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CAS No. :	410528-02-8
Formula :	C₂₇H₃₀N₂O₂
M.W :	414.54
SMILES Code :	O=C(O)C1=CC=C(/C=C/C2=C(CN3N=CC=C3)C=C4C(C)(C)CCC(C)(C)C4=C2)C=C1
Synonyms :	R 667; Ro 3300074
MDL No. :	MFCD10565968
InChI Key :	YTFHCXIPDIHOIA-DHZHZOJOSA-N
Pubchem ID :	10295295

GHS Pictogram:
Signal Word:	Warning
Hazard Statements:	H302-H315-H319-H335
Precautionary Statements:	P261-P280-P301+P312-P302+P352-P305+P351+P338

R206H-FAPs	10 nM	10 days	To evaluate the inhibitory effect of palovarotene on chondrogenic differentiation of R206H-FAPs. Results showed that palovarotene significantly inhibited chondrogenic differentiation of R206H-FAPs, with efficacy comparable to anti-activin A antibody.	Elife. 2018 Sep 18;7:e40814
Coculture system of TSCs and macrophages	0.5, 1, 2 µM	14 days	To simulate the inflammatory microenvironment and assess the effect of Palovarotene on osteogenic differentiation of TSCs. Results showed that the inflammatory microenvironment promoted osteogenic differentiation of TSCs, which could be inhibited by Palovarotene in a concentration-dependent manner.	Stem Cells Int. 2022 Apr 28;2022:1560943
HUVEC cells	1 µM	14-21 days	Inhibited BMP4-induced EC-to-OSB transition, as indicated by reduced Alizarin Red staining	Cancer Res. 2022 Sep 2;82(17):3158-3171.
Chondrocytes	300 nM	24 hours	Investigate the activation of Stat3 signaling pathway by Palovarotene, results showed significant stimulation of Stat3 phosphorylation	Int J Mol Sci. 2024 Jul 11;25(14):7610
Bone marrow stromal cells (BMSCs)	15 nM, 60 nM, 125 nM	24 hours	To evaluate the effect of Palovarotene on the transcriptional activity of RARE reporter constructs. Results showed that Palovarotene significantly increased RARE reporter activity by nearly 3-fold at 15 nM and 60 nM doses.	Bone. 2016 Sep;90:59-68
Tendon stem cells (TSCs)	0.5, 1, 2 µM	24, 48, 72 hours	To evaluate the effect of Palovarotene on TSCs proliferation and determine the suitable administration range. Results showed that Palovarotene at 0.5, 1, 2 μM had minimal effect on TSCs proliferation.	Stem Cells Int. 2022 Apr 28;2022:1560943
Primary growth plate chondrocytes	50 nM	4 and 7 days	To evaluate the effect of Palovarotene on chondrocyte differentiation. Results showed that Palovarotene inhibited the chondrogenic and chondrocyte phenotype, as indicated by a significant drop in Alcian blue staining of the extracellular matrix and a steep drop in gene expression levels for Sox9, Acan, and Col2a1. However, Palovarotene treatment did not have obvious inhibitory effects on Inhba expression.	JBMR Plus. 2023 Oct 19;7(12):e10821
Human osteochondroma cells	300 nM	4 or 7 days	To evaluate the effects of RARγ agonists on human osteochondroma cells, results showed inhibition of cartilage matrix synthesis, promotion of matrix degradation, and stimulation of cell death.	Int J Mol Sci. 2020 Apr 13;21(8):2686
2H11 cells	1 µM	48 hours	Inhibited BMP4-induced EC-to-OSB transition, as shown by reduced OSX and osteocalcin expression and inhibition of osteoblast mineralization	Cancer Res. 2022 Sep 2;82(17):3158-3171.

