pharmadog
News
when
  • Latest
  • Archive
by source
  • All Sources
  • Sources Page
Jobs
department
  • Clinical
  • Regulatory
  • Medical Affairs
  • Commercial
  • R&D / Discovery
  • Biostatistics / Data
  • Manufacturing / CMC
  • Market Access
therapeutic area
  • Oncology
  • Immunology
  • Neuroscience
  • Cardiovascular
  • Metabolic
  • Rare Disease
  • Infectious Disease
location & type
  • Remote Only
  • US Only
  • California
  • Massachusetts
  • Internships
  • Phase 3 Roles
  • All Jobs →
Sign InSubscribe
pharmadog

fetch the data · sniff the signal

Discover
  • Jobs
  • News
Hubs
  • Topics
  • Patent cliff
  • Publications
Tools
  • Compare
  • Search
  • Bookmarks
Trust
  • About
  • Sources
  • Contact
Legal
  • Privacy
  • Terms
  • Pricing

© 2026 pharmadog.xyz

made by humans and a good dog

  • home
  • jobs
  • news
  • search
  1. pharmadog
  2. ›drugs
  3. ›Koselugo
drug
save

selumetinib sulfate

Marketedupdated 3mo ago
by AstraZeneca Pharmaceuticals LP
Approved
community read0 votes

🐶 often sniffed alongside

top 3
  • drugKOSELUGO24 co-mentions · 7 sources
  • tagApproval24 co-mentions · 7 sources
  • tagSmall Molecule12 co-mentions · 7 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for neurofibromatosis type 1 and neoplasm and 20 investigational indications.

all catalysts(7)

approval · 7
Apr 10, 2020
approval
$AZN161.91+0.30%
6y ago
KOSELUGO (SELUMETINIB SULFATE) — FDA approval
selumetinib sulfate
→
Dec 22, 2021
approval
$AZN161.91+0.30%
5y ago
KOSELUGO (SELUMETINIB SULFATE) — FDA approval
selumetinib sulfate
→
Jan 24, 2024
approval
$AZN161.91+0.30%
3y ago
KOSELUGO (SELUMETINIB SULFATE) — FDA approval
selumetinib sulfate
→
Sep 10, 2025
approval
$AZN161.91+0.30%
11mo ago
KOSELUGO (SELUMETINIB SULFATE) — FDA approval
selumetinib sulfate
→
Sep 10, 2025
approval
$AZN161.91+0.30%
11mo ago
KOSELUGO (SELUMETINIB) — FDA approval
selumetinib sulfate
→
Nov 19, 2025
approval
$AZN161.91+0.30%
9mo ago
KOSELUGO (SELUMETINIB SULFATE) — FDA approval
selumetinib sulfate
→
Nov 19, 2025
approval
$AZN161.91+0.30%
9mo ago
KOSELUGO (SELUMETINIB) — FDA approval
selumetinib sulfate
→

Patent cliff

source: FDA Orange Book
first barrier falls
Dec 12, 2026
123 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (24)

  • Mar 26, 2029formulationUS 118132462.6y
  • Mar 26, 2029formulationUS 118132462.6y
  • Mar 26, 2029formulationUS 122204032.6y
  • Mar 26, 2029formulationUS 122204032.6y
  • Mar 26, 2029formulationUS 123183672.6y
  • Mar 26, 2029formulationUS 123183672.6y
  • Mar 26, 2029method-of-use (U-4357)US 123646842.6y
  • Mar 26, 2029method-of-use (U-4357)US 123646842.6y
  • Mar 13, 2028compositionUS 74256371.6y
  • Mar 13, 2028compositionUS 74256371.6y
  • Mar 13, 2028compositionUS 74256371.6y
  • Mar 13, 2028compositionUS 74256371.6y
  • Dec 12, 2026compositionUS 9156795123d
  • Dec 12, 2026compositionUS 9156795123d
  • Dec 12, 2026compositionUS 9156795123d
  • Dec 12, 2026compositionUS 9156795123d
  • Dec 12, 2026compositionUS 9562017123d
  • Dec 12, 2026compositionUS 9562017123d
  • Dec 12, 2026compositionUS 9562017123d
  • Dec 12, 2026compositionUS 9562017123d
  • Mar 13, 2026compositionUS 8178693
  • Mar 13, 2026compositionUS 8178693
  • Mar 13, 2026compositionUS 8178693
  • Mar 13, 2026compositionUS 8178693

FDA exclusivities (12)

  • Nov 19, 2028NPPNew Product (3y)2.3y
  • Nov 19, 2028NPPNew Product (3y)2.3y
  • Nov 19, 2028NPPNew Product (3y)2.3y
  • Nov 19, 2028NPPNew Product (3y)2.3y
  • Sep 10, 2028NPPNew Product (3y)2.1y
  • Sep 10, 2028NPPNew Product (3y)2.1y
  • Sep 10, 2028NPNP2.1y
  • Sep 10, 2028NPNP2.1y
  • Apr 10, 2027ODE*ODE*242d
  • Apr 10, 2027ODE*ODE*242d
  • Apr 10, 2027ODE-288Orphan Drug (7y)242d
  • Apr 10, 2027ODE-288Orphan Drug (7y)242d

News(0)

no news has mentioned this drug yet

brand
Koselugo
generic
selumetinib sulfate
MOA
12.1 Mechanism of Action Selumetinib is an inhibitor of mitogen-activated protein kinase kinases 1 and 2 (MEK1/2). MEK1/2 proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway. Both MEK and ERK are critical components of the RAS-regulated RAF-MEK-ERK pathway, which is often activated in different types of cancers. In genetically modified mouse models of NF1 that generate neurofibromas that recapitulate the genotype and phenotype of human NF1, oral dosing of selumetinib inhibited ERK phosphorylation, and reduced neurofibroma numbers, volume, and proliferation.
indication
Plexiform Neurofibroma
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 1h ago
Found something off?
🐶 something off?

Report a data issue

Tell Bork what looks wrong — wrong sponsor, stale phase, mislinked ticker, anything. We’ll triage and fix.

comments(0)

5-min edit window · permanent after that
sign in to leave a comment · permanent archive after 5 minutes
no comments yet — first sniff?