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Nabiximols · Sativex

Botanical

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Negativelead readout

Evidence outlook · lead readout

RELEASE MSS1 (NCT04657666) · Spasticity in Participants With Multiple Sclerosis

The lead readout missed its primary endpoint. The grade and rationale below record what the trial was designed to show and what it found.

RELEASE MSS1 (NCT04657666): The study randomized 68 participants to receive nabiximols and matching placebo in a blinded crossover design. Its clinical primary endpoint was not met: lower-limb muscle tone improved by a similar amount with nabiximols and placebo, with p=0.7152.

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Competitive landscape

44 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 44 same-indication; 27 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Nabiximols (Sativex): this drugPhase 3BotanicalCannabinoid CB1/CB2 receptors (agonist)
Aldesleukin (Proleukin)ApprovedRecombinant Cytokine (il-2)Interleukin-2 receptor (IL-2R)
AlemtuzumabApprovedMonoclonal antibodyCD52
BafiertamApprovedSmall moleculeNrf2 pathway (fumaric acid ester)
Cladribine (MAVENCLAD®)ApprovedSmall moleculeAdenosine deaminase-resistant purine analog, DNA synthesis machinery in lymphocytes
CopaxoneApprovedPeptideMyelin basic protein-mimetic immunomodulation
Dimethyl Fumarate (Tecfidera)ApprovedSmall moleculeNrf2 pathway (fumaric acid ester)
Diroximel Fumarate (Vumerity)ApprovedSmall moleculeNrf2 pathway (fumaric acid ester)
DRFApprovedSmall moleculeNrf2 pathway (fumaric acid ester)
Fampridine (Ampyra / Fampyra)ApprovedSmall moleculePotassium Channel Blocker, Voltage-gated potassium channel (Kv), Voltage-gated potassium channels (Kv1/Shaker/KCNA family)
Fingolimod (Gilenya)ApprovedSmall moleculeSphingosine 1-phosphate receptor (S1PR, specifically S1P1), S1P receptor, Sphingosine-1-phosphate receptors (S1P1, S1P3, S1P4, S1P5)
Interferon Beta-1a (Avonex)ApprovedBiologic (subtype unspecified)Type I Interferon receptor (IFNAR)
Interferon Beta-1bApprovedBiologic (subtype unspecified)Interferon beta receptor (type I IFN signaling), Type I interferon receptor
Interferon-Beta1ApprovedBiologic (subtype unspecified)Type I interferon receptor
MayzentApprovedSmall moleculeS1P receptor
Natalizumab (Tysabri)ApprovedMonoclonal antibodyα4 integrin

…and 29 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(1 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2028 (1)
September 2028 (1)
Phase 2Neuropathic Pain, Peripheral Neuropathic PainRecruiting
Est. primary completion 2028-09-29 · NCT05351801 · CT.gov ↗
What to watch
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All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (33)
Phase 2/3 (1)
Phase 2 (6)
Phase 1/2 (2)
Phase 1 (12)
Phase 4 (1)
Early phase / not applicable (3)
Used as active comparator (3)