Mice	Fsp1Cre;Ext1flox/flox model	Oral gavage	0.27, 0.88, 1.76 mg/kg/day	Daily administration from P14 to P42 (Experiment 1) or from P21 to P42 (Experiment 2)	PVO significantly inhibited osteochondroma formation in Fsp1Cre;Ext1flox/flox mice, with the highest dose group showing a 91.1% reduction in osteochondroma number. Delaying the initiation of treatment to P21 alleviated the inhibitory effect on long bone growth.	J Bone Miner Res. 2018 Apr;33(4):658-666
Mice	Subcutaneous HO mouse model induced by Matrigel plus rhBMP2	Oral	0.4 mg/kg/day or 4.0 mg/kg/day	Daily administration starting on the afternoon of day 1 post-implantation and continuing until day 10	To assess the inhibitory effect of Palovarotene on heterotopic ossification. Results demonstrated that high-dose Palovarotene (4.0 mg/kg/day) significantly inhibited HO, reduced cartilage and bone formation, and decreased the number of inflammatory cells (e.g., mast cells and macrophages).	Bone. 2016 Sep;90:59-68
Mice	FOP mouse model	Intraperitoneal injection	0.735 mg/kg and 1.47 mg/kg	Daily administration from postnatal day 14 to 41	To assess the effect of daily palovarotene treatment on heterotopic ossification in juvenile FOP mice. Results showed that palovarotene significantly reduced the severity of HO but caused pronounced skeletal toxicity, including growth plate loss and synovial joint overgrowth.	Elife. 2018 Sep 18;7:e40814
Mice	HSV-1 infection model	Injection	1 mg/kg	5 days	To evaluate the antiviral effect of Palovarotene against HSV-1 infection, results showed Palovarotene significantly inhibited HSV-1 replication in the mouse brain and spleen and improved survival rate.	iScience. 2024 Jun 4;27(7):110144
Male SD rats	Achilles tendon resection-induced HO model	Oral	1 mg/kg/day	Once daily for 21 days	To evaluate the inhibitory effect of Palovarotene on HO formation. Results showed that Palovarotene significantly inhibited HO formation, reduced macrophage aggregation, and suppressed the activation of Smad and NF-κB signaling pathways.	Stem Cells Int. 2022 Apr 28;2022:1560943
Sprague Dawley rats	Blast-related limb injury, femoral fracture, quadriceps crush injury, amputation and MRSA infection model	Oral	1 mg/kg/day	Every other day for 14 days	To evaluate the efficacy of Palovarotene in inhibiting heterotopic ossification in a blast-related trauma model. Results showed that Palovarotene significantly reduced HO by 50 to 60%, regardless of treatment initiation time or infection presence.	Bone. 2016 Sep;90:159-67
Mice	Multiple osteochondroma model	Oral gavage	1.76 to 4.0 mg/kg	Daily administration for 2 to 4 weeks	Evaluate the inhibitory effect of Palovarotene on the growth of pre-existing osteochondromas, results showed complete inhibition of tumor growth	Int J Mol Sci. 2024 Jul 11;25(14):7610
Mice	Mouse model carrying the human ACVR1R206H FOP mutation	Oral gavage	100 μg/mouse (day 1–3) and 15 μg/mouse (day 4–14)	Daily administration for 14 days	Palovarotene significantly inhibited heterotopic ossification, reduced hypertrophic chondrocytes, and improved skeletal growth and joint function	J Bone Miner Res. 2016 Sep;31(9):1666-75
SCID mice	C4-2b-BMP4 subcutaneous tumor model	Oral gavage	2 mg/kg/day	Once daily, throughout the treatment period	Reduced tumor-induced bone formation and tumor size	Cancer Res. 2022 Sep 2;82(17):3158-3171.
