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Search results for "ORPHAN DRUG" in comments (approximate match)
Status:
Designated
Source:
FDA ORPHAN DRUG:304110
Source URL:
Class:
PROTEIN
Homspera is a synthetic analog of the naturally occurring human neuropeptide Substance P, which can be found throughout the body, including in the airways of humans and many other species. Substance P has been shown to stimulate cellular growth in cell culture, and it was shown that Substance P could promote wound healing of non-healing ulcers in humans. Homspera to be effective in treating the pulmonary injury as well as mitigating acute effects, including the hematopoietic syndrome, resulting from exposure to ionizing radiation. Homspera to be effective in stimulating human, adult, blood-forming stem cells (hematopoietic stem cells), which have previously been shown to be capable of becoming blood cells that are vital to the body’s immune system. Homspera may have potential benefit in situations where regenerating or stimulating the immune system is desired, as with patients undergoing chemotherapy who may develop leukopenia
Status:
Designated
Source:
FDA ORPHAN DRUG:74893
Source URL:
Class:
PROTEIN
Status:
Designated
Source:
FDA ORPHAN DRUG:205505
Source URL:
Class:
PROTEIN
Contulakin-G is the synthetic form of a natural peptide extracted from the venom of the Conus Geographus sea snail that used in animal models as a broad-spectrum non-opioid analgesic. Contulakin-G was previously shown to be an agonist for all three subtypes of neurotensin receptors, NTS1, NTS2, and NTS3 with submicromolar potency. Contulakin-G exhibited potent analgesic activity in three pain models in rats following intrathecal delivery, namely in tail-flick (acute pain), formalin test, and CFA-induced allodynia inflammatory pain. Contulakin-G (coded as CGX-1160) was granted an orphan drug designation by the US Food and Drug Administration (FDA) and reached a clinical development stage for the treatment of chronic intractable pain following intrathecal administration in patients with spinal cord injury
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(8)(ii) digestive aid stem bromelain
Source URL:
First approved in 2021
Source:
21 CFR 333D
Source URL:
Class:
PROTEIN
Status:
US Previously Marketed
Source:
SURFAXIN
(2012)
Source URL:
First approved in 2012
Source:
SURFAXIN
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Sinapultide is a synthetic peptide used to mimic human lung surfactant protein B, the most important surfactant protein for a proper functioning of the respiratory system. Protein B lowers surface tension at the air-liquid interface of the alveolar surfaces during respiration and stabilizes the alveoli against collapse at resting transpulmonary pressures. A deficiency of pulmonary surfactant in premature infants results in respiratory distress syndrome. Sinapultide compensates for the deficiency of surfactant and restores surface activity to the lungs of these infants. Sinapultide was originally developed in the Scripps Research Institute and then licensed to Windtree Therapeutics (formerly Discovery Laboratories, Inc.). Sinapultide is the active ingredient of Lucinactant, a liquid medication to treat infant respiratory distress syndrome. Lucinactant was approved by the FDA in 2012 and sold under the trademark Surfaxin, but in 2015 it was discontinued by Discovery Laboratories, Inc in favor of Aerosurf, another drug containing Sinapultide.
Status:
US Previously Marketed
Source:
IPLEX by INSMED
(2005)
Source URL:
First approved in 2005
Source:
IPLEX by INSMED
Source URL:
Class:
PROTEIN
Status:
US Previously Marketed
Source:
Bexxar
(2003)
Source URL:
First approved in 2003
Source:
Bexxar
Source URL:
Class:
PROTEIN
Status:
US Previously Marketed
Source:
Amevive
(2003)
Source URL:
First approved in 2003
Source:
Amevive
Source URL:
Class:
PROTEIN
Status:
US Previously Marketed
Source:
Xigris
(2001)
Source URL:
First approved in 2001
Source:
Xigris
Source URL:
Class:
PROTEIN
Status:
US Previously Marketed
Source:
Refludan
(1998)
Source URL:
First approved in 1998
Source:
Refludan
Source URL:
Class:
PROTEIN
Conditions:
Lepirudin is a direct thrombin inhibitor obtained by recombinant technology from the medicinal leech and used for treatment of heparin-induced thrombocytopenia (HIT). Lepirudin was the first direct thrombin inhibitor approved and most frequently used for the treatment of patients with HIT. The efficacy of lepirudin for HIT has been shown to improve general outcomes in patients with HIT, reducing a primary composite endpoint of new thrombosis, all-cause amputation, and all-cause death. Lepirudin forms a stable non-covalent complex with alpha-thrombin, thereby abolishing its ability to cleave fibrinogen and initiate the clotting cascade. It is a highly potent, selective, and essentially irreversible inhibitor of thrombin and clot-bond thrombin. Lepirudin is identical to natural hirudin except for substitution of leucine for isoleucine at the N-terminal end of the molecule and the absence of a sulfate group on the tyrosine at position 63.