Drugs / Nabiximols
Nabiximols
also known as
Sativex · GW-1000-02 · Cannabis Based Medicine Extract · Cannabis sativa L., folium cum flore · GW 1000 · Nabidiolex · SAB378 · Tetranabinex
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | Sativex | spastic paraplegia with myoclonic epilepsy | 2012-02-07 | “Almirall S.A. (ALM.MC) today announced the start of a second wave of regulatory submissions for Sativex ® in Europe.” almirall.com ↗ |
| Filed | EU (EMA) | Sativex | spastic paraplegia with myoclonic epilepsy | 2010-07-28 | “GW Pharmaceuticals has submitted an application under the European Mutual Recognition Procedure (MRP) to seek marketing authorization for Sativex® in other selected European...” almirall.com ↗ |
Trials 49
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials · 1 missed | ||||||
| Phase 1 | NCT05503147 | Mar 2022 → Aug 2023 | eating disorder, impaired renal function disease, nutritional deficiency disease | Ove Andersen | Unknown | Missed primary |
| Phase 1 | NCT02325024 | Jan → Oct 2016 | impaired renal function disease | GW Pharmaceuticals Ltd | Withdrawn | No outcome recorded |
| Phase 1 | NCT02432612 | Oct 2015 → Oct 2016 | cancer of unknown primary site | GW Pharmaceuticals Ltd | Withdrawn | No outcome recorded |
| Phase 1 | NCT02325011 | Nov 2014 → Feb 2015 | — | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01975688 | Feb 2014 → Mar 2015 | head and neck squamous cell carcinoma | GW Pharmaceuticals Ltd | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01887301 | Jul 2013 → May 2014 | — | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01323465 | Feb → Mar 2008 | — | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01323569 | Feb → Jun 2008 | — | Jazz Pharmaceuticals | Completed | Mixed |
| Phase 1 | NCT01322464 | Jan → Feb 2008 | — | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01037608 | May 2007 → Aug 2011 | cannabis dependence, substance abuse | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT01812616 | Sep 2014 → Jun 2016 | cancer | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT01812603 | Sep 2013 → Jan 2015 | cancer | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 26 trials · 1 missed | ||||||
| Phase 2 | NCT05974293 | Dec 2026 → Apr 2027 | neuromyelitis optica | Michael, Levy M.D.,Ph.D. | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT05629702 | Feb 2023 → Sep 2026 overdue | brain neoplasm, glioblastoma | University of Birmingham | Recruiting | No outcome recorded |
| Phase 2 | NCT01747850 | Mar 2013 → Nov 2015 | cannabis dependence | Centre for Addiction and Mental Health | Completed | No outcome recorded |
| Phase 2 | NCT00723918 | Apr 2009 → Jan 2010 | polyneuropathy | Washington University School of Medicine | Withdrawn | No outcome recorded |
| Phase 2 | NCT00530764 | Nov 2007 → Jan 2010 | cancer | GW Pharmaceuticals Ltd | Completed | Missed primary |
| Phase 2 | NCT00202423 | Jul 2005 → ? | multiple sclerosis | S. Andrea Hospital | Unknown | No outcome recorded |
| Phase 2/32 trials · 1 met primary | ||||||
| Phase 2/3 | NCT04592159 | Feb 2021 → Mar 2023 | post-traumatic stress disorder | Jazz Pharmaceuticals | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT01776970 | Jan 2013 → Dec 2015 | amyotrophic lateral sclerosis | Ospedale San Raffaele | Completed | Met primary |
| Phase 327 trials · 6 met primary · 13 missed | ||||||
| Phase 3 | NCT04984278 | Aug 2021 → Nov 2022 | multiple sclerosis | Jazz Pharmaceuticals | Terminated | Met primary Stop: Business |
| Phase 3 | NCT04657666 | Dec 2020 → May 2022 | — | Jazz Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT04203498 | Oct 2020 → Feb 2023 | multiple sclerosis | Jazz Pharmaceuticals | Terminated | Missed primary Stop: Business |
| Phase 3 | NCT03087201 | Apr 2018 → Nov 2020 | Tourette syndrome | Hannover Medical School | Completed | No outcome recorded |
| Phase 3 | NCT01424566 | Jun 2012 → Jul 2015 | — | Jazz Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT01538225 | Apr 2012 → Nov 2013 | multiple sclerosis | Almirall, S.A. | Completed | No outcome recorded |
| Phase 3 | NCT01361607 | May 2011 → Nov 2014 | — | Jazz Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT01337089 | Jan 2011 → Jan 2016 | — | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01262651 | Nov 2010 → Jul 2015 | — | GW Pharmaceuticals Ltd | Completed | Missed primary |
