drugset
Drugs / CL-108
last change Aug 2017 re-read 2 minutes ago

CL-108

Investigated by
Charleston Laboratories, Inc

Trials 2 · a red edge is where a trial was stopped

today NCT02712554 · Ph 1 NCT02465866 · Ph 1
2015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT02712554 Jun → Sep 2015 — Charleston Laboratories, Inc Completed No outcome recorded
Phase 1 NCT02465866 Nov 2014 → Apr 2015 — Charleston Laboratories, Inc Completed No outcome recorded

Press releases naming this drug 4 releases

DateIssuerRelease
2017-08-31 Daiichi Sankyo Daiichi Sankyo Terminates Development and Commercialization Agreement with Charleston Laboratories Regarding Hydrocodone Products in the U.S., including CL-108 daiichisankyo.com ↗
2017-02-06 Daiichi Sankyo Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Receive Complete Response Letter from FDA for New Drug Application for CL-108 (hydrocodone, acetaminophen, promethazine) Tablets for Oral Use daiichisankyo.com ↗
2016-06-14 Daiichi Sankyo Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Announce FDA Acceptance of New Drug Application (NDA) for CL-108 daiichisankyo.com ↗
2015-10-30 Daiichi Sankyo Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Announce Phase 3 Study of CL-108 Met Primary Endpoints daiichisankyo.com ↗

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as CL-108 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02712554 ↗
1

NCT02465866 ↗
Route Oral “single dose by mouth” NCT02465866 ↗