CD-1 mice	Acquired heterotopic ossification (HO) model	Gavage	4 mg/kg/day	Daily administration until the end of the experiment (days 5, 9, 12)	To evaluate the inhibitory effect of Palovarotene on heterotopic ossification. Results showed that Palovarotene significantly inhibited HO formation, reduced the number of local Inhba/activin A-expressing cell populations, and delayed cell migration into the central region of the Matrigel scaffold. Additionally, Palovarotene reduced the number of inflammatory cells (e.g., macrophages) that are known to participate in HO formation.	JBMR Plus. 2023 Oct 19;7(12):e10821

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CAS No.: 410528-02-8

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CAS No.: 410528-02-8

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NCT02521792	Fibrodysplasia Ossificans Prog... More >>ressiva Less <<	PHASE2	TERMINATED	2016-08-04	University of California San F... More >>rancisco, Division of Endocrinology and Metabolism, San Francisco, California, 94143, United States\|University of Pennsylvania, Center for Research in FOP & Related Disorders, Philadelphia, Pennsylvania, 19104, United States Less <<
NCT03312634	Fibrodysplasia Ossificans Prog... More >>ressiva Less <<	PHASE3	COMPLETED	2022-09-07	University of California San F... More >>rancisco, Division of Endocrinology and Metabolism, San Francisco, California, 94143, United States\|Mayo Clinic, Rochester, Minnesota, 55905, United States\|Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States\|University of Pennsylvania, Internal Medicine, Philadelphia, Pennsylvania, 19104, United States\|Hospital Italiano de Buenos Aires, Tte General Juan Domingo Peron 4190, Buenos Aires, C1199ACH, Argentina\|Royal North Shore Hospital, Saint Leonards, New South Wales, 2065, Australia\|Queensland University of Technology, Woolloongabba, Queensland, 4102, Australia\|Hospital Israelita Albert Einstein, Sao Paulo, SP, 05652-900, Brazil\|Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, M5G 1X8, Canada\|Toronto General Hospital, Toronto, Ontario, M5G 2C4, Canada\|Groupe Hospitalier Necker Enfants Malades, Paris, 75015, France\|Istituto Giannina Gaslini, Genoa, Liguria, 16147, Italy\|The University of Tokyo Hospital, Tokyo, Bunkyo-ku, 113-8655, Japan\|Hospital Universitari i Politècnic La Fe, Unidad de Reumatología Pediatrica, Valencia, Avinguda De Fernando Abril Martorell, No 106, 46026, Spain\|Norrlands Universitetssjukhus, Ume?, SE-90185, Sweden\|Royal National Orthopaedic Hospital, Brockely Hill, Stanmore, HA7 4LP, United Kingdom Less <<
NCT05027802	Fibrodysplasia Ossificans Prog... More >>ressiva (FOP) Less <<	PHASE3	COMPLETED	2024-11-30	University of California San F... More >>rancisco (UCSF), San Francisco, California, 94143, United States\|Mayo Clinic, Rochester, Minnesota, 55905, United States\|Children's Hospital of Philidelphia, Philadelphia, Pennsylvania, 19104, United States\|The Perelman School of Medicine - The University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States\|Hospital Italiano de Buenos Aires, Buenos Aires, C1181ACH, Argentina\|Royal North Shore Hospital, Saint Leonards, New South Wales, 2065, Australia\|Hospital Israelita Albert Einstein, Morumbi, Sao-Paulo, 05652-900, Brazil\|Toronto General Hospital, Toronto, M5T 2S8, Canada\|Groupe Hospitalier Necker Enfants Malades, Paris, 75015, France\|Istituto Giannina Gaslini, Genoa, 16147, Italy\|Hospital Universitario Ramon y Cajal, Colmenar Viejo, 28034, Spain\|Norrlands Universitetssjukhus, Ume?, 90737, Sweden\|Royal National Orthopaedic Hospital, London, HA7 4LP, United Kingdom Less <<

Precautionary Statements-General
Code	Phrase
P101	If medical advice is needed,have product container or label at hand.
P102	Keep out of reach of children.
P103	Read label before use
Prevention
Code	Phrase
P201	Obtain special instructions before use.
P202	Do not handle until all safety precautions have been read and understood.
P210	Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
P211	Do not spray on an open flame or other ignition source.
P220	Keep/Store away from clothing/combustible materials.
P221	Take any precaution to avoid mixing with combustibles
P222	Do not allow contact with air.
P223	Keep away from any possible contact with water, because of violent reaction and possible flash fire.
P230	Keep wetted
P231	Handle under inert gas.
P232	Protect from moisture.
P233	Keep container tightly closed.
P234	Keep only in original container.
P235	Keep cool
P240	Ground/bond container and receiving equipment.
