Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AGN-199201 · 4 trials · 3 indications
The investigator assessed the patient's overall severity of erythema in the treatment area on the 5 point CEA scale (ranging from 0=clear skin with no signs of erythema to 4=severe erythema/fiery redness). The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) on both CEA and SSA from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.
UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved.
UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved.
UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved. The percentages of patients with at least a 2 or more line improvement in UNVA in the non-dominant eye are presented.
| Arm | Type | Description |
|---|---|---|
| AGN-199201 | EXPERIMENTAL | AGN-199201 applied to the face once daily for 29 days. |
| Vehicle | PLACEBO_COMPARATOR | Vehicle to AGN-199201 applied to the face once daily for 29 days. |
| Cohort 1: Vehicle Control | EXPERIMENTAL | Vehicle dosed in both eyes administered once daily during office visits 1 through 5. |
| Cohort 2: AGN-199201 Dose A and AGN-190584 Dose A | EXPERIMENTAL | Fixed combinations of AGN-199201 Dose A and AGN-190584 Dose A dosed in both eyes administered once daily during office visits 1 through 5. |
| Cohort 3: AGN-199201 Dose B and AGN-190584 Dose B | EXPERIMENTAL | Fixed combinations of AGN-199201 Dose B and AGN-190584 Dose B dosed in both eyes administered once daily during office visits 1 through 5. |
| Cohort 4: AGN-199201 Dose C and AGN-190584 Dose C | EXPERIMENTAL | Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in both eyes administered once daily during office visits 1 through 5. |
| Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C | EXPERIMENTAL | Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5. |
| AGN-199201 and AGN-190584 Vehicle | EXPERIMENTAL | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
| AGN-199201 and AGN-190584 Dose A | EXPERIMENTAL | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
| AGN-199201 and AGN-190584 Dose B | EXPERIMENTAL | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
| AGN-199201 and AGN-190584 Dose C | EXPERIMENTAL | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
| AGN-190584 | EXPERIMENTAL | 1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. |
| AGN-199201 + AGN-190584 in One Eye | EXPERIMENTAL | 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. |
| AGN-199201 + AGN-190584 in Both Eyes | EXPERIMENTAL | 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each. |
| Name | Type | Description |
|---|---|---|
| AGN-199201 | DRUG | AGN-199201 applied to the face once daily for 29 days. |
| Vehicle to AGN-199201 | DRUG | Vehicle to AGN-199201 applied to the face once daily for 29 days. |
| AGN-199201 ophthalmic solution | DRUG | 1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye. |
| AGN-190584 ophthalmic solution | DRUG | 1 drop of AGN-190584 ophthalmic solution Doses A, B, C in the eye. |
| AGN-199201 Vehicle | DRUG | Vehicle to AGN-199201 |
| AGN-190584 Vehicle | DRUG | Vehicle to AGN-190584 |
| AGN-199201 + AGN-190584 Combination | DRUG | 1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye. |
| AGN-190584 | DRUG | 1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol. |
Inclusion Criteria: -Moderate to severe persistent facial erythema associated with rosacea. Exclusion Criteria: * Greater than 3 inflammatory lesions on the face * Current treatment with monoamine oxidase (MAO) inhibitors * Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scler...
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AGN-199201 is an investigational small molecule being developed for erythema associated with rosacea and for presbyopia. It is being studied for persistent erythema in rosacea patients and for presbyopia, typically in combination with AGN-190584.
AGN-199201 is being developed by AbbVie Inc. (NYSE: ABBV). AbbVie is the sponsor of the clinical trials for this investigational drug.
AGN-199201 is in Phase 3 clinical development for erythema associated with rosacea. It has also been studied in Phase 2 trials for presbyopia. The drug is investigational and not yet approved by regulatory authorities.
AGN-199201 has been studied in three completed trials. NCT02131636 was a Phase 3 trial in 440 patients with persistent erythema associated with rosacea. NCT02197806, NCT02595528, and NCT02780115 were Phase 2 trials in presbyopia, often combined with AGN-190584.
No, AGN-199201 is not the same as AGN-190584. They are distinct investigational drugs that have been studied together in clinical trials for presbyopia. AGN-199201 is also being studied alone for erythema associated with rosacea.