drug
sirolimus albumin-bound
Marketedupdated 3mo 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 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
- phase1131I-apamistamab-based Conditioning for Hematopoietic Stem Cell Transplant (HSCT) in Advanced Sickle Cell Disease (SCD)
- N/ASafety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
- phase2TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer
- phase3Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors
- —S-FLEX Netherlands Registry: Prospective Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System
Patent cliff
source: FDA Orange Bookfirst barrier falls
Nov 22, 2028
~2.3 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 102068873.7y
- Feb 14, 2029formulationUS 89117862.5y
FDA exclusivities (2)
- Mar 22, 2029ODE-391Orphan Drug (7y)2.6y
- Nov 22, 2028ODE-386Orphan Drug (7y)2.3y
News(3)
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- 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 · 1mo 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 · 3mo ago
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