Drugs / MIV-711
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03443453 | Jan → Feb 2018 | — | Medivir | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT03037489 | Sep 2016 → Nov 2017 | osteoarthritis, knee | Medivir | Completed | Met primary |
| Phase 2 | NCT02705625 | Jan 2016 → May 2017 | osteoarthritis, knee | Medivir | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2025-11-27 | Medivir | Regulatory FDA grants Medivir´s MIV-711 Orphan Drug Designation for the treatment of Osteogenesis Imperfecta medivir.com ↗ |
| 2024-04-25 | Medivir | Regulatory FDA grants Medivir´s MIV-711 Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Legg-Calvé-Perthes Disease medivir.com ↗ |
| 2022-02-28 | Medivir | Results A subgroup analysis of Medivir´s phase II study of MIV-711 for osteoarthritis shows statistically significant reduction in OA pain medivir.com ↗
In a subgroup with predominantly unilateral knee pain, a statistically significant reduction in OA pain by MIV-711 treatment was found, with concurrent beneficial structural effects. |
| 2020-01-20 | Medivir | Results Medivir´s phase II study of MIV-711 in patients with osteoarthritis published in Annals of Internal Medicine medivir.com ↗
Medivir AB (Nasdaq Stockholm: MVIR) announces that the phase II study of MIV-711 in patients with osteoarthritis has been published in the respected journal Annals of Internal Medicine ( DOI: 10.7326/M19-0675). |
| 2019-05-06 | Medivir | Results Safety and efficacy data from the MIV-711 phase II open label extension study presented at the OARSI world congress medivir.com ↗
This study demonstrated that MIV-711 has acceptable safety and tolerability in knee osteoarthritis patients, with the overall safety profile in patients completing 12 months´ of treatment similar to that seen in the placebo-controlled study. |
| 2018-07-27 | Medivir | Results MIV-711 osteoarthritis phase IIa extension study outcomes show continuing positive effect on joint structure medivir.com ↗ |
| 2018-06-28 | Medivir | Results Medivir announces positive top-line results from the MIV-711 osteoarthritis phase IIa extension study medivir.com ↗
Medivir AB (Nasdaq Stockholm: MVIR) today announced positive top-line results from the MIV-711 phase IIa extension study (MIV-711-202). |
| 2018-04-26 | Medivir | Results Data from the MIV-711 initial phase IIa study will be presented at the OARSI World Congress on April 27 medivir.com ↗
SIX MONTHS’ TREATMENT WITH MIV-711, A NOVEL CATHEPSIN K INHIBITOR INDUCES OSTEOARTHRITIS STRUCTURE MODIFICATION: RESULTS FROM A RANDOMIZED DOUBLE BLIND PLACEBO-CONTROLLED PHASE IIA TRIAL |
| 2017-11-09 | Medivir | Results MIV-711 phase IIa osteoarthritis study data presented as a late breaking poster at the Annual Meeting of the American College for Rheumatology medivir.com ↗
Treatment with MIV-711 resulted in substantial joint protective effects after 6 months of treatment, reducing both joint bone area growth and cartilage loss compared to placebo. |
| 2017-10-24 | Medivir | Regulatory Medivir receives FDA Fast Track Designation for MIV-711 for the treatment of OA medivir.com ↗
Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR ) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company´s product candidate MIV-711, for the treatment of osteoarthritis (OA). |
| 2017-10-20 | Medivir | Results MIV-711 phase IIa osteoarthritis study data selected as late breaking abstract at the Annual Meeting of the American College for Rheumatology medivir.com ↗
Furthermore, treatment with MIV-711 reduced the loss of medial femur cartilage thickness versus placebo (unadjusted p=0.023 for 100mg dose, 0.125 for 200mg dose). |
| 2017-09-25 | Medivir | Results Medivir announces positive topline results from phase IIa osteoarthritis study, showing disease-modifying benefit of MIV-711 on joint structure medivir.com ↗
Medivir AB (Nasdaq Stockholm: MVIR) today announces positive top line data from MIV-711-201, the 6-month initial phase IIa study of MIV-711 in patients with moderate knee osteoarthritis. |
| 2017-09-14 | Medivir | Results Data monitoring committee gives “Go Ahead” in the MIV-711 osteoarthritis extension study medivir.com ↗
Medivir AB (Nasdaq Stockholm: MVIR) today announces that the independent Data Monitoring Committee (DMC) has again recommended continuation of the MIV-711 osteoarthritis extension study without modifications based on a review of the accumulated safety data. |
| 2017-08-16 | Medivir | Regulatory FDA accepts Medivir´s IND application for MIV-711, enabling clinical development in the US medivir.com ↗
Medivir AB (Nasdaq Stockholm: MVIR ) announces today that the Investigational New Drug (IND) application for MIV-711 has been accepted and the IND is now open with the FDA (U.S. Food and Drug Administration). |
| 2017-02-01 | Medivir | Results MIV-711 Osteoarthritis Trial: Successful fourth independent review of safety data enables trial continuation without any modifications medivir.com ↗ |
| 2016-12-08 | Medivir | Results MIV-711 Osteoarthritis Trial: Successful third independent review of safety data and trial continues without any modifications medivir.com ↗
Based on the review of the accumulated safety data after the first 150 subjects had completed 3 months of treatment, the DMC has recommended that the phase IIa trial of osteoarthritis should continue without any modifications. |
| 2016-09-23 | Medivir | Results MIV-711 Osteoarthritis Trial: Recommendation to Go Ahead based on independent review of safety data, and first patient enrolled in extension study medivir.com ↗
The independent Data Monitoring Committee (DMC) has recommended continuation of the ongoing randomized, double-blind phase IIa study (MIV-711-201) based on a review of unblinded safety data. |
| 2013-10-09 | Medivir | Results Positive results from a phase I study with MIV-711 for the treatment of osteoarthritis and other bone related disorders medivir.com ↗
Medivir AB (OMX:MVIR) announced further results from the phase I clinical study on the investigational cathepsin K inhibitor MIV-711 for the treatment of osteoarthritis and other bone related disorders. |
| 2013-05-21 | Medivir | Results Positive results from a phase Ia study with MIV-711 for the treatment of skeletal disorders medivir.com ↗
Single doses of MIV-711 were safe and well tolerated in healthy subjects and displayed linear pharmacokinetics over the investigated dose range (20 – 600 mg) |
| 2009-09-16 | Medivir | Results Medivir presented its cathepsin K program at the ongoing 31st ASBMR meeting in Denver, USA medivir.com ↗
These inhibitors when dosed to cynomolgus monkey are well-tolerated and inhibit circulating CTX-I levels (marker of bone resorption) by up to 95%. |
All press releases naming this drug 28 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MIV-711 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03037489 ↗ |
| Known as | MV076159 | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068585 ↗ |
| Route | Oral | “administered orally once daily” NCT02705625 ↗ |