| Phase 3 | NCT00681538 | Jan 2008 → Jan 2009 | multiple sclerosis | Jazz Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00702468 | Nov 2007 → Jan 2009 | multiple sclerosis | Jazz Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00713817 | Mar → Jul 2007 | peripheral neuropathy | Jazz Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT00391079 | Sep 2006 → Apr 2008 | multiple sclerosis | GW Pharmaceuticals Ltd | Completed | Missed primary |
| Phase 3 | NCT00710554 | Aug 2005 → Oct 2006 | peripheral neuropathy | Jazz Pharmaceuticals | Completed | Mixed |
| Phase 3 | NCT00710424 | Jul 2005 → Jun 2006 | diabetic neuropathy | Jazz Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT01599234 | Mar → Dec 2005 | multiple sclerosis | Jazz Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT00678795 | Aug 2002 → Oct 2005 | multiple sclerosis, urinary bladder disorder | Jazz Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT01606202 | Jul 2002 → Jan 2005 | — | Jazz Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT00711646 | Jun 2002 → Mar 2004 | multiple sclerosis | Jazz Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00711880 | May 2002 → Mar 2004 | peripheral neuropathy | Jazz Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00675948 | Apr 2002 → Sep 2006 | cancer | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01604265 | Mar → Aug 2002 | multiple sclerosis, neuropathy, painful | Jazz Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01606176 | Mar → Aug 2002 | multiple sclerosis | Jazz Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT00674609 | Feb 2002 → Feb 2004 | cancer | Jazz Pharmaceuticals | Completed | Mixed |
| Phase 3 | NCT01606189 | Dec 2001 → Sep 2002 | — | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01610700 | May 2001 → Jul 2002 | multiple sclerosis | Jazz Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT01868048 | ? → Jun 2017 | multiple sclerosis | GW Research Ltd | Withdrawn | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT03186664 | Dec 2016 → Dec 2017 | — | IRCCS Centro Neurolesi Bonino Pulejo | Completed | No outcome recorded |
| — | NCT01748799 | Feb 2013 → Sep 2014 | cannabis dependence | Centre for Addiction and Mental Health | Completed | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 1 | NCT03201835 Comparator | Sep → Dec 2015 | — | PhytoTech Therapeutics, Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01322139 Comparator | Dec 2007 → Jun 2008 | — | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01898520 Comparator | Dec 2013 → Sep 2016 | cerebral palsy | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00872144 Comparator | Jun 2010 → Dec 2012 | neuropathy, painful | Mary Lynch | Completed | No outcome recorded |
| Phase 4 | NCT01964547 Comparator | Jan 2012 → May 2013 | multiple sclerosis | Jazz Pharmaceuticals | Completed | No outcome recorded |
| — | NCT04820361 Comparator | Jul 2022 → Dec 2023 | neuropathy, painful | Albina Nowak, MD | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2022-06-28 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals Announces Top-line Results from Phase 3 Trial Evaluating Nabiximols Oromucosal Spray in Adult Participants with Multiple Sclerosis Spasticity jazzpharma.com ↗
The RELEASE MSS1 trial did not meet the primary endpoint of change in Lower Limb Muscle Tone-6 (LLMT-6) between baseline and Day 21, as measured by the Modified Ashworth Scale (MAS). |
| 2017-10-27 | Almirall, S.A. | Results New randomized controlled study confirms the efficacy and tolerability profile of Sativex® in the treatment of multiple sclerosis spasticity resistant patients almirall.com ↗
The results of this study demonstrate that Sativex ® is an effective and well-tolerated add-on option for treating patients with resistant multiple sclerosis spasticity, as well as burdensome associated symptoms instead of just adjusting again the first line options treatment. |
| 2013-10-02 | Almirall, S.A. | Results New data reinforce the efficacy and safety profile of Sativex® in Multiple Sclerosis Spasticity almirall.com ↗
These data, presented today at the 29 th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark, show that Sativex®effectiveness is maintained long term with no additional safety concerns identified in clinical practice. |
| 2012-10-15 | Almirall, S.A. | Results Sativex® confirms clinically relevant benefits in Multiple Sclerosis Spasticity almirall.com ↗
The new study data shows that, after three months, 41% of patients treated with Sativex®, who were resistant to other therapies, showed a clinically relevant effect |
| 2012-05-08 | Almirall, S.A. | Regulatory Sativex® Mutual Recognition Procedure Closes with Recommendation for Approval in Ten European Countries almirall.com ↗
