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Helsinn

For profitContributed to NMEWebsite ↗

Also known as: HELSINN | Helsinn Healthcare SA | HELSINN HLTHCARE | Helsinn Therapeutics (U.S.), Inc

Phase 1Phase 2Phase 3Phase 4

Highest phase reached

Phase 4

First clinical trial

Sep 1, 2004

First marketed drug

Jul 25, 2003

First NDA

Jul 25, 2003

Last known activity

Sep 9, 2023

Timeline

1970s

  1. Jan 1, 1976

    Helsinn— Founded

1990s

  1. Jan 1, 1990

    Birex Pharmaceuticals— Acquired

2000s

  1. Jul 25, 2003

    palonosetron— NDA Organization

  2. Jan 1, 2009

    Sapphire Therapeutics— Acquired

2010s

  1. Aug 23, 2013

    mechlorethamine— NDA Secondary Org

2020s

  1. May 28, 2021

    infigratinib— Marketing Organization

Drugs by trial phase (32 distinct, 49 trials)

Phase 1 (4 own, 0 via acquisition)

Other trials (6 own, 0 via acquisition)

Indications

Approved for

Studied for

Marketed drugs (5)

Subsidiaries (2 direct, 2 total across the full acquisition tree)

Recent trials (50)

Details

Founded
Tessin, CH Jan 1, 1976
First NDA
Jul 25, 2003
Last known activity
Sep 9, 2023

Designations held

  • Orphan drug
  • Fast track
  • Priority review
  • Accelerated approval