P241	Use explosion-proof electrical/ventilating/lighting/equipment.
P242	Use only non-sparking tools.
P243	Take precautionary measures against static discharge.
P244	Keep reduction valves free from grease and oil.
P250	Do not subject to grinding/shock/friction.
P251	Pressurized container: Do not pierce or burn, even after use.
P260	Do not breathe dust/fume/gas/mist/vapours/spray.
P261	Avoid breathing dust/fume/gas/mist/vapours/spray.
P262	Do not get in eyes, on skin, or on clothing.
P263	Avoid contact during pregnancy/while nursing.
P264	Wash hands thoroughly after handling.
P265	Wash skin thouroughly after handling.
P270	Do not eat, drink or smoke when using this product.
P271	Use only outdoors or in a well-ventilated area.
P272	Contaminated work clothing should not be allowed out of the workplace.
P273	Avoid release to the environment.
P280	Wear protective gloves/protective clothing/eye protection/face protection.
P281	Use personal protective equipment as required.
P282	Wear cold insulating gloves/face shield/eye protection.
P283	Wear fire/flame resistant/retardant clothing.
P284	Wear respiratory protection.
P285	In case of inadequate ventilation wear respiratory protection.
P231 + P232	Handle under inert gas. Protect from moisture.
P235 + P410	Keep cool. Protect from sunlight.
Response
Code	Phrase
P301	IF SWALLOWED:
P304	IF INHALED:
P305	IF IN EYES:
P306	IF ON CLOTHING:
P307	IF exposed:
P308	IF exposed or concerned:
P309	IF exposed or if you feel unwell:
P310	Immediately call a POISON CENTER or doctor/physician.
P311	Call a POISON CENTER or doctor/physician.
P312	Call a POISON CENTER or doctor/physician if you feel unwell.
P313	Get medical advice/attention.
P314	Get medical advice/attention if you feel unwell.
P315	Get immediate medical advice/attention.
P320
P302 + P352	IF ON SKIN: wash with plenty of soap and water.
P321
P322
P330	Rinse mouth.
P331	Do NOT induce vomiting.
P332	IF SKIN irritation occurs:
P333	If skin irritation or rash occurs:
P334	Immerse in cool water/wrap n wet bandages.
P335	Brush off loose particles from skin.
P336	Thaw frosted parts with lukewarm water. Do not rub affected area.
P337	If eye irritation persists:
P338	Remove contact lenses, if present and easy to do. Continue rinsing.
P340	Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P341	If breathing is difficult, remove victim to fresh air and keep at rest in a position comfortable for breathing.
P342	If experiencing respiratory symptoms:
P350	Gently wash with plenty of soap and water.
P351	Rinse cautiously with water for several minutes.
P352	Wash with plenty of soap and water.
P353	Rinse skin with water/shower.
P360	Rinse immediately contaminated clothing and skin with plenty of water before removing clothes.
P361	Remove/Take off immediately all contaminated clothing.
P362	Take off contaminated clothing and wash before reuse.
P363	Wash contaminated clothing before reuse.
P370	In case of fire:
P371	In case of major fire and large quantities:
P372	Explosion risk in case of fire.
P373	DO NOT fight fire when fire reaches explosives.
P374	Fight fire with normal precautions from a reasonable distance.
P376	Stop leak if safe to do so. Oxidising gases (section 2.4) 1
P377	Leaking gas fire: Do not extinguish, unless leak can be stopped safely.
P378
P380	Evacuate area.
P381	Eliminate all ignition sources if safe to do so.
P390	Absorb spillage to prevent material damage.
P391	Collect spillage. Hazardous to the aquatic environment
P301 + P310	IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician.
P301 + P312	IF SWALLOWED: call a POISON CENTER or doctor/physician IF you feel unwell.
P301 + P330 + P331	IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P302 + P334	IF ON SKIN: Immerse in cool water/wrap in wet bandages.
P302 + P350	IF ON SKIN: Gently wash with plenty of soap and water.
P303 + P361 + P353	IF ON SKIN (or hair): Remove/Take off Immediately all contaminated clothing. Rinse SKIN with water/shower.
