Approval Probability
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Adjusted LOA
ML Risk
Also known as GLPG1972 single ascending doses, GLPG1972 fed, GLPG1972 film-coated tablets, GLPG1972 film-coated, [14C]-GLPG1972 solution for infusion, GLPG1972 for infusion, [14C]-GLPG1972 oral solution, GLPG1972 - B
GLPG1972 · 3 trials · 1 indication
Reduction in cartilage loss was assessed by cartilage thickness as measured in the medial cMTFC of the target knee using qMRI.
To assess safety and tolerability of GLPG1972 in OA patients
To assess safety and tolerability of GLPG1972 in OA patients
To assess safety and tolerability of GLPG1972 in OA patients
To assess safety and tolerability of GLPG1972 in OA patients
To assess safety and tolerability of GLPG1972 in OA patients
To assess safety and tolerability of GLPG1972 in OA patients
To assess PK of GLPG1972 in OA patients
To assess PK of GLPG1972 in OA patients
To assess PK of GLPG1972 in OA patients
To assess PK of GLPG1972 in OA patients
To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast
To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast
To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast
To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast
To study the pharmacokinetics of 600 mg GLPG1972 administered as oral liquid solution or as oral tablet after overnight fasting or administered as oral tablet after a high-fat high calorie breakfast
To evaluate safety and tolerability of single oral doses of GLPG1972
To evaluate safety and tolerability of single oral doses of GLPG1972
To evaluate safety and tolerability of single oral doses of GLPG1972
To evaluate safety and tolerability of single oral doses of GLPG1972
To evaluate safety and tolerability of single oral doses of GLPG1972
| Arm | Type | Description |
|---|---|---|
| GLPG1972 75 mg | EXPERIMENTAL | Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks. |
| GLPG1972 150 mg | EXPERIMENTAL | Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks. |
| GLPG1972 300 mg | EXPERIMENTAL | Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks. |
| GLPG1972 | EXPERIMENTAL | - |
| GLPG1972 600 mg oral solution fasted | EXPERIMENTAL | 600 mg GLPG1972 administered as oral solution after overnight fasting |
| GLPG1972 600 mg oral tablet fasted | EXPERIMENTAL | 600 mg GLPG1972 administered as oral tablet after overnight fasting |
| GLPG1972 600 mg oral tablet fed | EXPERIMENTAL | 600 mg GLPG1972 administered as oral tablet after a high-fat high-calorie breakfast |
| Name | Type | Description |
|---|---|---|
| GLPG1972 | DRUG | Film-coated tablets of GLPG1972 for oral use. |
| Placebo | DRUG | Film-coated tablets of matching placebo for oral use. |
| GLPG1972 cohort 1 | DRUG | GLPG1972 dose 1 provided as oral tablets q.d. |
| GLPG1972 cohort 2 | DRUG | GLPG1972 dose 2 provided as oral tablets q.d. |
| GLPG1972 cohort 3 | DRUG | GLPG1972 dose 3 provided as oral tablets q.d. |
| GLPG1972 600 mg oral solution fasted | DRUG | dosing after overnight fasting |
| GLPG1972 600 mg oral tablet fasted | DRUG | dosing after overnight fasting |
| GLPG1972 600 mg oral tablet fed | DRUG | dosing after high-fat high-calorie breakfast |
Inclusion Criteria: * Male participants or female participants of non-childbearing potential and not breastfeeding. * Body weight \> 40 kg, body mass index (BMI) \< 40 kg/m\^2. * Diagnosed for knee osteoarthritis based on clinical and radiological criteria of the American College of Rheumatology. *...
Top 5 of 14 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 4 | PHASE3 | Orforglipron, Eloralintide, LY3016859, LY3556050, LY3526318 |
| Pacira Biosciences, Inc. | PCRX | 4 | PHASE3 | ZILRETTA, Enekinragene Inzadenovec, FX201 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 2 | PHASE3 | NNC0487-0111 |
| Bioventus, Inc. Class A | BVS | 1 | PHASE2 | PTP-001 |
| Enlivex Ltd. | ENLV | 2 | PHASE1 | Allocetra |
GLPG1972 is an investigational small molecule being studied for the treatment of osteoarthritis, a musculoskeletal condition. It has been evaluated in clinical trials involving participants with knee osteoarthritis. GLPG1972 has not been approved for any indication and remains in clinical development.
GLPG1972 is being developed by Lakefront Biotherapeutics, which trades under the ticker LKFT. The company has sponsored the clinical trial program for the drug in osteoarthritis, including Phase 1 and Phase 2 studies conducted in the United States and the Netherlands.
GLPG1972 is in Phase 2 development. Its Phase 2 trial, NCT03595618, evaluated efficacy and safety in participants with knee osteoarthritis and has been completed. Two earlier Phase 1 trials, NCT03311009 and NCT02851485, have also been completed. GLPG1972 is investigational and has not been approved by the FDA.
GLPG1972 has been studied in three completed clinical trials: NCT03595618, a Phase 2 efficacy and safety study in knee osteoarthritis with 932 participants; NCT03311009, a Phase 1 study in osteoarthritis subjects with 30 participants; and NCT02851485, a Phase 1 bioavailability study with 12 healthy male volunteers.
Across its three completed clinical trials, GLPG1972 has enrolled a total of 974 participants. The largest study, the Phase 2 trial NCT03595618 in knee osteoarthritis, enrolled 932 participants. The program includes randomized, double-blind, controlled trial designs.