calfactant
Trade name: infasurf
Small moleculeapprovedOrphan Drug FDA
Approved
Jul 1, 1998
Calfactant, also known as Infasurf, is an intratracheal suspension derived from the natural surfactant in calf lungs. It is used in premature infants with lung surfactant deficiency that causes infant respiratory distress syndrome (IRDS). — Wikipedia
Clinical trial activity
14 trials · 22 clinical orgs · 1 marketing orgs
Phase 1
2
Phase 2
7
Phase 3
6
Phase 4
0
Earliest trial started Jun 1, 2003 (NCT00165074)
Timeline
Indications
Mechanism of action
- Unspecified targetOTHER
Surfactant agent
Replaces endogenous surfactant in case of deficiency; endogenous pulmonary surfactant lower surface tension at the air-liquid of the alveolar surfaces
- Unspecified targetSurfactant
Surfactant
Replaces endogenous surfactant in case of deficiency; endogenous pulmonary surfactant lower surface tension at the air-liquid of the alveolar surfaces
Approval history
- approvedJul 1, 1998
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaCalfactant ↗
- NCATSQ4K217VGA9 ↗
- ChEMBLCHEMBL1201447 ↗
Also known as
- bovactant
- calfactant
- calfactant
- calfactant
- calfactant
- calfactant
- calfactant
- calfactant
- calfactant
- calfactant
- calf lung surfactant extract (clse)
- infasurf
- infasurf
- infasurf
- infasurf
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06841640 | Phase 1/Phase 2 (Phase 2) | Jan 15, 2025 | AeroRx Therapeutics Inc., Medicines Evaluation Unit Ltd |
| NCT05960929 | Phase 3 | Oct 1, 2023 | Avania, ONY |
| NCT03748173 | Phase 1 | Jan 12, 2019 | ONY |
| NCT03058666 | Phase 3 | Mar 29, 2017 | AHRM, Albany Medical College, ONY |
| NCT02834624 | N/A | Jul 1, 2013 | University of Missouri |
| NCT01268215 | Phase 2 | Jul 1, 2010 | East Carolina University |
| NCT00999713 | Phase 2/Phase 3 (Phase 3) | Jun 1, 2010 | Pennsylvania State University |
| NCT01022580 | Phase 3 | Jan 1, 2010 | National Heart, Lung, and Blood Institute (NHLBI), University of California, San Francisco |
| NCT00682500 | Phase 3 | May 1, 2008 | Pneuma Pharmaceuticals Incorporated, University of Virginia |
| NCT00628134 | N/A | Mar 1, 2008 | Cystic Fibrosis Foundation Therapeutics, University of Pittsburgh |
| NCT00569530 | Phase 3 | Jan 1, 2008 | Mallinckrodt, ONY, University of California, San Francisco |
| NCT00208039 | N/A | Sep 1, 2004 | Alta Bates Summit Medical Center, Northwell Health, State University of New York, Buffalo, University of California, San Francisco, University of Kansas, University of Pennsylvania, Washington University in St. Louis |
| NCT00165074 | N/A | Jun 1, 2003 | State University of New York, Buffalo, University of California, San Francisco, University of Pennsylvania |
| NCT03582930 | N/A | — | Albany Medical College, ONY |
Showing 14 of 14 trials
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Organizations
Research & Development (22)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| ONY | For profit | 5 | 4 | 3 | 2008 |
| University of California, San Francisco | Academic/Hospital | 4 | 2 | 2 | 2003 |
| Albany Medical College | Academic/Hospital | 2 | 0 | 2 | 2017 |
| State University of New York, Buffalo | Academic/Hospital | 2 | 0 | 1 | 2003 |
| University of Pennsylvania | Academic/Hospital | 2 | 2 | 1 | 2003 |
| AeroRx Therapeutics Inc. | For profit | 1 | 1 | 1 | 2025 |
| AHRM | Academic/Hospital | 1 | 0 | 1 | 2017 |
| Alta Bates Summit Medical Center | Academic/Hospital | 1 | 0 | 1 | 2004 |
| Avania | For profit | 1 | 0 | 1 | 2023 |
| Cystic Fibrosis Foundation Therapeutics | Academic/Hospital | 1 | 0 | 1 | 2008 |
| East Carolina University | Academic/Hospital | 1 | 1 | 1 | 2010 |
| Mallinckrodt | For profit | 1 | 0 | 1 | 2008 |
| Medicines Evaluation Unit Ltd | For profit | 1 | 0 | 1 | 2025 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 1 | 0 | 1 | 2010 |
| Northwell Health | Academic/Hospital | 1 | 0 | 1 | 2004 |
| Pennsylvania State University | Academic/Hospital | 1 | 1 | 1 | 2010 |
| Pneuma Pharmaceuticals Incorporated | For profit | 1 | 1 | 1 | 2008 |
| University of Kansas | Academic/Hospital | 1 | 0 | 1 | 2004 |
| University of Missouri | Academic/Hospital | 1 | 1 | 1 | 2013 |
| University of Pittsburgh | Academic/Hospital | 1 | 1 | 1 | 2008 |
22 organizations
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