P304 + P312	IF INHALED: Call a POISON CENTER or doctor/physician if you feel unwell.
P304 + P340	IF INHALED: Remove victim to fresh air and Keep at rest in a position comfortable for breathing.
P304 + P341	IF INHALED: If breathing is difficult, remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305 + P351 + P338	IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P306 + P360	IF ON CLOTHING: Rinse Immediately contaminated CLOTHING and SKIN with plenty of water before removing clothes.
P307 + P311	IF exposed: call a POISON CENTER or doctor/physician.
P308 + P313	IF exposed or concerned: Get medical advice/attention.
P309 + P311	IF exposed or if you feel unwell: call a POISON CENTER or doctor/physician.
P332 + P313	IF SKIN irritation occurs: Get medical advice/attention.
P333 + P313	IF SKIN irritation or rash occurs: Get medical advice/attention.
P335 + P334	Brush off loose particles from skin. Immerse in cool water/wrap in wet bandages.
P337 + P313	IF eye irritation persists: Get medical advice/attention.
P342 + P311	IF experiencing respiratory symptoms: call a POISON CENTER or doctor/physician.
P370 + P376	In case of fire: Stop leak if safe to Do so.
P370 + P378	In case of fire:
P370 + P380	In case of fire: Evacuate area.
P370 + P380 + P375	In case of fire: Evacuate area. Fight fire remotely due to the risk of explosion.
P371 + P380 + P375	In case of major fire and large quantities: Evacuate area. Fight fire remotely due to the risk of explosion.
Storage
Code	Phrase
P401
P402	Store in a dry place.
P403	Store in a well-ventilated place.
P404	Store in a closed container.
P405	Store locked up.
P406	Store in corrosive resistant/ container with a resistant inner liner.
P407	Maintain air gap between stacks/pallets.
P410	Protect from sunlight.
P411
P412	Do not expose to temperatures exceeding 50 oC/ 122 oF.
P413
P420	Store away from other materials.
P422
P402 + P404	Store in a dry place. Store in a closed container.
P403 + P233	Store in a well-ventilated place. Keep container tightly closed.
P403 + P235	Store in a well-ventilated place. Keep cool.
P410 + P403	Protect from sunlight. Store in a well-ventilated place.
P410 + P412	Protect from sunlight. Do not expose to temperatures exceeding 50 oC/122oF.
P411 + P235	Keep cool.
Disposal
Code	Phrase
P501	Dispose of contents/container to ...
P502	Refer to manufacturer/supplier for information on recovery/recycling

Physical hazards
Code	Phrase
H200	Unstable explosive
H201	Explosive; mass explosion hazard
H202	Explosive; severe projection hazard
H203	Explosive; fire, blast or projection hazard
H204	Fire or projection hazard
H205	May mass explode in fire
H220	Extremely flammable gas
H221	Flammable gas
H222	Extremely flammable aerosol
H223	Flammable aerosol
H224	Extremely flammable liquid and vapour
H225	Highly flammable liquid and vapour
H226	Flammable liquid and vapour
H227	Combustible liquid
H228	Flammable solid
H229	Pressurized container: may burst if heated
H230	May react explosively even in the absence of air
H231	May react explosively even in the absence of air at elevated pressure and/or temperature
H240	Heating may cause an explosion
H241	Heating may cause a fire or explosion
H242	Heating may cause a fire
H250	Catches fire spontaneously if exposed to air
H251	Self-heating; may catch fire
H252	Self-heating in large quantities; may catch fire
H260	In contact with water releases flammable gases which may ignite spontaneously
H261	In contact with water releases flammable gas
H270	May cause or intensify fire; oxidizer
H271	May cause fire or explosion; strong oxidizer
H272	May intensify fire; oxidizer
H280	Contains gas under pressure; may explode if heated
H281	Contains refrigerated gas; may cause cryogenic burns or injury
H290	May be corrosive to metals
Health hazards
Code	Phrase
H300	Fatal if swallowed
H301	Toxic if swallowed
H302	Harmful if swallowed
H303	May be harmful if swallowed