Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GZ389988 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| GZ389988 | EXPERIMENTAL | Single intraarticular injection of GZ389988 in the knee joint |
| Placebo | PLACEBO_COMPARATOR | Single intraarticular injection of placebo for GZ389988 in the knee joint |
| Name | Type | Description |
|---|---|---|
| placebo | DRUG | Pharmaceutical form:solvent for parenteral use Route of administration: intraarticular |
| GZ389988 | DRUG | Pharmaceutical form:suspension for injection Route of administration: intraarticular |
| acetaminophen or paracetamol | DRUG | Pharmaceutical form: tablet Route of administration: oral |
| fixed combination of paracetamol + codeine | DRUG | Pharmaceutical form: capsule Route of administration: oral |
| fixed combination of paracetamol + tramadol hydrochloride | DRUG | Pharmaceutical form: tablet Route of administration: oral |
Inclusion criteria : * Men or women 40 to 80 years of age. * Diagnosis of primary knee osteoarthritis (OA), based upon the following: * Fulfilling the American College of Rheumatology Clinical and Radiographic criteria for OA (at least knee pain and osteophytes), with * X-ray evidence within the la...
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 |
GZ389988 is an investigational small molecule developed by Sanofi for the treatment of osteoarthritis, specifically painful osteoarthritis of the knee. It is administered as a single intra-articular dose directly into the knee joint. It remains in clinical development and is not approved for any indication.
GZ389988 targets NTRK1, also known as tropomyosin receptor kinase A (TrkA). It is an inhibitor of this receptor. NTRK1 is a neurotrophin receptor involved in pain signaling, which is the rationale for testing the compound in painful knee osteoarthritis.
GZ389988 is being developed by Sanofi, the French multinational pharmaceutical company listed on the Nasdaq under the ticker SNY. Sanofi sponsored both clinical trials of the compound conducted to date.
GZ389988 has completed Phase 2 development. Its Phase 2 proof-of-concept trial evaluated a single intra-articular dose versus placebo in patients with painful osteoarthritis of the knee. The drug is investigational and has not been approved by the FDA or any other regulatory authority.
GZ389988 has been studied in two completed trials: NCT02424942, a first-in-human Phase 1 study of ascending single intra-articular doses, and NCT02845271, a Phase 2 proof-of-concept study comparing a single intra-articular dose against placebo. Both enrolled patients with painful osteoarthritis of the knee in Germany, with 28 and 104 participants respectively.