Statements (104)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:pharmaceuticals
|
| gptkbp:approves |
gptkb:2022
gptkb:U._S._Food_and_Drug_Administration_(FDA) |
| gptkbp:availability |
prescription only
U. S. market |
| gptkbp:availability_in_other_countries |
pending in some regions
|
| gptkbp:awards |
received for innovation in ALS treatment
|
| gptkbp:brand |
gptkb:Relyvrio
|
| gptkbp:class |
neuroprotective agents
orphan drug |
| gptkbp:clinical_trial |
gptkb:Amylyx_Pharmaceuticals
gptkb:PHOENIX_trial ongoing studies published in medical journals Phase 2/3 specific criteria apply multiple sites in North America showed a slowing of functional decline in ALS patients specific to ALS diagnosis ALSYMPCA study various sites across the U. S. |
| gptkbp:clinical_trial_phases_completed |
Phase 1, Phase 2, Phase 3
|
| gptkbp:clinical_trial_results_publication |
published in medical journals
|
| gptkbp:collaborations |
with academic institutions
|
| gptkbp:community_health |
available resources
important for prescribing |
| gptkbp:contraindication |
hypersensitivity to components
hypersensitivity to any component of the product |
| gptkbp:dosage_form |
gptkb:liquid
powder for oral suspension |
| gptkbp:drug_approval_process |
involves multiple phases
|
| gptkbp:drug_interactions |
none known
may interact with other medications |
| gptkbp:duration |
ongoing
|
| gptkbp:eligibility |
ongoing for studies
|
| gptkbp:feedback |
generally positive
generally positive regarding efficacy |
| gptkbp:financial_support |
available
available for users |
| gptkbp:formulation |
oral solution
oral powder |
| gptkbp:funding |
supported by grants
|
| gptkbp:healthcare |
assistance programs available
liquid solution |
| gptkbp:healthcare_provider_support |
training programs available
|
| https://www.w3.org/2000/01/rdf-schema#label |
Relyvrio
|
| gptkbp:ingredients |
gptkb:sodium_phenylbutyrate
taurursodiol |
| gptkbp:is_monitored_by |
recommended during treatment
|
| gptkbp:launch_date |
September 2022
|
| gptkbp:manufacturer |
gptkb:Amylyx_Pharmaceuticals
Amylyx Pharmaceuticals, Inc. |
| gptkbp:market |
ongoing monitoring
|
| gptkbp:marketed_as |
gptkb:Canada
gptkb:United_States gptkb:Amylyx_Pharmaceuticals September 2022 |
| gptkbp:mechanism_of_action |
modulates cellular stress response
modulates neuroprotective pathways |
| gptkbp:packaging |
gptkb:bottle
single-dose packets |
| gptkbp:patient_education |
provided by manufacturer
important for understanding treatment |
| gptkbp:patient_population |
adults with ALS
|
| gptkbp:patient_support_resources |
available online
|
| gptkbp:pharmacokinetics |
absorbed in the gastrointestinal tract
affects cellular pathways involved in neuroprotection absorption varies involves neuroprotective effects |
| gptkbp:previous_name |
sodium phenylbutyrate and taurursodiol
|
| gptkbp:price |
varies by insurance
varies by insurance coverage |
| gptkbp:provides_guidance_on |
recommended for ALS treatment
included in ALS treatment guidelines |
| gptkbp:publication |
peer-reviewed articles available
|
| gptkbp:publications |
related to ALS research
|
| gptkbp:regulatory_compliance |
FDA approved
|
| gptkbp:related_products |
gptkb:riluzole
gptkb:edaravone |
| gptkbp:requires |
gptkb:true
available on the manufacturer's website |
| gptkbp:research_focus |
gptkb:neurodegenerative_diseases
|
| gptkbp:route_of_administration |
oral
|
| gptkbp:safety_features |
generally well tolerated
monitored post-marketing |
| gptkbp:side_effect |
fatigue
nausea abdominal pain vomiting decreased appetite diarrhea monitoring required reported in clinical trials |
| gptkbp:storage |
room temperature
store at room temperature |
| gptkbp:supply_chain |
managed by manufacturer
|
| gptkbp:treatment |
improved survival rates
evaluated in studies assessed in clinical trials tracked in ongoing studies |
| gptkbp:type_of_care |
important for efficacy
important for treatment efficacy |
| gptkbp:type_of_insurance |
varies by plan
|
| gptkbp:used_for |
treatment of amyotrophic lateral sclerosis (ALS)
|