Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as DRM01B
Olumacostat Glasaretil · 4 trials · 1 indication
Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12
Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12
Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12 Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions 1. \- Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion 2. \- Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions) 3. \- Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion 4. \- Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions
Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12 in Phase 2a
Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12 in Phase 2a
Percentage of subjects who achieved ≥ 2-grade improvement in the investigator global assessment of acne (IGA) from baseline to Week 12 in Phase 2a Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions 1. \- Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion 2. \- Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions) 3. \- Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion 4. \- Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions
| Arm | Type | Description |
|---|---|---|
| Olumacostat Glasaretil Gel, 5.0% | EXPERIMENTAL | Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks |
| Olumacostat Glasaretil Gel, Vehicle | PLACEBO_COMPARATOR | Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks |
| Olumacostat Glasaretil Gel, Vehicle QD | PLACEBO_COMPARATOR | Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks |
| Olumacostat Glasaretil Gel, Vehicle BID | PLACEBO_COMPARATOR | Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks |
| Olumacostat Glasaretil Gel, 4.0% QD | EXPERIMENTAL | Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks |
| Olumacostat Glasaretil Gel, 7.5% QD | EXPERIMENTAL | Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks |
| Olumacostat Glasaretil Gel, 7.5% BID | EXPERIMENTAL | Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks |
| Phase 1 | EXPERIMENTAL | Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 7 days in healthy volunteers |
| Phase 2a | EXPERIMENTAL | Olumacostat Glasaretil Gel, 7.5%, or Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Olumacostat Glasaretil Gel, 5.0% | DRUG | Gel containing Olumacostat Glasaretil |
| Olumacostat Glasaretil Gel, Vehicle | OTHER | Vehicle (placebo) gel |
| Olumacostat Glasaretil | DRUG | - |
| Vehicle | OTHER | - |
| Olumacostat Glasaretil Gel, 7.5% | DRUG | Gel containing Olumacostat Glasaretil |
Inclusion Criteria: * Signed informed consent and, for subjects under legal adult age, signed assent * Age ≥ 9 years * Clinical diagnosis of facial acne vulgaris defined as: * At least 20 inflammatory lesions, and * At least 20 non-inflammatory lesions, and * Investigator Global Assessment o...
Olumacostat glasaretil, 7.5% is a topical small-molecule gel being developed for acne vulgaris. It is applied to the skin and is formulated at a 7.5% strength. Eli Lilly and Company is developing it, and it has been studied in Phase 3 clinical trials in patients with acne.
Olumacostat glasaretil is being developed for the treatment of acne vulgaris. All four of its clinical trials enrolled participants with acne vulgaris, including two Phase 3 studies conducted in the United States, Australia, and Canada. It is a topical gel rather than an oral treatment.
Olumacostat glasaretil inhibits ACACA and ACACB, two acetyl-CoA carboxylase enzymes. By targeting these enzymes, the drug is designed to interfere with fatty acid synthesis in the skin, which is relevant to sebum production in acne. It is a small-molecule inhibitor delivered as a topical gel.
Eli Lilly and Company, ticker LLY, is developing olumacostat glasaretil. The compound was studied earlier under the designation DRM01 and DRM01B before advancing into Phase 3 trials under the olumacostat glasaretil name. Lilly holds the development program for the topical acne gel.
Olumacostat glasaretil has reached Phase 3 clinical development for acne vulgaris. Two Phase 3 trials, NCT03073486 and NCT03028363, have been completed. The program also includes a completed Phase 2 dose-ranging study and a completed Phase 1/Phase 2 safety and tolerability study. It is investigational and not approved.
Olumacostat glasaretil has been studied in four completed trials: Phase 3 studies NCT03073486 and NCT03028363, the Phase 2 dose-ranging study NCT02431052, and the Phase 1/Phase 2 study NCT01936324. Together these trials enrolled about 2,037 participants, and the Phase 3 studies were randomized, double-blind, and placebo-controlled.
Yes, DRM01 and DRM01B are earlier designations for olumacostat glasaretil. The Phase 2 dose-ranging trial NCT02431052 and the Phase 1/Phase 2 study NCT01936324 used the DRM01 names, while the later Phase 3 trials used olumacostat glasaretil. The alternative names also include the 5.0% gel formulation.