fluorouracil cream 0.5%

ApprovedCompleted

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Interest: 43/100

Hype Score

Development Stage

✓

Pre-clinical

✓

Phase 1

✓

Phase 2

✓

Phase 3

Approved

Indication / Disease

Actinic Keratoses

Conditions

Actinic Keratoses

Trial Timeline

Nov 1, 2003 → Oct 1, 2005

NCT ID

NCT00377273

About fluorouracil cream 0.5%

fluorouracil cream 0.5% is a approved stage product being developed by Sanofi for Actinic Keratoses. The current trial status is completed. This product is registered under clinical trial identifier NCT00377273. Target conditions include Actinic Keratoses.

What happened to similar drugs?

6 of 20 similar drugs in Actinic Keratoses were approved

Approved (6) Terminated (1) Active (14)

✅Imiquimod + DiclofenacViatrisApproved

✅Tirbanibulin (Klisyri®) 10 mg/g ointment + Diclofenac Sodium 3% GelAlmirallApproved

✅Tirbanibulin 2.5 mg ointmentAlmirallApproved

✅TirbanibulinAlmirallApproved

✅Ameluz 10% Topical GelBiofronteraApproved

🔄Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%Sun PharmaceuticalPhase 3

Hype Score Breakdown

Clinical

Activity

Company

Novelty

Community

Clinical Trials (1)

NCT ID	Phase	Status	Start	Completion	Indication
NCT00377273	Approved	Completed	Nov 1, 2003	Oct 1, 2005	Actinic Keratoses

Competing Products

20 competing products in Actinic Keratoses

See all competitors

Product	Company	Stage	Hype Score
Low dose DFD07 once daily + High dose DFD07 once daily + High dose DFD07 twice daily + Placebo twice daily	Dr. Reddy's Laboratories	Phase 2/3	35
Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%	Sun Pharmaceutical	Phase 3	44
Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%	Sun Pharmaceutical	Phase 3	44
Diclofenac Sodium Gel 3% + Solaraze® (diclofenac sodium) Gel 3% + Vehicle Topical Gel	Sun Pharmaceutical	Phase 1	29
Imiquimod Topical Cream 3.75% + Zyclara® (imiquimod) Topical Cream 3.75% + Vehicle Topical Cream	Sun Pharmaceutical	Phase 1	29
Imiquimod 5% manufactured by Taro + Aldara - Imiquimod 5% + Imiquimod Vehicle manufactured by Taro	Sun Pharmaceutical	Phase 1	29
Investigational Treatment + Active comparator	Novartis	Phase 2	35
KX01 ointment 1% + Placebo	PharmaEssentia	Phase 3	40
Fluorouracil	Sanofi	Phase 1/2	32
Imiquimod + Diclofenac	Viatris	Approved	40
Imiquimod 5 % Cream	Viatris	Phase 2	32
Imiquimod	Viatris	Pre-clinical	23
Aldara (Imiquimod)	Viatris	Phase 3	37
Imiquimod + Diclofenac	Viatris	Approved	40
Placebo Gel + LAS41005 + LAS106521	Almirall	Phase 3	34
5-fluorouracil/salicylic acid + Vehicle	Almirall	Phase 3	34
50 mg of KX2-391 Ointment 1% + 50 mg of KX2-391 Ointment 1%	Almirall	Phase 2	29
Tirbanibulin (Klisyri®) 10 mg/g ointment + Diclofenac Sodium 3% Gel	Almirall	Approved	41
KX2-391 Ointment 1% + Placebo	Almirall	Phase 3	34
Tirbanibulin 2.5 mg ointment	Almirall	Approved	37