Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mim8 · 2 trials · 3 indications
Measured as count of events.
Measured as count of events.
Count of events
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Participants entering from the multiple ascending dose (MAD) part of study NN7769-4513. In part 1, participants will receive Mim8 prophylaxis (PPX) subcutaneous (s.c.) administration using enhanced cartridge for 26 weeks. In part 2, participants will receive Mim8 PPX s.c. administration using enhanced cartridge or DV3407 pen-injector once it is approved. |
| Arm 2 | EXPERIMENTAL | Participants entering from study NN7769-4514, NN7769-4728 and NN7769-4516. In part 1, participants will receive Mim8 PPX s.c. administration using DV3407 pen-injector for 26 weeks. In part 2, participants will receive Mim8 PPX s.c. administration using DV3407 pen-injector. |
| Arm 3 | EXPERIMENTAL | In part 1 and 2, participants will receive Mim8 PPX s.c. administration using DV3407 pen-injector. |
| Mim8 | EXPERIMENTAL | 52-week treatment period with a part 1 and part 2, where all participants receive Mim8 prophylaxis |
| Name | Type | Description |
|---|---|---|
| Mim8 | DRUG | Participants in arm 1 will administer Mim8 using an enhanced cartridge and switch to the DV3407 pen-injector once it is approved. Participants in arm 2 and 3 will use the DV3407 pen injector. |
Arm 1 \& 2: Inclusion Criteria: 1. Informed consent obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. 2. Male or female with diagnosis of congenital haemo...
Mim8 is an investigational small molecule being developed for the treatment of haemophilia A, including haemophilia A with or without inhibitors. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
Mim8 is a small molecule designed to address haemophilia A, a bleeding disorder. Its specific molecular target has not been disclosed in available clinical trial information, and its mechanism of action is not publicly detailed.
Mim8 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy in patients with haemophilia A.
Mim8 is currently in Phase 3 clinical development. It is an investigational drug and has not received approval from regulatory agencies. Clinical trials are ongoing to assess its long-term treatment effects in people with haemophilia A.
Mim8 is being studied in two Phase 3 trials. NCT05306418 is a completed study in children with haemophilia A with or without inhibitors, enrolling 70 participants. NCT05685238 is a recruiting study on long-term treatment in 451 people with haemophilia A, including those with inhibitors.
No alternative names for Mim8 have been reported in the clinical trial information. It is referred to solely as Mim8 in the context of its development for haemophilia A.