podofilox

Trade name: condylox

Botanicalapproved

Approved

Dec 13, 1990

Podofilox ((abbreviated as PPT), otherwise known as podofilox) is an antimitotic drug which can be chemically synthesized or purified from the plant families Coniferae and Berberidaceae (e.g. species of Juniperus and Podophyllum). Podofilox 0.5% solution is indicated for the topical treatment of external genital warts (Condyloma acuminatum). This product is not indicated in the treatment of perianal or mucous membrane warts. Treatment of genital warts with podofilox results in necrosis of visible wart tissue. The exact mechanism of action is unknown, but is believed to exert its antimitotic effect by binding to tubulin, at a site close to but not identical to the binding site of colchicine; it is thought that this antimitotic effect causes necrosis of wart tissue, the observed clinical effect. In addition, podofilox is known to interfere with nucleoside transport, which may also contribute to its action. Adverse effects reported in less than 5% of the patients included pain with intercourse, insomnia, tingling, bleeding, tenderness, chafing, malodor, dizziness, scarring, vesicle formation, crusting edema, dryness/peeling, foreskin irretraction, hematuria, vomiting and ulceration. — NCATS

Clinical trial activity

1 trials · 2 clinical orgs · 6 marketing orgs

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

Earliest trial started Apr 20, 2018 (NCT03532776)

Timeline

1990s

  1. Dec 13, 1990

    Allergan — Earliest FDA Approval

  2. Dec 13, 1990

    Allergan — Marketing Organization

  3. Dec 13, 1990

    Allergan — NDA Secondary Org

  4. Dec 13, 1990

    Allergan — NDA Organization

  5. Dec 13, 1990

    Teva — Marketing Organization

  6. Dec 13, 1990

    Teva — NDA Secondary Org

  7. Mar 13, 1997

    SmithKline Beecham — NDA Secondary Org

2000s

  1. Jan 29, 2002

    Paddock Laboratories — Marketing Organization

  2. Jan 29, 2002

    Padagis Us — Marketing Organization

2010s

  1. Jul 21, 2010

    Bausch & Lomb — Marketing Organization

  2. Jan 1, 2018

    Earliest Phase 3 Sponsor(trial)

Indications

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Unknown

    Microtubule inhibitor, but this is likely not the mode of action against HPV

Approval history

  • approvedPriority reviewDec 13, 1990

Chemistry & pharmacology

Loading structure…

SMILES

COC1=CC(=CC(OC)=C1OC)[C@H]2[C@@H]3[C@H](COC3=O)[C@@H](O)C4=CC5=C(OCO5)C=C24
Mol. weight
414.4053 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • 9-hydroxy-5-(3,4,5-trimethoxyphenyl)-5,8,8a,9-tetrahydrofuro[3',4':6,7]naphtho[2,3-d][1,3]dioxol-6(5ah)-one
  • 9-hydroxy-5-(3,4,5-trimethoxyphenyl)-5,8,8a,9-tetrahydrofuro[3',4':6,7]naphtho[2,3-d][1,3]dioxol-6(5ah)-one
  • condyline
  • condyline
  • condyline
  • condylox
  • condylox
  • condylox
  • podofilox
  • podofilox
  • podofilox
  • podofilox
  • podofilox
  • podofilox
  • podofilox
  • podophyllinic acid lactone
  • podophyllinic acid lactone
  • podophyllotoxin
  • podophyllotoxin
  • podophyllotoxin
  • podophyllotoxin
  • podophyllotoxin
  • podophyllotoxin
  • podophyllotoxin
  • (-)-podophyllotoxin
  • (-)-podophyllotoxin
  • podophyllotoxin 7
  • podophyllotoxin 7
  • podophyllum
  • podophyllum
  • podophyllum
  • ppt
  • ppt
  • warticon
  • warticon

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03532776Phase 3Apr 20, 2018bioRASI, LLC, Hyloris Developments SA
Showing 1 of 1 trials
Page 1 / 1

Organizations

Research & Development (2)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
bioRASI, LLCFor profit1112018
Hyloris Developments SAFor profit1012018
2 organizations
Page 1 / 1

Marketing (9)

OrganizationOrg typeRelationshipDate
AllerganFor profitMKTGDec 13, 1990
AllerganFor profitNDA2Dec 13, 1990
AllerganFor profitNDADec 13, 1990
Bausch & LombFor profitMKTGJul 21, 2010
Padagis UsFor profitMKTGJan 29, 2002
Paddock LaboratoriesFor profitMKTGJan 29, 2002
SmithKline BeechamFor profitNDA2Mar 13, 1997
TevaFor profitMKTGDec 13, 1990
TevaFor profitNDA2Dec 13, 1990