Data updated: Nov 8, 2026
FRAGMIN (dalteparin sodium) · Pfizer
Trial Activity: Stable 1 active trials
Cardiovascular
Approved 1994-12-22
Development Insights
Pfizer conducting 2 trials (50%)
5 indications explored (Moderate)
→ venous thromboembolism (2 trials)
→ varicose veins (1 trials)
→ postpartum (1 trials)
8
Indications
--
Phase 3 Trials
1
Priority Reviews
31
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1994-12-22
- Revenue
- $63M (Q4-2023)
- Routes
- INJECTION, SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
FRAGMIN Approval History
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
564 FDA actions from 1994 to 2024 · 6 indication expansions
Sep 2019 SUPPL
Label
Jan 2017 SUPPL
Mfg
Oct 2013 SUPPL
Mfg
Sep 2013 SUPPL
Mfg
Sep 2002 SUPPL
Mfg
Apr 2002 SUPPL
Mfg
Mar 2002 SUPPL
Mfg
Sep 2001 SUPPL
Mfg
Jun 2001 SUPPL
Mfg
Nov 2000 SUPPL
Mfg
Aug 1999 SUPPL
Mfg
Jun 1999 SUPPL
Mfg
Jan 1999 SUPPL
Mfg
Jan 1998 SUPPL
Mfg
Apr 1997 SUPPL
Mfg
Jan 1997 SUPPL
Mfg
Sep 1996 SUPPL
Label
Mar 1996 SUPPL
Mfg
Aug 1995 SUPPL
Label
Dec 1994 ORIGINAL
New Drug
What FRAGMIN Treats
8 FDA approvalsOriginally approved for its first indication in 1994 . Covers 8 distinct patient populations.
- Other (8)
Other
(8 approvals)- • Approved indication (Dec 1994)
- • Approved indication (Mar 1996)
- • Approved indication (Mar 1999)Label Letter
- • Approved indication (May 1999)Label Letter
- • Approved indication (Dec 2003)Label Letter
- • Approved indication (May 2007)Label Letter
- • Approved indication (May 2019) PriorityLabel Letter
- • Approved indication (Oct 2024)Label Letter
Pfizer's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
HYMPAVZI
2024 MARSTACIMAB-HNCQ
2 designations
ZAVZPRET
2023 ZAVEGEPANT HYDROCHLORIDE
NGENLA
2023 SOMATROGON-GHLA
1 designation
VELSIPITY
2023 ETRASIMOD ARGININE
PAXLOVID (COPACKAGED)
2023 NIRMATRELVIR
3 designations
LITFULO
2023 RITLECITINIB TOSYLATE
ELREXFIO
2023 ELRANATAMAB
5 designations
CIBINQO
2022 ABROCITINIB
2 designations
NURTEC ODT
2020 RIMEGEPANT SULFATE
VIZIMPRO
2018 DACOMITINIB
2 designations
DAURISMO
2018 GLASDEGIB MALEATE
2 designations
TALZENNA
2018 TALAZOPARIB TOSYLATE
1 designation
📋
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05735639 THRIVE | 22CX7510 ISRCTN18501431 | Ph 4 | recruiting | THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE) |
| NCT01274637 PROSPER results posted | 2010303-01H | Ph 3 | completed | PROSPER: PostpaRtum PrOphylaxiS for PE Randomized Control Trial Pilot |
| NCT01879618 results posted | A6301091 | Ph 3 | completed | Use Of Fragmin In Hemodialysis |
| NCT00765063 results posted | A6301086 | Ph 2, Ph 3 | completed | The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086) |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FRAGMIN FDA Label Details
Pro Intelligence Preview
Deep insights for FRAGMIN
Revenue Insights
- • Q4-2023: $63M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • 4 total trials
- • Stage: Stable
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment