Drugs / Delavirdine

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) RESCRIPTOR 2001-05-16 fda.gov
Approved US (FDA) RESCRIPTOR 1997-04-04 fda.gov

Trials 19 · a red edge is where a trial was stopped

19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT00000810 ? → Jan 1996 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 26 trials
Phase 2 NCT00002210 HIV infectious disease Pharmacia and Upjohn Completed No outcome recorded
Phase 2 NCT00002420 HIV infectious disease Bristol-Myers Squibb Terminated No outcome recorded
Phase 2 NCT00000891 ? → May 2004 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT00000882 ? → May 1999 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT00001094 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Withdrawn No outcome recorded
Phase 2 NCT00000803 ? → Mar 1997 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT00624195 Mar 2007 → Feb 2012 HIV infectious disease University of California, San Diego Completed No outcome recorded
Phase 34 trials
Phase 3 NCT00002124 HIV infectious disease Pharmacia and Upjohn Completed No outcome recorded
Phase 3 NCT00002378 HIV infectious disease Hoffmann-La Roche Completed No outcome recorded
Phase 3 NCT00002178 HIV infectious disease Hoffmann-La Roche Completed No outcome recorded
Phase 3 NCT00002123 HIV infectious disease Pharmacia and Upjohn Completed No outcome recorded
Phase not applicable7 trials
NCT00006326 Aug 2000 → ? HIV infectious disease Agouron Pharmaceuticals Terminated No outcome recorded
NCT00000892 ? → Aug 1999 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
NCT00002211 HIV infectious disease Pharmacia and Upjohn Completed No outcome recorded
NCT00002400 HIV infectious disease Pharmacia and Upjohn Completed No outcome recorded
NCT00002312 HIV infectious disease Pharmacia and Upjohn Completed No outcome recorded
NCT00002236 HIV infectious disease Pharmacia and Upjohn Completed No outcome recorded
NCT00002401 HIV infectious disease Pharmacia and Upjohn Completed No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT02249130 Background Mar 1999 → Apr 2000 HIV infectious disease Boehringer Ingelheim Completed No outcome recorded
Phase 31 trial
Phase 3 NCT03631732 Comparator Aug 2018 → Aug 2019 HIV infectious disease Gilead Sciences Completed No outcome recorded

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 22 sources stand behind the page.

FieldValueCited text
Known as Delavirdine “Generic names: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine,...” NCT00624195
19

delavirdine (DLV)” NCT03631732

NCT00006326

NCT00002210

NCT00002312

NCT00002178

NCT00002123

NCT00001094

NCT00000803

NCT00000882

NCT00002236

NCT00002420

NCT00002401

NCT00002400

NCT00000810

NCT00000891

NCT00000892

NCT02249130

NCT00002124

NCT00002211

Known as Delavirdina ChEMBL registry synonym — accepted as the source's own label CHEMBL593
Known as Delavirdine mesilate ChEMBL registry synonym — accepted as the source's own label CHEMBL593
Known as Delavirdine mesylate “The purpose of this study is to see if it is safe and effective to give delavirdine mesylate (Rescriptor) plus two nucleoside reverse transcriptase inhibitors (NRTIs) to...” NCT00002210
3

“Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)” NCT00000810

Delavirdine mesylate ( U-90152 )” NCT00000803

NCT00002378

Known as Delavirdine methanesulfonate ChEMBL registry synonym — accepted as the source's own label CHEMBL593
Known as DLV “An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) Plus Nelfinavir (NFV), Didanosine (ddI), and Stavudine (d4T) in Triple and Quadruple Treatment Regimens...” NCT00002211
11

“Zidovudine (ZDV), lamivudine (3TC), stavudine (d4T), didanosine (ddI), delavirdine (DLV), ritonavir (RTV), and saquinavir soft gel capsules (SQV sgc) are provided on-study.” NCT00000891

“The purpose of this study is to see if it is safe and effective to give delavirdine (DLV) in combination with two or three other drugs to HIV-infected patients.” NCT00002401

“Arm A: Saquinavir (SQV) plus ritonavir (RTV) plus delavirdine (DLV) plus adefovir dipivoxil placebo.” NCT00000892

“delavirdine (DLV) plus indinavir (IDV) plus zidovudine (ZDV)” NCT00002236

“Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)” NCT00000810

“delavirdine mesylate (DLV)” NCT00002124

“delavirdine (DLV)” NCT03631732

“delavirdine (DLV)” NCT00002420

“Delavirdine (DLV)” NCT02249130

“Delavirdine (DLV)” NCT00000882

“delavirdine (DLV)” NCT00001094

Known as Rescriptor “An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) Plus Nelfinavir (NFV), Didanosine (ddI), and Stavudine (d4T) in Triple and Quadruple Treatment Regimens...” NCT00002211
3

“The purpose of this study is to see if it is safe and effective to give delavirdine mesylate (Rescriptor) plus two nucleoside reverse transcriptase inhibitors (NRTIs) to...” NCT00002210

“An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) in Triple and Quadruple Combinations With Zidovudine (ZDV), Indinavir (IDV), and Lamivudine (3TC) in...” NCT00002401

Rescriptor (Delavirdine Mesylate)” NCT00002420

Known as U-90152 “To evaluate the pharmacokinetics, safety, and tolerance of delavirdine mesylate ( U-90152 ) after multiple doses given orally to asymptomatic HIV-1 positive patients who are...” NCT00002312
2

“delavirdine mesylate ( U-90152 ) monotherapy” NCT00000810

“Delavirdine mesylate ( U-90152 )” NCT00000803

Known as U-90152S “Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)” NCT00000810
2

“Delavirdine Mesylate (U-90152S)” NCT00002124

“Delavirdine Mesylate (U-90152S)” NCT00002123

Known as U-90152T ChEMBL registry synonym — accepted as the source's own label CHEMBL593
Action Inhibit “nonnucleoside reverse transcriptase inhibitor (NNRTI) DLV” NCT00000882
Modality Small molecule “bisheteroarylpiperazines (BHAPs) such as delavirdine mesylate are potent and safe anti-HIV agents” NCT00000810
Route Oral “multiple doses given orally” NCT00002312