levorphanol tartrate
Trade name: levo-dromoran
Approved
Jan 8, 1953
Levorphanol is an opioid medication used to treat moderate to severe pain. It is the levorotatory enantiomer of the compound racemorphan. Its dextrorotatory counterpart is dextrorphan. — Wikipedia
Clinical trial activity
2 trials · 3 clinical orgs · 8 marketing orgs
Earliest trial started Mar 1, 2001 (NCT00275249)
Timeline
1950s
- Jan 8, 1953
Bausch Health Companies — Earliest FDA Approval
- Jan 8, 1953
Bausch Health Companies — NDA Secondary Org
- Jan 8, 1953
Bausch Health Companies — NDA Organization
2000s
- Mar 31, 2000
Sentynl Theraps Inc — Marketing Organization
- Mar 31, 2000
Hikma — Marketing Organization
2010s
- Jan 1, 2018
Earliest Phase 1 Sponsor(trial)
- Dec 13, 2018
Virtus Pharms — Marketing Organization
- Dec 13, 2019
Specgx Llc — Marketing Organization
- Dec 13, 2019
Mallinckrodt (2013) — Marketing Organization
2020s
- Jul 1, 2020
Novitium Pharma — Marketing Organization
- Jun 17, 2021
Sun Pharmaceuticals — Marketing Organization
Indications
Approved for
Mechanism of action
- Mu opioid receptorAGONIST
OPRM agonist
Approval history
- approvedPriority reviewJan 8, 1953
Chemistry & pharmacology
SMILES
CN1CC[C@]23CCCC[C@H]2[C@H]1Cc1ccc(O)cc13.O.O.O=C(O)C(O)C(O)C(=O)O- Mol. weight
- 443.49 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Parenteral
- Availability
- Prescription Only
Oral
Yes
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL3989768 ↗
- WikipediaLevorphanol ↗
- ChEMBLCHEMBL592 ↗
- NCATSV7R79HN3XD ↗
- NCATS27618J1N2X ↗
- ChEMBLCHEMBL2062261 ↗
- ChEMBLCHEMBL20803 ↗
Also known as
- aromarone
- dromoran
- dromoran
- dromoran
- levo-dromoran
- levo-dromoran
- levo-dromoran
- levorfanol
- levorfanol
- levorfanolo
- levorfanolo
- levorphan
- levorphanol
- levorphanol
- levorphanol
- levorphanol
- levorphanol
- levorphanol
- levorphanol
- levorphanol
- levorphanol
- levorphanol
- lévorphanol
- lévorphanol
- levorphanol tartrate
- levorphanol tartrate
- levorphanol tartrate
- levorphanol tartrate
- levorphanolum
- levorphanolum
- n-methyl-3-hydroxymorphinan
- racemorphan
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT03579446 | Early Phase 1 (Phase 1) | Nov 30, 2018 | National Cancer Institute (NCI), University of Texas at Houston |
| NCT00275249 | N/A | Mar 1, 2001 | University of California, San Francisco |
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Government | 1 | 0 | 1 | 2018 |
| University of California, San Francisco | Academic/Hospital | 1 | 1 | 1 | 2001 |
| University of Texas at Houston | Academic/Hospital | 1 | 1 | 1 | 2018 |
Marketing (10)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bausch Health Companies | For profit | NDA2 | Jan 8, 1953 |
| Bausch Health Companies | For profit | NDA | Jan 8, 1953 |
| Hikma | For profit | MKTG | Mar 31, 2000 |
| Mallinckrodt (2013) | For profit | MKTG | Dec 13, 2019 |
| Novitium Pharma | For profit | MKTG | Jul 1, 2020 |
| Sentynl Theraps Inc | For profit | MKTG | Mar 31, 2000 |
| Specgx Llc | For profit | MKTG | Dec 13, 2019 |
| Sun Pharmaceuticals | For profit | MKTG | Jun 17, 2021 |
| Virtus Pharms | For profit | MKTG | Dec 13, 2018 |
| Virtus Pharms | For profit | SYN | Dec 13, 2018 |