CDEK
← All drugs Report issue

carisoprodol

Trade name: soma

Small moleculeapproved

Approved

Apr 9, 1959

A centrally acting skeletal muscle relaxant whose mechanism of action is not completely understood but may be related to its sedative actions. Carisoprodol is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Most common adverse reactions (incidence > 2%) are drowsiness, dizziness, and headache. Carisoprodol might be mixtured with Aspirin and Codeine Phosphate. Studies indicating increased risk of abuse or addiction led to withdrawal of the drug from the market in Norway and other EU countries in 2008. — NCATS

Clinical trial activity

4 trials · 3 clinical orgs · 30 marketing orgs

Phase 1
0
Phase 2
4
Phase 3
4
Phase 4
0

Earliest trial started Apr 1, 2008 (NCT00671502)

Timeline

1950s

  1. Apr 9, 1959

    Mylan — Earliest FDA Approval

  2. Apr 9, 1959

    Mylan — NDA Secondary Org

  3. Apr 9, 1959

    Mylan — NDA Organization

1960s

  1. Sep 12, 1960

    Meda Pharmaceuticals — Marketing Organization

  2. Sep 12, 1960

    Meda Pharmaceuticals — NDA Secondary Org

1970s

  1. Jun 12, 1979

    Teva — Marketing Organization

1980s

  1. Apr 20, 1982

    Watson Pharmaceuticals — Marketing Organization

  2. Mar 31, 1989

    Heritage Pharma — Marketing Organization

  3. Mar 31, 1989

    Chartwell Pharmaceuticals — Marketing Organization

  4. Apr 13, 1989

    Fosun — Marketing Organization

  5. Apr 13, 1989

    WANBANG BIOPHARMS — Marketing Organization

1990s

  1. Jan 24, 1996

    Hikma — Marketing Organization

  2. Apr 16, 1996

    Sandoz — Marketing Organization

  3. Apr 16, 1996

    Novartis — Marketing Organization

  4. Apr 25, 1996

    Genus Oncology, LLC — Marketing Organization

  5. Mar 7, 1997

    Oxford Pharmaceuticals — Marketing Organization

  6. Sep 8, 1997

    Mylan — Marketing Organization

  7. Sep 8, 1997

    Vintage — Marketing Organization

  8. Sep 8, 1997

    Allied Pharmaceutical Services — Marketing Organization

2000s

  1. Sep 21, 2000

    Epic Pharma Llc — Marketing Organization

  2. Jun 21, 2001

    Able Laboratories — Marketing Organization

  3. Jun 7, 2005

    AccelRx Research — Marketing Organization

  4. Feb 27, 2007

    Sun Pharmaceuticals — Marketing Organization

  5. Jan 1, 2008

    Earliest Phase 3 Sponsor(trial)

  6. Oct 22, 2008

    Novast Labs — Marketing Organization

  7. Aug 6, 2009

    Aurobindo Pharma — Marketing Organization

2010s

  1. Jan 7, 2010

    Ingenus Pharmaceuticals — Marketing Organization

  2. Jan 27, 2014

    Sciegen Pharmaceticals — Marketing Organization

  3. Oct 27, 2014

    Orient Pharma Co., Ltd. — Marketing Organization

  4. Oct 28, 2014

    Natco Pharma — Marketing Organization

  5. Jul 8, 2015

    Wilshire Pharmaceuticals — Marketing Organization

  6. Nov 12, 2015

    Strides Pharma Science — Marketing Organization

  7. May 11, 2017

    Nostrum Laboratories — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Unknown

Combination products

Approval history

  • approvedApr 9, 1959

Chemistry & pharmacology

Loading structure…

SMILES

CCCC(C)(COC(N)=O)COC(=O)NC(C)C
Mol. weight
260.33 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Prodrug