The MRP has now closed successfully with regulatory authorities in all ten countries confirming that Sativex ® meets their requirements for approval. |
| 2012-02-07 | Almirall, S.A. | Regulatory Sativex® starts a new wave of regulatory submissions in Europe almirall.com ↗
Almirall S.A. (ALM.MC) today announced the start of a second wave of regulatory submissions for Sativex ® in Europe. |
| 2011-10-24 | Almirall, S.A. | Results Full Phase III data highlight the efficacy and tolerability of Sativex® as therapy for the treatment of spasticity in MS almirall.com ↗ |
| 2011-06-08 | Almirall, S.A. | Regulatory Sativex® approved in Denmark for the treatment of spasticity due to Multiple Sclerosis (MS) almirall.com ↗
The Danish Interior and Health Minister approves Sativex ® , the first cannabis-based medicine in Denmark |
| 2011-04-28 | Almirall, S.A. | Regulatory Sativex® approved in Germany for the treatment of spasticity due to Multiple Sclerosis almirall.com ↗ |
| 2010-10-14 | Almirall, S.A. | Results Sativex® data presented at ECTRIMS congress highlights its efficacy as an add on therapy for the treatment of spasticity in people with multiple sclerosis almirall.com ↗ |
| 2010-07-28 | Almirall, S.A. | Regulatory Sativex® receives regulatory authorisation in Spain almirall.com ↗
Spanish health authorities grant regulatory approval for Sativex ® , the first new treatment for MS-related spasticity in decades |
| 2010-05-20 | Almirall, S.A. | Regulatory Regulators in UK and Spain confirm Sativex® is approvable almirall.com ↗
Sativex ® receives positive recommendation and process enters national approval phase in UK and Spain . |
| 2009-05-20 | Almirall, S.A. | Regulatory Almirall announces filing Sativex® regulatory submission almirall.com ↗ |
All press releases naming this drug 20 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 64 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nabiximols | “Nabiximols (Nabiximols is the U.S. Adopted Name [USAN] for Sativex [GW Pharma Ltd, Wiltshire, U.K.], which does not yet have an INN), a novel cannabinoid formulation, is...” PMID 22483680 ↗ Apr 201220“Nabiximols (trade name Sativex®) is an oromucosal spray formulation containing 1:1 fixed ratio of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) derived from cloned...” NCT03186664 ↗ “nabiximols (Sativex, GW Pharma Ltd. Salisbury, UK), an oromucosal spray primarily containing delta‐9‐tetrahydrocannabinol (THC) and cannabidiol (CBD).” PMID 21671456 ↗ Apr 2011 “a standardised oromucosal spray (nabiximols) containing a defined combination of delta-9-tetrahydrocannabinol and cannabidiol” PMID 30554828 ↗ Dec 2018 “with symptoms of spasticity due to multiple sclerosis who are receiving long-term Sativex® (nabiximols).” PMID 21878454 ↗ Aug 2011 “Sativex(®) (nabiximols) as an add-on therapy in alleviating bladder symptoms in patients with MS.” PMID 20829244 ↗ Sep 2010 “Δ9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray (Sativex (®), nabiximols)” PMID 23750331 ↗ May 2013 “(USAN name, nabiximols; Sativex, GW Pharmaceuticals, Salisbury, Wiltshire, UK)” PMID 23180178 ↗ Nov 2012 “study of nabiximols* (Sativex(®) ), as add-on therapy” PMID 21362108 ↗ Mar 2011 “(U.S. Adopted Name, nabiximols; Sativex(®))” PMID 23141881 ↗ Nov 2012 |
| Known as | Cannabis Based Medicine Extract | “This is a 10-week, randomised, double blind, placebo-controlled, crossover trial to investigate the effect of Cannabis Based Medicine Extract (Sativex) on patterns of brain...” NCT00202423 ↗ |
| Known as | Cannabis sativa L., folium cum flore | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04820361 ↗ |
| Known as | GW 1000 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833333 ↗ |
| Known as | GW-1000-02 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01606202 ↗ |
| Known as | Nabidiolex | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833333 ↗ |
| Known as | SAB378 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00723918 ↗ |
| Known as | Sativex | “nabiximols (Sativex, GW Pharma Ltd. Salisbury, UK), an oromucosal spray primarily containing delta‐9‐tetrahydrocannabinol (THC) and cannabidiol (CBD).” PMID 21671456 ↗ Apr 2011 |
| Known as | Tetranabinex | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833333 ↗ |
| Modality | Other / unclassified | “THC/CBD oromucosal spray, a novel cannabinoid formulation” PMID 24420962 ↗ Jan 2014 |
| Route | Other | “THC/CBD oromucosal spray” PMID 23180178 ↗ Nov 2012 |