Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Amniotic Suspension Allograft
Amniotic Allograft · 2 trials · 1 indication
| Name | Type | Description |
|---|---|---|
| Amniotic Suspension Allograft | BIOLOGICAL | This investigational product is a cryopreserved product derived from human amnion and cells from the amniotic fluid. |
| Placebo | DRUG | Matching placebo is 0.9% normal saline: 4 mL to be injected IA. |
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 |
Amniotic Allograft is being developed for the treatment of knee osteoarthritis, a degenerative joint condition. It is an amniotic tissue-based product studied in patients with osteoarthritis of the knee. The program is in late-stage development, with two completed Phase 3 trials in this indication.
Amniotic Allograft is developed by Organogenesis Holdings Inc., which trades on the Nasdaq under the ticker ORGO. The company is the sponsor of the clinical program evaluating the product in knee osteoarthritis.
Amniotic Allograft is in the NDA/BLA stage of development, meaning the program has advanced beyond clinical trials toward the regulatory submission phase. It is investigational and has not been approved. Two Phase 3 trials in knee osteoarthritis have been completed.
Two completed Phase 3 trials have evaluated Amniotic Allograft in knee osteoarthritis: NCT06000410, which enrolled 594 patients, and NCT04636229, which enrolled 516 patients. Together the trials enrolled 1,110 participants. Both studies are listed as completed, and no trials are currently active.
Yes. Amniotic Allograft is also known as Amniotic Suspension Allograft. The two names refer to the same product candidate being developed by Organogenesis Holdings Inc. for knee osteoarthritis, so searches using either name point to the same asset and clinical program.