Sources

Also known as

  • (1-methylethyl)carbamic acid 2-(((aminocarbonyl)oxy)methyl)-2-methylpentyl ester
  • (1-methylethyl)carbamic acid 2-(((aminocarbonyl)oxy)methyl)-2-methylpentyl ester
  • (+-)-2-methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate
  • (+-)-2-methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate
  • 2-methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate
  • 2-methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate
  • 2-methyl-2-propyltrimethylene carbamate isopropylcarbamate
  • 2-methyl-2-propyltrimethylene carbamate isopropylcarbamate
  • carbamic acid 2-isopropylcarbamoyloxymethyl-2-methyl-pentyl ester
  • carbamic acid 2-isopropylcarbamoyloxymethyl-2-methyl-pentyl ester
  • carisoma
  • carisoma
  • carisoprodate
  • carisoprodate
  • carisoprodate
  • carisoprodol
  • carisoprodol
  • carisoprodol
  • carisoprodol
  • carisoprodol
  • carisoprodol
  • carisoprodol
  • carisoprodol
  • carisoprodol
  • carisoprodol
  • carisoprodol
  • carisoprodol
  • carisoprodolum
  • carisoprodolum
  • isobamate
  • isobamate
  • isomeprobamate
  • isomeprobamate
  • isomeprobamate
  • isopropylmeprobamate
  • isopropylmeprobamate
  • isopropyl meprobamate
  • isopropyl meprobamate
  • isopropyl meprobamate
  • n-isopropy-2-methyl-2-propyl-1,3-propanediol dicarbamate
  • n-isopropy-2-methyl-2-propyl-1,3-propanediol dicarbamate
  • rela
  • rela
  • (rs)-2-{[(aminocarbonyl)oxy]methyl}-2-methylpentyl isopropylcarbamate
  • (rs)-2-{[(aminocarbonyl)oxy]methyl}-2-methylpentyl isopropylcarbamate
  • soma
  • soma
  • soma
  • someprobamate
  • someprobamate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03508167Phase 3Apr 1, 2019Ache Laboratorios Farmaceuticos S.A.
NCT01421433Phase 3May 1, 2012Farmoquimica S.A.
NCT00671502Phase 3Apr 1, 2008Meda
NCT00671879Phase 3Apr 1, 2008Meda
Showing 4 of 4 trials
Page 1 / 1

Organizations

Research & Development (3)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MedaFor profit2212008
Ache Laboratorios Farmaceuticos S.A.For profit1112019
Farmoquimica S.A.For profit1112012
3 organizations
Page 1 / 1

Marketing (35)

OrganizationOrg typeRelationshipDate
Able LaboratoriesFor profitMKTGJun 21, 2001
AccelRx ResearchFor profitMKTGJun 7, 2005
Allied Pharmaceutical ServicesFor profitMKTGSep 8, 1997
Aurobindo PharmaFor profitMKTGAug 6, 2009
Chartwell PharmaceuticalsFor profitMKTGMar 31, 1989
Dow ChemicalFor profitMKTG—
Epic Pharma LlcFor profitMKTGSep 21, 2000
FosunFor profitMKTGApr 13, 1989
Genus Oncology, LLCFor profitMKTGApr 25, 1996
Heritage PharmaFor profitMKTGMar 31, 1989
HikmaFor profitMKTGJan 24, 1996
Ingenus PharmaceuticalsFor profitMKTGJan 7, 2010
Meda PharmaceuticalsFor profitMKTGSep 12, 1960
Meda PharmaceuticalsFor profitNDA2Sep 12, 1960
MylanFor profitMKTGSep 8, 1997
MylanFor profitNDA2Apr 9, 1959
MylanFor profitNDAApr 9, 1959
Natco PharmaFor profitSYNOct 28, 2014
Natco PharmaFor profitMKTGOct 28, 2014
Nostrum LaboratoriesFor profitMKTGMay 11, 2017
NovartisFor profitMKTGApr 16, 1996
Novast LabsFor profitMKTGOct 22, 2008
Orient Pharma Co., Ltd.For profitMKTGOct 27, 2014
Oxford PharmaceuticalsFor profitMKTGMar 7, 1997
SandozFor profitMKTGApr 16, 1996
ScheringFor profitNDA2—
Sciegen PharmaceticalsFor profitMKTGJan 27, 2014
Strides Pharma ScienceFor profitMKTGNov 12, 2015
Sun PharmaceuticalsFor profitMKTGFeb 27, 2007
Sun PharmaceuticalsFor profitSYNOct 17, 1991
TevaFor profitMKTGJun 12, 1979
VintageFor profitMKTGSep 8, 1997
WANBANG BIOPHARMSFor profitMKTGApr 13, 1989
Watson PharmaceuticalsFor profitMKTGApr 20, 1982
Wilshire PharmaceuticalsFor profitMKTGJul 8, 2015