drug
sirolimus albumin-bound
Marketedupdated 5mo agoby Kaken Pharmaceutical Co Ltd
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 3Small molecule drug with a maximum clinical stage of Approval (across all indications), with 19 approved and 113 investigational indications.
all catalysts(0)
nothing on the calendar yet
Trials studying sirolimus albumin-bound
- phase2A Phase 1/2 Study of Intravenous Gene Transfer With an AAV9 Vector Expressing Human Beta-galactosidase in Type I and Type II GM1 Gangliosidosis
- phase2Phase 1/2a Clinical Trial of PR001 (LY3884961) in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL)
- N/AIVUS-Guided Sirolimus-Coated Balloon Versus Sirolimus-Eluting Stent for De Novo Large Vessel Lesions in ACS
- phase2Study of ASP2957 in Male Participants With X-linked Myotubular Myopathy Who Need Ventilators
- N/AHybrid Sirolimus-eluting Versus Everolimus-eluting Stents for Total Coronary Occlusions
- phase2A Phase 1/2 Study of UB-VV400 With Rapamycin in Relapsed/Refractory B-cell Malignancies
- phase1A Phase 1 Study of UB-VV500 With Rapamycin in Relapsed/Refractory Multiple Myeloma
- N/AMOTIV BTK Randomized Controlled Trial
Patent cliff
source: FDA Orange Bookfirst barrier falls
Nov 22, 2028
~2.1 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (7)
- Oct 28, 2040formulationUS 11497737
- Jun 29, 2036method-of-use (U-3258)US 10973806
- Jun 29, 2036method-of-use (U-4042)US 12133844
- Mar 5, 2036formulationUS 10705070
- Mar 5, 2036formulationUS 12061183
- Apr 15, 2030formulationUS 102068873.5y
- Feb 14, 2029formulationUS 89117862.4y
FDA exclusivities (2)
- Mar 22, 2029ODE-391Orphan Drug (7y)2.5y
- Nov 22, 2028ODE-386Orphan Drug (7y)2.1y
News(4)
- Cordis’ sirolimus drug-coated balloon earns FDA approval as a breakthrough deviceThe FDA gave the green light to a first and only sirolimus drug-eluting balloon designed by Cordis to treat coronary in-stent restenosis.fiercebiotech · 9d ago
- Opinion: Limb girdle muscular dystrophy patients face a maddening reality“Too often, regulatory tools authorized to speed patient access to breakthrough treatments are being used in ways that even prevent approval,” writes Kat Bryant Knudson.stat · 2mo ago
- Ipsen’s $450M blood cancer drug; FDA selects first cohort for “pre-check” pilot programThe planned acquisition of Kartos Therapeutics would hand Ipsen a late-stage asset for myelofibrosis. Elsewhere, Sobi hit a regulatory setback and BeOne unveiled more positive Brukinsa data.biopharma_dive · 3mo ago
- STAT+: Drug meant to make gene therapy safer may also make it less effectiveEncoded Therapeutics gives a heads-up to other gene therapy company about the trade-offs with a drug meant to improve safety.stat · 4mo ago
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