations.
Yes, NR082 is also known as NR082 Injection. Both names refer to the same investigational drug being developed by cbdMD, Inc. for the treatment of Leber Hereditary Optic Neuropathy (LHON).